Beta-Blockers after Myocardial Infarction and Preserved Ejection Fraction.

BACKGROUND: Most trials that have shown a benefit of beta-blocker treatment after myocardial infarction included patients with large myocardial infarctions and were conducted in an era before modern biomarker-based diagnosis of myocardial infarction and treatment with percutaneous coronary intervention, antithrombotic agents, high-intensity statins, and renin-angiotensin-aldosterone system antagonists. METHODS: In a parallel-group, open-label trial performed at 45 centers in Sweden, Estonia, and New Zealand, we randomly assigned patients with an acute myocardial infarction who had undergone coronary angiography and had a left ventricular ejection fraction of at least 50% to receive either long-term treatment with a beta-blocker (metoprolol or bisoprolol) or no beta-blocker treatment. The primary end point was a composite of death from any cause or new myocardial infarction. RESULTS: From September 2017 through May 2023, a total of 5020 patients were enrolled (95.4% of whom were from Sweden). The median follow-up was 3.5 years (interquartile range, 2.2 to 4.7). A primary end-point event occurred in 199 of 2508 patients (7.9%) in the beta-blocker group and in 208 of 2512 patients (8.3%) in the no-beta-blocker group (hazard ratio, 0.96; 95% confidence interval, 0.79 to 1.16; P = 0.64). Beta-blocker treatment did not appear to lead to a lower cumulative incidence of the secondary end points (death from any cause, 3.9% in the beta-blocker group and 4.1% in the no-beta-blocker group; death from cardiovascular causes, 1.5% and 1.3%, respectively; myocardial infarction, 4.5% and 4.7%; hospitalization for atrial fibrillation, 1.1% and 1.4%; and hospitalization for heart failure, 0.8% and 0.9%). With regard to safety end points, hospitalization for bradycardia, second- or third-degree atrioventricular block, hypotension, syncope, or implantation of a pacemaker occurred in 3.4% of the patients in the beta-blocker group and in 3.2% of those in the no-beta-blocker group; hospitalization for asthma or chronic obstructive pulmonary disease in 0.6% and 0.6%, respectively; and hospitalization for stroke in 1.4% and 1.8%. CONCLUSIONS: Among patients with acute myocardial infarction who underwent early coronary angiography and had a preserved left ventricular ejection fraction (≥50%), long-term beta-blocker treatment did not lead to a lower risk of the composite primary end point of death from any cause or new myocardial infarction than no beta-blocker use. (Funded by the Swedish Research Council and others; REDUCE-AMI ClinicalTrials.gov number, NCT03278509.).

Pharmacologic therapy among patients with type 2 diabetes mellitus admitted to the cardiology service.

AIM: To review the management of diabetes control in patients with type 2 diabetes admitted to the cardiology service at Auckland City Hospital for over 48 hours; to assess how many would potentially benefit from introduction of empagliflozin under current Pharmac guidelines. METHODS: A retrospective audit of all admissions into cardiology between 1 November 2020 and 31 January 2021 prior to the availability of empagliflozin. Data collected included diagnosis and presence of type 2 diabetes, HbA1c and diabetes medications. RESULTS: A total of 449 patients were admitted, of whom 98 had type 2 diabetes. The median age was 64 years old (IQR 56-76) and 66% of patients were male. Pacific peoples were over-represented in this study population. Fifty percent had an HbA1c>60mnmol/mol and diabetes medication was changed in 50% of these. Overall, 50% of patients would be eligible for empagliflozin under current criteria. CONCLUSIONS: High proportions of patients have poor glycaemic control and are not up-titrated, suggesting a missed opportunity for medication optimisation. Pacific peoples are over-represented in this group, suggesting that they are at high risk of diabetes and cardiovascular admissions. Empagliflozin provides a targeted way to address renal and cardiovascular outcomes.

Design and rationale of randomized evaluation of decreased usage of beta-blockers after acute myocardial infarction (REDUCE-AMI).

AIMS: Most trials showing benefit of beta-blocker treatment after myocardial infarction (MI) included patients with large MIs and are from an era before modern biomarker-based MI diagnosis and reperfusion treatment. The aim of the randomized evaluation of decreased usage of beta-blockers after acute myocardial infarction (REDUCE-AMI) trial is to determine whether long-term oral beta-blockade in patients with an acute MI and preserved left ventricular ejection fraction (EF) reduces the composite endpoint of death of any cause or recurrent MI. METHODS AND RESULTS: It is a registry-based, randomized, parallel, open-label, multicentre trial performed at 38 centres in Sweden, 1 centre in Estonia, and 6 centres in New Zealand. About 5000 patients with an acute MI who have undergone coronary angiography and with EF ≥ 50% will be randomized to long-term treatment with beta-blockade or not. The primary endpoint is the composite endpoint of death of any cause or new non-fatal MI. There are several secondary endpoints, including all-cause death, cardiovascular death, new MI, readmission because of heart failure and atrial fibrillation, symptoms, functional status, and health-related quality of life after 6-10 weeks and after 1 year of treatment. Safety endpoints are bradycardia, AV-block II-III, hypotension, syncope or need for pacemaker, asthma or chronic obstructive pulmonary disease, and stroke. CONCLUSION: The results from REDUCE-AMI will add important evidence regarding the effect of beta-blockers in patients with MI and preserved EF and may change guidelines and clinical practice.

Left ventricular thrombus after ST segment elevation myocardial infarction: a single-centre observational study.

AIMS: The incidence of left ventricular (LV) thrombus following ST segment elevation myocardial infarction (STEMI) has reduced with modern reperfusion therapies. There is scant local data on the incidence and outcomes of LV thrombus in the contemporary era of rapid reperfusion. METHODS: Patients with STEMI admitted to Auckland City Hospital between January 2014 and December 2015 were identified using the All New Zealand Acute Coronary Syndrome Quality Improvement (ANZACS-QI) registry and their clinical notes were retrospectively reviewed. RESULTS: Among the 997 patients admitted with STEMI, 53 patients (5%) had LV thrombus. Most patients with LV thrombus had an anterior STEMI (87%). The median time from admission to echocardiography was 48 hours (range 6-552 hours); the median LV ejection fraction was 38% (range 15-53%). Oral anticoagulation was initiated in 44 (83%) patients. LV thrombus resolved in 81% by six months in 42 patients given warfarin. Total mortality at 12 months was 13%. Bleeding occurred in 11% and was the most common treatment-related morbidity. CONCLUSIONS: The incidence of LV thrombus following STEMI was low and it was associated with a low rate of stroke and systemic embolism but high mortality. Randomised studies are needed to evaluate the efficacy of NOAC's in this context.

Hui: a partnership in practice in familial hypercholesterolemia.

AIMS: To empower a large whanau (extended family) with a history of severe premature heart disease and familial hypercholesterolemia (FH). METHODS: After broad consultation a Hui was held to discuss how to better manage this issue to ensure present and future generations were appropriately screened and treated. RESULTS: A closed social media page with detailed information on how to manage and screen FH that includes a family tree (for those who consent) has been created. The whanau, facilitated by health professionals, have ownership of their health. This has led to an uptake of screening and treatment for FH with whanau who are now able to inform local health professionals about their disorder. CONCLUSION: FH is the most common dominant genetic disorder in humans and causes premature heart disease and death. Current approaches are dependent on index patients presenting for cascade screening and do not incorporate the needs and views of the extended whanau. Establishing a partnership with the whanau and giving back control of health information is crucial to ensure equity. A national systematic programme is also needed to manage this condition with important health outcomes that can be averted if treated from a young age.

A pragmatic diagnostic approach to myocardial infarction with non-obstructive coronary arteries.

Myocardial infarction with non-obstructive coronary arteries (MINOCA) is an increasingly recognised condition and it accounts for approximately 10% of all cases of MI. Despite the absence of obstructive coronary artery disease, patients with MINOCA are at increased risk of morbidity and mortality compared to the general population. While many well recognised conditions can present as MINOCA, it can be difficult to reach a final diagnosis with certainty due to the relative infrequency of these conditions in the general population and the lack of diagnostic gold-standard tests. The most common causes of MINOCA are myocarditis, coronary vasospasm, coronary plaque disruption and coronary thrombus or embolism. These can be assessed by way of cardiac magnetic resonance imaging, intra-coronary imaging modalities and clinically relevant diagnostic blood tests, respectively. There are less common and rarer aetiologies which should be considered in the absence of an apparent cause, each with a unique diagnostic standard. By following a systematic approach of diagnostic tests, an underlying cause of MINOCA can be found in the majority of cases, allowing a directed management strategy to be pursued.

Fasting prior to cardiac catheterisation: a single-centre observational study.

AIM: Previous generation contrast agents were associated with high rates of nausea, vomiting and risk of aspiration leading to recommendations to fast prior to the procedure. However, modern contrast agents are well tolerated with a low risk of aspiration. Our current guidelines recommend fasting four to six hours before elective and semi-urgent cardiac catheterisation despite a lack of evidence to support this. We sought to determine the duration and effects of fasting at our centre. METHODS: A single-centre prospective observational study in patients undergoing elective cardiac catheterisation over a six-month period between 7 August 2017 to 7 February 2018 at Auckland City Hospital, New Zealand. RESULTS: One thousand and thirty patients with a mean age of 66±12 years underwent catheterisation. Sixty-seven percent were male, 26% had diabetes, 72% had hypertension and 23% had stage 3 or worse chronic kidney disease. The mean duration of fasting was 11.6±4.9 hours with 80% fasting longer than recommended. One hundred and eight (48%) patients with documented chronic kidney disease did not receive recommended pre-hydration. The most common symptoms related to fasting were hunger (47 %), nausea (3.9%) and vomiting (0.8%). Hypertension (4.1%) and hyperglycaemia (0.8%) occurred due to missed medication. There were no reports of aspiration. CONCLUSION: Most patients were fasted for significantly longer than recommended and pre-hydration was underutilised in patients at high risk of contrast-induced nephropathy. There were no episodes of aspiration with modern contrast agents. Further studies are required to evaluate the need for fasting prior to non-emergency cardiac catheterisation.

Intensity and duration of lifestyle interventions for long-term weight loss and association with mortality: a meta-analysis of randomised trials.

OBJECTIVES: To evaluate the importance of the frequency and duration of lifestyle interventions for achieving weight loss over ≥1 year and associations with all-cause mortality. DESIGN: Meta-analysis of randomised trials using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and RevMan software version 5·2 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen). DATA SOURCES: MEDLINE, CENTRAL, Google and Science Direct databases alongside reference lists of appropriate articles and meta-analyses. ELIGIBILITY CRITERIA: Randomised studies published in English-language journals from 1980 to June 2018 that assessed lifestyle compared with control interventions on weight loss and that included ≥100 subjects and reported weight change and mortality for ≥1 year. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data and assessed risk of bias. Data were pooled using the generic inverse-variance method and expressed as mean differences (MDs) with 95% CI and OR with 95% CI as appropriate. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic). The Grading of Recommendations Assessment, Development, and Evaluation score was used to assess the certainty of the evidence. RESULTS: 31 randomised trials with a total of 20 816 overweight or obese participants were included. 70% of participants had cardiometabolic risk factors. Body weight was lower for lifestyle intervention compared with the control at 1 year (3.63 kg, 95% CI 2.58 to 4.67) and at 3 years (2.45 kg, 95% CI 1.17 to 3.73). Weight loss at 1 year was greater in studies with >28 compared with ≤28 interventions per year (4.50 kg, 95% CI 3.03, 5.97 vs 2.38, 95% CI 0.78 to 3.98 kg, p=0.001). In all studies, there were 593 deaths (~0.3%/year). The ORs for mortality for weight loss interventions compared with the controls was 0.86 (95% CI 0.73 to 1.02), p=0.09. CONCLUSION: In predominantly healthy populations with risk factors, there is a dose response with number of lifestyle interventions and weight loss. Frequent and sustained interventions are needed to achieve a clinically significant 5% weight loss. There was insufficient evidence to reliably evaluate the benefits in persons with known cardiovascular disease or cancer. TRIAL REGISTRATION NUMBER: CRD42018095067.

Nature and delivery of cardiac rehabilitation in New Zealand: are services equitable to other high-income countries?

AIMS: To compare the nature and delivery of cardiac rehabilitation (CR) services within New Zealand by island (North vs South; NI, SI), and to other high-income countries (HICs). METHODS: In this cross-sectional study, secondary analysis of an online survey of CR programmes globally was undertaken. Results from New Zealand were compared to data from other HICs with CR. RESULTS: Twenty-seven (62.7%) out of 43 CR programmes in New Zealand (n=18/31, 66.7% respondents from NI) and 619 (43.1%) from 28 other HICs completed the survey. New Zealand CR programmes offered a median of 16.0 sessions/patient (interquartile range (IQR)=12.0-36.0; vs 21.6 sessions in other HICs, IQR=12.0-36.0, p=0.016), delivered by a team of 6.0 staff (IQR=5.5-7.0; vs 7.0 staff; IQR=5.0-9.0, p=0.012). New Zealand programmes were significantly less comprehensive than other HICs (p=0.002); within New Zealand, NI programmes were more likely to provide an initial and end-of-programme assessment, supervised exercise training and depression screening, compared to SI programmes (all p<0.05). New Zealand more often offered CR in an alternative setting (n=14, 58.3%), compared to other HICs (n=190, 36.5%), p=0.03). CONCLUSIONS: CR programmes in New Zealand offer fewer sessions and have fewer elements compared to other HICs, and disparity exists in programmes across New Zealand. More investment is needed to ensure CR in New Zealand meets international guidelines.

Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial.

OBJECTIVE: Compare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD). METHODS: Participants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics. Outcomes assessed at baseline, 12 and/or 24 weeks included maximal oxygen uptake (V̇O2max, primary) modifiable cardiovascular risk factors, exercise adherence, motivation, health-related quality of life and programme delivery, hospital service utilisation and medication costs. The primary hypothesis was a non-inferior between-group difference in V̇O2max at 12 weeks (inferiority margin=-1.25 mL/kg/min); inferiority margins were not set for secondary outcomes. RESULTS: 162 participants (mean 61±12.7 years, 86% men) were randomised. V̇O2 max was comparable in both groups at 12 weeks and REMOTE-CR was non-inferior to CBexCR (REMOTE-CR-CBexCR adjusted mean difference (AMD)=0.51 (95% CI -0.97 to 1.98) mL/kg/min, p=0.48). REMOTE-CR participants were less sedentary at 24 weeks (AMD=-61.5 (95% CI -117.8 to -5.3) min/day, p=0.03), while CBexCR participants had smaller waist (AMD=1.71 (95% CI 0.09 to 3.34) cm, p=0.04) and hip circumferences (AMD=1.16 (95% CI 0.06 to 2.27) cm, p=0.04) at 12 weeks. No other between-group differences were detected. Per capita programme delivery (NZD1130/GBP573 vs NZD3466/GBP1758) and medication costs (NZD331/GBP168 vs NZD605/GBP307, p=0.02) were lower for REMOTE-CR. Hospital service utilisation costs were not statistically significantly different (NZD3459/GBP1754 vs NZD5464/GBP2771, p=0.20). CONCLUSION: REMOTE-CR is an effective, cost-efficient alternative delivery model that could-as a complement to existing services-improve overall utilisation rates by increasing reach and satisfying unique participant preferences.

Cardiometabolic risk factors in vegans; A meta-analysis of observational studies.

BACKGROUND: There is increasing evidence that plant based diets are associated with lower cardiovascular risk. OBJECTIVE: To evaluate effects of a vegan compared to an omnivorous diet on cardio-metabolic risk factors. METHODS: Meta-analysis of observational studies published between 1960 and June 2018 that reported one or more cardio-metabolic risk factors in vegans and controls eating an omnivorous diet were undertaken. Macro-nutrient intake and cardio-metabolic risk factors were compared by dietary pattern. The Newcastle Ottawa Scale (NOS) was used to assess the quality of each study. The inverse-variance method was used to pool mean differences. Statistical analyses were performed using RevMan software version 5•2 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen. RESULTS: 40 studies with 12 619 vegans and 179 630 omnivores were included. From food frequency questionnaires in 28 studies, vegans compared to omnivores consumed less energy (-11%, 95% confidence interval -14 to -8) and less saturated fat (- 51%, CI -57 to -45). Compared to controls vegans had a lower body mass index (-1.72 kg/m2, CI -2.30 to -1.16), waist circumference (-2.35 cm, CI -3.93 to -0.76), low density lipoprotein cholesterol (-0.49 mmol/L CI -0.62 to -0.36), triglycerides (-0.14 mmol/L, CI -0.24 to -0.05), fasting blood glucose (-0.23 mmol/, CI -0.35 to -0.10), and systolic (-2.56 mmHg, CI -4.66 to -0.45) and diastolic blood pressure (-1.33 mmHg, CI -2.67 to -0.02), p<0.0001 for all. Results were consistent for studies with < and ≥ 50 vegans, and published before and after 2010. However in several large studies from Taiwan a vegan diet was not associated with favourable cardio-metabolic risk factors compared to the control diets. CONCLUSION: In most countries a vegan diet is associated with a more favourable cardio- metabolic profile compared to an omnivorous diet.

Text4Heart II - improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand. METHODS: Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. DISCUSSION: The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016.

Cardiac rehabilitation in New Zealand-moving forward.

Modern guideline-based cardiac rehabilitation provides an evidence-based, cost effective and comprehensive approach to reduce re-infarction and mortality. It offers a multidisciplinary approach to support self-management, improves psychological and social functioning and adherence to recommended life-style changes and medications. The challenge is to broaden uptake of cardiac rehabilitation, increase participation in supervised exercise programs and ensure that healthy behaviours are maintained in the long term. Shared care planning between cardiac rehabilitation specialists and primary health providers could improve long-term adherence by ensuring continuity of care of patients who have completed a Phase 2 cardiac rehabilitation program, either facility or home based.

Dietary patterns and the risk of major adverse cardiovascular events in a global study of high-risk patients with stable coronary heart disease.

OBJECTIVES: To determine whether dietary pattern assessed by a simple self-administered food frequency questionnaire is associated with major adverse cardiovascular events (MACE) in high-risk patients with stable coronary artery disease. BACKGROUND: A Mediterranean dietary pattern has been associated with lower cardiovascular (CV) mortality. It is less certain whether foods common in western diets are associated with CV risk. METHODS: At baseline, 15 482 (97.8%) patients (mean age 67 ± 9 years) with stable coronary heart disease from 39 countries who participated in the Stabilisation of atherosclerotic plaque by initiation of darapladib therapy (STABILITY) trial completed a life style questionnaire which included questions on common foods. A Mediterranean diet score (MDS) was calculated for increasing consumption of whole grains, fruits, vegetables, legumes, fish, and alcohol, and for less meat, and a 'Western diet score' (WDS) for increasing consumption of refined grains, sweets and deserts, sugared drinks, and deep fried foods. A multi-variable Cox proportional hazards models assessed associations between MDS or WDS and MACE, defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. RESULTS: After a median follow-up of 3.7 years MACE occurred in 7.3% of 2885 subjects with an MDS ≥15, 10.5% of 4018 subjects with an MDS of 13-14, and 10.8% of 8579 subjects with an MDS ≤12. A one unit increase in MDS >12 was associated with lower MACE after adjusting for all covariates (+1 category HR 0.95, 95% CI 0.91, 0.98, P = 0.002). There was no association between WDS (adjusted model +1 category HR 0.99, 95% CI 0.97, 1.01) and MACE. CONCLUSION: Greater consumption of healthy foods may be more important for secondary prevention of coronary artery disease than avoidance of less healthy foods typical of Western diets.

Living longer by sitting less and moving more.

PURPOSE OF REVIEW: Regular exercise, physical fitness and sedentary behaviours are each known to be associated with cardiovascular and total mortality. This review evaluates recent research on these associations and its implications for guidelines on physical activity. RECENT FINDINGS: In several large cohort studies, modest levels of exercise, much less than recommended in current guidelines, were associated with lower mortality. Avoiding prolonged sitting has also been associated with lower mortality risk. Most research suggests graded decreases in long-term mortality with an increase in usual physical activity and fitness. However, at very high exercise levels, these benefits may be attenuated, particularly in patients with known coronary heart disease. SUMMARY: In sedentary persons, a modest increase in physical activity and avoiding prolonged sitting are likely to have important health benefits. Further research is needed to determine the most effective strategies for increasing physical activity.

The remote exercise monitoring trial for exercise-based cardiac rehabilitation (REMOTE-CR): a randomised controlled trial protocol.

BACKGROUND: Exercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease. Despite the benefits associated with regular exercise, adherence with supervised exercise-based cardiac rehabilitation remains low. Increasingly powerful mobile technologies, such as smartphones and wireless physiological sensors, may extend the capability of exercise-based cardiac rehabilitation by enabling real-time exercise monitoring for those with coronary heart disease. This study compares the effectiveness of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (REMOTE) to standard supervised exercise-based cardiac rehabilitation in New Zealand adults with a diagnosis of coronary heart disease. METHODS/DESIGN: A two-arm, parallel, non-inferiority, randomised controlled trial will be conducted at two sites in New Zealand. One hundred and sixty two participants will be randomised at a 1:1 ratio to receive a 12-week program of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (intervention), or an 8-12 program of standard supervised exercise-based cardiac rehabilitation (control).The primary outcome is post-treatment maximal oxygen uptake (V̇O2max). Secondary outcomes include cardiovascular risk factors (blood lipid and glucose concentrations, blood pressure, anthropometry), self-efficacy, intentions and motivation to be active, objectively measured physical activity, self-reported leisure time exercise and health-related quality of life. Cost information will also be collected to compare the two modes of delivery. All outcomes are assessed at baseline, post-treatment, and 6 months, except for V̇O2max, blood lipid and glucose concentrations, which are assessed at baseline and post-treatment only. DISCUSSION: This novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach. If the REMOTE program proves to be as effective as traditional cardiac rehabilitation, it has potential to augment current practice by increasing access for those who cannot utilise existing services. TRIAL REGISTRATION: Australian New Zealand Clinical Trials RegistryStudy ID number: ACTRN12614000843651. Registered 7 August 2014.

The effects of changing dairy intake on trans and saturated fatty acid levels- results from a randomized controlled study.

BACKGROUND: Dairy food is an important natural source of saturated and trans fatty acids in the human diet. This study evaluates the effect of dietary advice to change dairy food intake on plasma fatty acid levels known to be present in milk in healthy volunteers. METHODS: Twenty one samples of whole fat dairy milk were analyzed for fatty acids levels. Changes in levels of plasma phospholipid levels were evaluated in 180 healthy volunteers randomized to increase, not change or reduce dairy intake for one month. Fatty acids were measured by gas chromatography-mass spectrometry and levels are normalized to d-4 alanine. RESULTS: The long chain fatty acids palmitic (13.4%), stearic (16.7%) and myristic (18.9%) acid were most common saturated fats in milk. Four trans fatty acids constituted 3.7% of the total milk fat content. Increased dairy food intake by 3.0 (± 1.2) serves/ day for 1 month was associated with small increases in plasma levels of myristic (+0.05, 95% confidence level-0.08 to 0.13, p = 0.07), pentadecanoic (+0.014, 95% confidence level -0.016 to 0.048, p = 0.02) and margaric acid (+0.02, -0.03 to 0.05, p = 0.03). There was no significant change in plasma levels of 4 saturated, 4 trans and 10 unsaturated fatty acids. Decreasing dairy food intake by 2.5 (± 1.2) serves per day was not associated with change in levels of any plasma fatty acid levels. CONCLUSION: Dietary advice to change dairy food has a minor effect on plasma fatty acid levels. TRIAL REGISTRATION: ACTRN12612000574842.

A randomized trial evaluating the effects of change in dairy food consumption on cardio-metabolic risk factors.

BACKGROUND: It is currently not known whether dairy food influences the risk of cardiovascular disease or diabetes. This study evaluates effects of changing dairy intake on cardio-metabolic risk factors. METHODS: 180 healthy volunteers were randomised to increase, reduce or not change their dairy intake for 1 month in response to dietary advice. Body weight, waist circumference, blood pressure, fasting plasma lipids, insulin resistance and C-reactive protein (CRP) were measured at baseline and after 1 month and compared by dietary group. RESULTS: 176 (98%) subjects completed the study. Average change in self-reported dairy fat intake for increased dairy food was +0.9 SD 1.1 g/day (+71%), no change was -2.1 SD 0.4 g/day (-15%) and decreased dairy food was -10.8 SD 1.2 g/day (-77%) respectively. There was no statistically significant change in LDL or HDL cholesterol, triglycerides, systolic or diastolic blood pressure, C-reactive protein, glucose or insulin with 95% CI standard mean differences <0.2 for all and CRP <0.3. There was a small increase in weight (+0.4 kg, SD 3.1) in those asked to increase dairy food. CONCLUSIONS: In healthy volunteers, dietary advice to change dairy intake for 1 month did not have a clinically significant effect on cardio-metabolic risk factors. These observations suggest that dairy food can be included as part of a normal healthy diet without increasing cardio-metabolic risk. TRIAL REGISTRATION NUMBER: ACTRN12612000574842.

Effects of high and low fat dairy food on cardio-metabolic risk factors: a meta-analysis of randomized studies.

IMPORTANCE: Clear guidelines on the health effects of dairy food are important given the high prevalence of obesity, cardiovascular disease and diabetes, and increasing global consumption of dairy food. OBJECTIVE: To evaluate the effects of increased dairy food on cardio metabolic risk factors. DATA SOURCES: Searches were performed until April 2013 using MEDLINE, Science Direct, Google,Embase, the Cochrane Central Register of Controlled Trials, reference lists of articles, and proceedings of major meetings. STUDY SELECTION: Randomized controlled studies with healthy adults randomized to increased dairy food for more than one month without additional interventions. DATA EXTRACTION AND SYNTHESIS: A standard list was used to extract descriptive, methodological and key variables from all eligible studies. If data was not included in the published report corresponding authors were contacted. RESULTS: 20 studies with 1677 participants with a median duration of dietary change of 26 (IQR 10-39) weeks and mean increase in dairy food intake of 3.6 (SD 0.92) serves/day were included. Increased dairy food intake was associated with a modest weight gain (+0.59, 95% confidence interval 0.34 to 0.84kg, p<0.0001) but no significant change in waist circumference (0.35 , -0.75 to 1.45 cm); insulin resistance (HOMA ­IR -0.94 , -1.93 to 0.05 units); fasting glucose (0.87, -0.27 to 2.01 mg/dl); LDL-cholesterol (1.36 ,-2.38 to 5.09 mg/dl); HDL-cholesterol (0.45, -2.13 to 3.04 mg/dl); systolic (-0.13, -1.73 to 1.98 mmHg) and diastolic blood pressure (0.13, -1.73 to 1.98 mmHg) or C-reactive protein (-0.08, -0.63 to 0.48 mg/L). Results were similar for studies with low-fat and whole-fat dairy interventions. LIMITATIONS: Most clinical trials were small and of modest quality. . CONCLUSION: Increasing whole fat and low fat dairy food consumption increases weight but has minor effects on other cardio-metabolic risk factors. TRIAL REGISTRATION ACTRN: Australian New Zealand Clinical Trials Registry ACTRN12613000401752, http://www.anzctr.org.au. ETHICS APPROVAL NUMBER: NTX/10/11/115.

Improving the informed consent process--a booklet on participants' rights in medical research.

AIM: This paper describes the process undertaken to develop and validate a booklet that informs participants of their rights in clinical studies. A booklet coupled with a shorter study-specific informed consent form may improve informed consent. METHODS: A booklet was developed in simple clear language, based on information contained in currently used audited informed consent forms and good clinical practice guidelines. 159 people from a broad range of backgrounds with expertise or interest in the consent process were asked to review the booklet and complete a survey. The booklet was modified based on feedback received from 59 respondents. RESULTS: Feedback was used to improve the booklet and ensure it complied with guidelines, was legally accurate and sensitive to tanga te whenua (Maori/indigenous people). The booklet was easier to read and comprehend compared to equivalent information contained in currently used informed consent forms. CONCLUSIONS: A broad consultation and revisions improved the booklet and suggested it would be well received if introduced in New Zealand together with shorter study-specific informed consent forms.