Team based collaborative care model, facilitated by mHealth enabled and trained nurses, for management of heart failure with reduced ejection fraction in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomised controlled trial.

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.

Achieving the Latest American Heart Association and American College of Cardiology Therapeutic Goals for Hypertension With Combination Therapy and Its Effects on Blood Pressure and Central Hemodynamic Parameters.

The present United States and European treatment guidelines recommend that antihypertensive therapy be initiated with a combination of agents from different classes to facilitate the achievement of control of blood pressure (BP). This prospective, randomized, open-label study was conducted at 3 tertiary hospitals in India to evaluate the effects of combination therapy with an angiotensin receptor blocker and a calcium antagonist on office BP and central hemodynamic parameters in patients with untreated hypertension or uncontrolled BP (>130/>80 mm Hg) during treatment with antihypertensive monotherapy. Patients were randomized to treatment with telmisartan 40 mg/day + amlodipine 5 mg/day or telmisartan 40 mg/day + cilnidipine 10 mg/day. Change from baseline to 8 weeks of treatment was assessed for seated office BP, ambulatory BP monitoring, and seated central hemodynamics (central BP, aortic augmentation index, central aortic augmentation pressure, and pulse wave velocity). A total of 94 of 96 enrolled patients completed the study. From baseline to 8 weeks a significant decrease was observed in both telmisartan + amlodipine and telmisartan + cilnidipine groups for mean BP (148.0 ± 12.80 to 124.0 ± 10.4 and 144.5 ± 10.2 to 123.0 ± 10.0 mm Hg, respectively; both p <0.001); in only telmisartan + amlodipine group for mean central aortic systolic and diastolic BP (131.1 ± 19.1 to 119.7 ± 14.9 mm Hg [p <0.001] and 93.3 ± 12.0 to 89.2 ± 14.6 mm Hg [p = 0.0008], respectively) and for central aortic pulse wave velocity (7.6 ± 1.4 to 7.2 ± 1.3 m/s, p = 0.0011); in only telmisartan + cilnidipine group for aortic augmentation index (27.5 ± 14.6 to 22.3 ± 12.2; p = 0.0178). Heart rate was unchanged in both treatment groups. Combination therapy with an angiotensin receptor blocker and a calcium antagonist effectively reduced BP to below the new <130/80 mm Hg target and had favorable effects on central hemodynamics.

The Cardiology Society of India-Kerala Acute Heart Failure Registry: poor adherence to guideline-directed medical therapy.

AIMS: Data on the burden of acute heart failure (AHF) admissions, practice patterns, and outcomes are rare from India and other low- and middle-income countries. We aimed to describe the baseline characteristics, guideline-directed medical therapy (GDMT) prescribing patterns and 90-day mortality rates in patients admitted with AHF in Kerala, India. METHODS AND RESULTS: The Cardiology Society of India-Kerala Acute Heart Failure Registry (CSI-KHFR) is an observational registry from 50 hospitals in Kerala, India, with prospective follow-up. Consecutive patients with AHF, who consented to participate, were enrolled. The 2016 European Society of Cardiology criteria were used for the diagnosis of AHF. Kaplan-Meier survival analysis and Cox-proportional hazard models were used for data analysis. The variables in the MAGGIC risk score were used in the multivariable model. A total of 7507 patients with AHF (37% female) participated in the CSI-KHFR. The mean age was 64.3 (12.9) years. More than two-third had reduced ejection fraction (EF) (67.5%). Nearly one-fourth (28%) of patients with heart failure (HF) with reduced EF received GDMT. Overall, in-hospital and 90-day mortality rates were 7% and 11.6%, respectively. Prescriptions of different components of GDMT were independently associated with 90-day mortality. CONCLUSION: The CSI-KHFR recorded an in-hospital and 90-day mortality of 7% and 11.6%, respectively. Only one of four patients received GDMT. AHF mortality was independently associated with GDMT initiation. Quality improvement initiatives that focus on increasing GDMT prescription may improve the survival of HF patients in India.

Presentation, Management, and In-Hospital Outcomes of Patients with Acute Heart Failure in South India by Sex: A Secondary Analysis of a Prospective, Interrupted Time Series Study.

Background: Sex differences in presentation, management, and outcomes of heart failure (HF) have been observed, but it is uncertain whether these differences exist in South India. Objective: We describe sex differences in presentation, management, and in-hospital outcomes in patients hospitalized with HF in South India and explore sex-based differences in the effect of the quality improvement intervention in a secondary analysis of a prospective, interrupted time series study. Methods: The Heart Failure Quality Improvement in Kerala (HF QUIK) study evaluated the effect of a quality improvement toolkit on process of care measures and clinical outcomes in patients hospitalized with HF in eight hospitals in Kerala using an interrupted time series design from February 2018 to August 2018. The primary outcome was guideline-directed medical therapy (GDMT) at hospital discharge for patients with HF with reduced ejection fraction (HFrEF). We performed sex-stratified analyses using mixed effect logistic regression models. Results: Among 1,400 patients, 536 (38.3%) were female. Female patients were older (69.6 vs. 65 years, p < 0.001), were less likely to have an ischemic etiology of HF (control period: 78.2% vs. 87.5%; intervention period: 83.6% vs. 91.5%; p < 0.05 for both) and were less likely to undergo coronary angiography or percutaneous coronary intervention. The quality improvement intervention had similar effects on the odds of GDMT at discharge in females with HFrEF (adjusted OR 1.79, 95% CI 0.92, 3.47) and males with HFrEF (adjusted OR 1.68, 95% CI 1.07, 2.64, pinteraction = 0.69). Conclusions: We observed sex-specific differences in presentation and procedural management of patients with HF but no differences in the effect of the quality improvement intervention on discharge GDMT rates. Both male and female patients with HFrEF remained undertreated in the study intervention period, demonstrating the need for implementation strategies to close the HFrEF treatment gap in South India.

Risk Factors and Comorbidities in Young Indian Patients with Hypertension: REAL YOUNG (Hypertension) Study.

PURPOSE: To analyze the risk factors and comorbidities among the young Indian adults with hypertension. PATIENTS AND METHODS: This was a retrospective, multicentric real-world study which included patients diagnosed with and receiving treatment for hypertension. Data were collected from the medical records of clinics/hospitals across 623 study sites in India. Patients of either sex and aged 18-45 years were included. Demographic details (age, sex, anthropometric measurement), medical and family history, sedentary lifestyle, smoking status and alcohol consumption data were extracted. Descriptive and comparative analysis (Mann-Whitney U and chi-squared test) was done. RESULTS: Out of 15,006 young patients diagnosed with hypertension (men=63.6%), 65.7% belonged to the age group of >35-45 years. The median body mass index was 27.0 kg/m2. Patients diagnosed with only hypertension were 29.1% while other predominant comorbidities with hypertension were diabetes mellitus (42.4%) and dyslipidemia (7.8%). Hypertension with diabetes mellitus were prevalent in the age group of >35-45 years (43.8%). More than half of the patients with hypertension (n=7656) had a sedentary lifestyle. Overall, 35.6%, 47.3%, and 56.7% of the patients were alcoholic, smokers (present and former), and had a family history of hypertension, respectively. CONCLUSION: The results showed that among the young population, hypertension was common in the age group of >35-45 years and diabetes mellitus and dyslipidemia were common comorbidities. Family history, sedentary lifestyle, smoking, alcohol consumption, and body mass index may also contribute to hypertension.

One-year clinical outcome of patients with nonvalvular atrial fibrillation: Insights from KERALA-AF registry.

BACKGROUND: We report patient characteristics, treatment pattern and one-year clinical outcome of nonvalvular atrial fibrillation (NVAF) from Kerala, India. This cohort forms part of Kerala Atrial Fibrillation (KERALA-AF) registry which is an ongoing large prospective study. METHODS: KERALA-AF registry collected data of adults with previously or newly diagnosed atrial fibrillation (AF) during April 2016 to April 2017. A total of 3421 patients were recruited from 53 hospitals across Kerala state. We analysed one-year follow-up outcome of 2507 patients with NVAF. RESULTS: Mean age at recruitment was 67.2 years (range 18-98) and 54.8% were males. Main co-morbidities were hypertension (61.2%), hyperlipidaemia (46.2%) and diabetes mellitus (37.2%). Major co-existing diseases were chronic kidney disease (42.1%), coronary artery disease (41.6%), and chronic heart failure (26.4%). Mean CHA2DS2-VASc score was 3.18 (SD ± 1.7) and HAS-BLED score, 1.84 (SD ± 1.3). At baseline, use of oral anticoagulants (OAC) was 38.6% and antiplatelets 32.7%. On one-month follow-up use of OAC increased to 65.8% and antiplatelets to 48.3%. One-year all-cause mortality was 16.48 and hospitalization 20.65 per 100 person years. The main causes of death were cardiovascular (75.0%), stroke (13.1%) and others (11.9%). The major causes of hospitalizations were acute coronary syndrome (35.0%), followed by arrhythmia (29.5%) and heart failure (8.4%). CONCLUSIONS: Despite high risk profile of patients in this registry, use of OAC was suboptimal, whereas antiplatelets were used in nearly half of patients. A relatively high rate of annual mortality and hospitalization was observed in patients with NVAF in Kerala AF Registry.

Effect of a quality improvement intervention for acute heart failure in South India: An interrupted time series study.

BACKGROUND: Although quality improvement interventions for acute heart failure have been studied in high-income countries, none have been studied in low- or middle-income country settings where quality of care can be lower. We evaluated the effect of a quality improvement toolkit on process of care measures and clinical outcomes in patients hospitalized for acute heart failure in 8 hospitals in Kerala, India utilizing an interrupted time series design from February 2018 to August 2018. METHODS: The quality improvement toolkit included checklists, audit-and-feedback reports, and patient education materials. The primary outcome was rate of discharge guideline-directed medical therapy for patients with heart failure with reduced ejection fraction. We used mixed effect logistic regression and interrupted time series models for analysis. RESULTS: Among 1400 participants, mean (SD) age was 66.6 (12.2) years, and 38% were female. Mean (SD) left ventricular ejection fraction was 35.2% (9.7%). The primary outcome was observed in 41.3% of participants in the intervention period and 28.1% of participants in the control period (difference 13.2%; 95% CI 6.8, 19.0; adjusted OR = 1.70; 95% CI 1.17, 2.48). Interrupted time series model demonstrated highest rate of guideline-directed medical therapy at discharge in the initial weeks following intervention delivery with a concomitant decline over time. Improvements were observed in discharge process of care measures, including diet counseling, weight monitoring instructions, and scheduling of outpatient clinic follow-up but not hospital length of stay nor inpatient mortality. CONCLUSIONS: Higher rates of guideline-directed medical therapy at discharge were observed in Kerala. Broader implementation of this quality improvement intervention may improve heart failure care in low- and middle-income countries.

Multidisciplinary Consensus Document on the Management of Uncontrolled Hypertension in India.

Cardiovascular disease is predicted to be the largest cause of death and disability in India by 2020. Hypertension (HT), one of the main contributing factors, presents a significant public health burden. Inability to achieve adequate blood pressure (BP) control results in uncontrolled hypertension (UHT). The prevalence of UHT is high in India, with only about 9-20% of patients achieving target BP goals. Presently, there are no guidelines specific to UHT, which if left uncontrolled can lead to resistant HT, chronic kidney disease and other complications of HT. A multidisciplinary panel, comprising of specialists in cardiology, nephrology and internal medicine, was convened to address the diagnosis and management of UHT in the Indian population. The panel identified key points concerning UHT and discussed management recommendations in the Indian clinical setting.

Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction.

BACKGROUND: Despite a high cardiovascular disease burden, data on patient-reported health status outcomes among individuals with cardiovascular disease in India are limited. METHODS AND RESULTS: Between November 2014 and November 2016, we collected health-related quality of life data among 1261 participants in the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala). We used a translated, validated version of the Seattle Angina Questionnaire administered 30 days after discharge for acute myocardial infarction, wherein higher scores represent better health status. We compared results across sex, myocardial infarction type, and randomization status using regression models that account for clustering and temporal trends. Mean (SD) age was 60.8 (13.7) years, 62% were men, and 63% presented with ST-segment-elevation myocardial infarction. More than 2 out of 5 respondents (44%) experienced angina 30 days after hospitalization, but most (68% of respondents with angina; 27% of the total sample) experienced it less than once per week (Seattle Angina Questionnaire angina frequency score 60). Respondents rated high median (interquartile range [IQR]) scores for angina frequency (100.0 [80.0-100.0]) overall with similar unadjusted scores by sex, but between-hospitality variability was high. Median (IQR) physical limitation scale response was 58.3 (41.7-77.8), which is consistent with limitations in moderate- and high-intensity activities at 30-day follow-up. Older respondents had more angina frequency and physical limitations and lower treatment satisfaction and quality of life. Women had greater physical limitations (median [IQR], 52.8 [38.9-72.2] for women versus median [IQR], 61.1 [44.4-80.6] for men; P<0.01). Overall treatment satisfaction was high with median (IQR) score, 81.3 (75.0-93.8), but overall quality of life was lower with median (IQR) score, 66.7 (50.0-83.3). Allocation to the quality improvement intervention group had the strongest direct association with higher quality of life (difference, 4.2; P=0.03), but overall effects were modest. CONCLUSIONS: This study represents the largest report of quality of life among myocardial infarction survivors in India with variability across age, sex, and quality improvement intervention status. Wide variability demonstrated across hospitals warrants further study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02256657.

Infective endocarditis caused by Granulicatella adiacens.

Granulicatella adiacens, a recently nomenclatured bacterium, was considered as one of the nutritionally variant streptococci (NVS) and is a mouth commensal. It is redesignated as a streptococcus like bacterium since it differs from streptococci. We report a case of infective endocarditis (IE) caused by this fastidious and unusual bacteria in a 63-year-old man with rheumatic valvular heart disease. G. adiacens was isolated from four of his blood culture samples, which was sensitive to beta lactams, moderately sensitive to gentamicin and resistant to erythromycin and co-trimoxazole. Patient recovered completely on treatment with high dose of ampicillin and gentamicin for 28 days.