Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars).

BACKGROUND: We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting. METHODS: The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect. RESULTS: During December 2015-December 2016, a total of 4415 participants aged 50-75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4-4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups. CONCLUSIONS: The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level. TRIAL REGISTRATION NUMBER: NCT03459560.

The Effects of Coenzyme Q10 on Contrast-Induced Acute Kidney Injury in Type 2 Diabetes: A Randomized Clinical Trial.

Contrast-induced acute kidney injury (CI-AKI) is a frequent challenge following the injection of contrast media and its subsequent oxidative stress. The aim of the present study was to evaluate the preventive effects of coenzyme Q10 (Q10), as a mitochondrial-targeted antioxidant in CI-AKI in diabetic patients, who account for a large proportion of angiographic cases. A total of 118 diabetic patients were randomly assigned to receive 120 mg of oral coenzyme Q10 (Q10 group) or placebo (Placebo group) for four days, starting 24 hours before contrast media injection. Blood urea nitrogen (BUN), serum and urinary creatinine, estimated glomerular filtration rate (eGFR), urinary malondialdehyde (UMDA), urinary total antioxidant capacity (UTAC), and urinary mitochondrial to nuclearDNA ratios (mtDNA/nDNA ratio) were evaluated before and after the treatment period. Urine sediments were also evaluated to report the urine microscopy score (UMS).The levels of BUN, serum and urine creatinine, and UMS were similar in the Q10 and placebo groups. EGFR was lower in the Q10 group before the treatment (p=0.013) but not after. The urinary mtDNA/nDNA ratio was 3.05±1.68 and 3.69±2.58 in placebo and Q10 groups, but UTAC was found to be lower in Q10 both before (p=0.006) and after the treatment (p<0.001). The incidence of CI-AKI was 14.40% and the mtDNA/nNDA ratio was similar between CI-AKI and non-CI-AKI patients. In conclusion, Q10 treatment shows no favorable effect on prevention of CI-AKI or a urinary mtDNA/nDNA ratio among diabetic patients.

The incidence of myopericarditis in patients with COVID-19.

Introduction: SARS-COV-2 can affect different organ systems, including the cardiovascular system with wide spectrum of clinical presentations including the thrombotic complications, acute cardiovascular injury and myopericarditis. There is limited study regarding COVID-19 and myopericarditis. The aim of this study was to evaluate myopericarditis in patients with definite diagnosis of COVID-19. Methods: In this observational study we analyzed the admitted patients with definite diagnosis of COVID-19 based on positive RT-PCR test. Laboratory data, and ECG changes on days 1-3-5 were analyzed for sign of pericarditis and also QT interval prolongation. Echocardiography was performed on days 2-4 and repeated as necessary, and one month after discharge for possible late presentation of symptom. Any patient with pleuritic chest pain, and pericardial effusion and some rise in cardiac troponin were considered as myopericarditis. Results: A total of 404 patients (18-90 years old, median = 63, 273 males and 131 females) with definite diagnosis of COVID-19 were enrolled in the study. Five patients developed in-hospital pleuritic chest pain with mild left ventricular dysfunction and mild pericardial effusion and diagnosed as myopericarditis, none of them proceed to cardiac tamponade. We found no case of late myopericarditis. Conclusion: Myopericarditis, pericardial effusion and cardiac tamponade are rare complication of COVID-19 with prevalence about 1.2 %, but should be considered as a possible cause of hemodynamic deterioration.

Effect of Tricuspid Valve Repair in Patients with Moderate Tricuspid Regurgitation undergoing Left-Sided Valve Surgery.

BACKGROUND: The benefits of tricuspid valve (TV) repair in patients with moderate tricuspid regurgitation (TR) during left-sided valve surgery are under debate. We investigated independent predictors for reduction in TR severity following left-sided valve surgery in patients with moderate TR. METHODS: In this study, we included 106 patients (male: 33%) with a mean age of 4.23 ± 12.61 years who had moderate TR and underwent mitral or aortic valve surgery between March 2012 and November 2016. Concomitant tricuspid annuloplasty was done for one group of patients based on surgeon's decision. Transthoracic echocardiography was done before and at a median followup of 4.71 months for all patients. The patients were divided into improved and unimproved TR groups, with the term "improved" signifying a reduction of at least one grade in TR severity. RESULTS: Tricuspid annuloplasty was performed on 65 (61.3%) patients. TR improvement was observed in 87.7% of patients in the TV repair group and 56.1% of patients in the no-TV repair group, indicating a significant difference (P < 0.001). Tricuspid annulus diameter was not significantly different between the two groups (32.41 ± 4.68 mm in no-TV repair group and 33.87 ± 4.34 mm in TV repair group, P = 0.128). At follow-up with echocardiography, 80 (75.5%) patients were placed in the improved group and the majority of patients (71.3% vs. 30.8%; P < 0.001) underwent tricuspid repair in the improved group. TV annuloplasty was correlated with reduced TR severity following left-sided valve surgery (odds ratio [OR]: 5.19, 95% CI: 1.70-15.85, P < 0.001). TR changed from moderate to severe in 17 (17.1%) patients with no concomitant tricuspid repair, while only one patient (1.5%) with tricuspid repair showed an increased TR severity. CONCLUSION: Tricuspid annuloplasty may be useful in patients who have moderate TR undergoing left-sided valve surgery regardless of the tricuspid annulus diameter, and it can play an effective role in the improvement of TR at mid-term follow-up.

Comparison of the Effects of Enoxaparin and Heparin on Inflammatory Biomarkers in Patients with ST-segment Elevated Myocardial Infarction: A prospective Open Label Pilot Clinical Trial.

Heparin and enoxaparin possess anti-inflammatory properties. We compared the effects of these drugs on inflammatory biomarkers in patients with ST-segment Elevated Myocardial Infarction (STEMI). Thirty four patients with STEMI randomly separated in two groups and received standard doses of heparin and enoxaparin. The serum concentration of Serum Amyloid A (SAA), C-Reactive Protein (CRP), Interleukin (IL)-6, ferritin and Myeloperoxidase (MPO) were measured at baseline, 12 ,24 and 48 hours after drug administration. SERUM CONCENTRATIONS OF SAA (P: 0.02), CRP (P: 0.02) and ferritin (P: 0.01) significantly reduced in heparin group during measurements compared to baseline, circulating levels of IL-6 (P: 0.002), SAA (P: 0.009), CRP (P: 0.01) were significantly decreased in enoxaparin group. The overall difference in inflammatory biomarkers between heparin and enoxaparin group was not significant. Both heparin and enoxaparine reduced serum levels of inflammatory biomarkers in patients with STEMI. This effect may provide additional clinical benefit of these drugs in the treatment of STEMI patients.

Self-monitoring of blood pressure for improving adherence to antihypertensive medicines and blood pressure control: a randomized controlled trial.

BACKGROUND: Self-monitoring is reported to have limited efficacy for hypertension management in high-income countries. In this study, we aimed to evaluate the effect of self-monitoring on blood pressure (BP) control in an Iranian population. METHODS: A randomized controlled trial was conducted on 196 mild to moderate hypertensive patients in an outpatient cardiovascular clinic. Patients in the intervention group received a wrist self-monitoring device and were educated to measure and document their BP daily during the study period (24 weeks). Patients in the control group received usual care. Three follow-up visits with the physician were scheduled for all patients (weeks 4, 12, and 24), and the investigator assessed adherence to medications after each visit (pill counting). The primary outcome (BP) was compared between groups using repeated-measure analysis of variance. RESULTS: One hundred ninety patients completed the study. Systolic BP (144.4±7.4 vs 145.9±6.4mm Hg) and diastolic BP (85.5±6.9 vs. 85.1±7.7mm Hg) were similar between groups at baseline. The trend of BP was not significantly different between groups during the study period. Systolic and diastolic BP decreased significantly in both groups at the first follow-up visit (systolic BP: 132.6 vs. 133.4mm Hg; diastolic BP: 77.4 vs. 77.2mm Hg). In the intervention group, we observed a small continued decrease in diastolic BP up to week 24 BP (P = 0.01). Both groups showed adherence rates >95% during the study period. CONCLUSIONS: Our study could not confirm that self-monitoring can improve BP control in patients with frequent medical visits.

The effect of hibiscus sabdariffa on lipid profile, creatinine, and serum electrolytes: a randomized clinical trial.

Background. Hibiscus Sabdariffa L. (HS), a member of malvaceae family, is a medicinal plant with a worldwide fame. Its effect on reducing serum lipids is mentioned in several studies. The purpose of this study was to assess the efficacy of this plant in reducing the serum's lipids in hypertensive patients. Materials and Methods. Ninety hypertensive patients were randomly assigned to receive Hibiscus Sabdariffa (HS) tea or black tea for 15 days. The patients were asked to drink the tea within 20 minutes following its preparation. This process had to be repeated two times, daily. Patient's FBS and lipid profile were collected at the first visit day (day 0) and on the day 30. Results. There was no significant differences between pre and post experiment values within the two groups. An upward trend in total cholesterol, HDL, and LDL cholesterol was evident in both groups. The increase in total and HDL cholesterol in both groups relative to their initial values were significant. Conclusion. Hibiscus Sabdariffa is probably a safe medicinal plant. No significant harmful changes in cholesterol, triglyceride, BUN, serum creatinine, Na and K levels were observed within 15 days after the discontinuation of the medication.

The correlation between dyslipidemia and coronary artery disease based on angiographic findings in an Iranian population.

AIM: to evaluate the association between the presence of dyslipidemia and the findings of coronary angiography in an Iranian population. METHODS: this retrospective single center study was conducted on consecutive patients who underwent cardiac catheterization for cardiovascular symptoms in our center between March 2006 and 2007. The patients' medical records were studied in terms of clinical and demographic characteristics, lipid profile and angiography data. Pearson correlation analysis was used to assess the relationships between dyslipidemia and angiographic findings. RESULTS: a low but positive correlation was reported between having dyslipidemia and a positive angiography (r=0.092; P=0.035). When compared to patients with minimal angiographic coronary disease and single-vessel, dyslipidemia was more prevalent among those with more severe coronary diseases. CONCLUSION: dyslipidemia, particularly high triglyceride and low HDL levels, is linked with CAD identified by coronary angiography.