Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure

Background Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. We assessed the effect of ibopamine on survival in patients with advanced heart failure in a multicentre, randomised placebo-controlled study. Methods Patients with advanced severe heart failure (New York Heart Association classes III and IV) and evidence of severe left-ventricular disease, who were already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The primary endpoint was all-cause mortality. The study was designed to recruit 2200 patients, and the minimum duration of treatment would be 6 months. We did intention-to-treat and on-treatment analyses; a post-hoc subgroup analysis was also done. Findings After we had recruited 1906 patients the trial was stopped early, because of an excess of deaths among patients in the ibopamine group. 232 (25%) of 953 patients in the ibopamine group died, compared with 193 (20%) of 953 patients in the placebo group (relative risk 1.26 [95% CI 1.04-1.53], p=0.017). The average length of follow-up was 347 days in the ibopamine group and 363 days in the placebo group. In multivariate analysis, only the use of antiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients. Interpretation Ibopamine seems to increase the risk of death among patients with advanced heart failure who are already receiving optimum therapy, but the reasons for this increase are not clear. Our finding that antiarrhythmic treatment was a significant predictor of increased mortality in ibopamine-treated patients may be important, but exploratory analyses must be interpreted with caution

Effects of exercise training on cardiac performance, exercise capacity and quality of life in patients with heart failure: a meta-analysis.

Contains fulltext : 50250.pdf (publisher's version ) (Closed access)BACKGROUND: Despite major advances in pharmacological treatment of chronic heart failure (CHF), a number of patients still suffer from dyspnoea, fatigue, diminished exercise capacity and poor quality of life. It is in this context that exercise training is being intensively evaluated for any additional benefit in the treatment of CHF. AIMS: To determine the effect of exercise training in patients with CHF on cardiac performance, exercise capacity and health-related quality of life. A meta-analysis was performed to obtain this goal. METHODS AND RESULTS: After including 35 randomised controlled trials, the methodological quality of each study was assessed, summary effect sizes (SESs) and the concomitant 95% confidence intervals (95% CI) were calculated for each outcome. Quantitative analysis showed statistically significant SESs, at rest, for diastolic blood pressure and end-diastolic volume. During maximal exercise, significant SESs were found for systolic blood pressure, heart rate, cardiac output, peak oxygen uptake, anaerobic threshold and 6-min walking test. The Minnesota Living with Heart Failure Questionnaire improved by an average of 9.7 points. CONCLUSIONS: Exercise training has clinically important effects on exercise capacity and HRQL, and may have small positive effects on cardiac performance during exercise