Effects of serelaxin in patients with acute heart failure

Background: Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. Methods: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 μg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. Results: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P=0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P=0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. Conclusions: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778. opens in new tab.

Baseline characteristics of patients in the reduction of events with darbepoetin alfa in heart failure trial (RED-HF)

<p>Aims: This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes.</p> <p>Methods and results: Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L.</p> <p>Conclusion: The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.</p&gt

Effects of serelaxin in patients with acute heart failure

49siSerelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure.openopenMetra M.; Teerlink J.R.; Cotter G.; Davison B.A.; Felker G.M.; Filippatos G.; Greenberg B.H.; Pang P.S.; Ponikowski P.; Voors A.A.; Adams K.F.; Anker S.D.; Arias-Mendoza A.; Avendano P.; Bacal F.; Bohm M.; Bortman G.; Cleland J.G.F.; Cohen-Solal A.; Crespo-Leiro M.G.; Dorobantu M.; Echeverria L.E.; Ferrari R.; Goland S.; Goncalvesova E.; Goudev A.; Kober L.; Lema-Osores J.; Levy P.D.; McDonald K.; Manga P.; Merkely B.; Mueller C.; Pieske B.; Silva-Cardoso J.; Spinar J.; Squire I.; Stepinska J.; Van Mieghem W.; Von Lewinski D.; Wikstrom G.; Yilmaz M.B.; Hagner N.; Holbro T.; Hua T.A.; Sabarwal S.V.; Severin T.; Szecsody P.; Gimpelewicz C.Metra, M.; Teerlink, J. R.; Cotter, G.; Davison, B. A.; Felker, G. M.; Filippatos, G.; Greenberg, B. H.; Pang, P. S.; Ponikowski, P.; Voors, A. A.; Adams, K. F.; Anker, S. D.; Arias-Mendoza, A.; Avendano, P.; Bacal, F.; Bohm, M.; Bortman, G.; Cleland, J. G. F.; Cohen-Solal, A.; Crespo-Leiro, M. G.; Dorobantu, M.; Echeverria, L. E.; Ferrari, R.; Goland, S.; Goncalvesova, E.; Goudev, A.; Kober, L.; Lema-Osores, J.; Levy, P. D.; Mcdonald, K.; Manga, P.; Merkely, B.; Mueller, C.; Pieske, B.; Silva-Cardoso, J.; Spinar, J.; Squire, I.; Stepinska, J.; Van Mieghem, W.; Von Lewinski, D.; Wikstrom, G.; Yilmaz, M. B.; Hagner, N.; Holbro, T.; Hua, T. A.; Sabarwal, S. V.; Severin, T.; Szecsody, P.; Gimpelewicz, C

y Effects of Serelaxin in Patients with Acute Heart Failure

BackgroundSerelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure.MethodsIn this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 mu g per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days.ResultsA total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P=0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P=0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups.ConclusionsIn this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.)In a randomized trial, 6545 patients with acute heart failure were assigned to either serelaxin or placebo in addition to standard care. There were no significant differences between the two groups in the incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days

Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005)

The aim of these guidelines is to provide updated practical guidelines for the diagnosis, assessment, and treatment of heart failure for use in clinical practice, as well as for epidemiological surveys and clinical trials. Particular attention in this update has been allocated to diastolic function and heart failure with preserved left ventricular ejection fraction (PLVEF). The intention has been to merge the previous Task Force report4 with the present update. The Guidelines are intended as a support for practising physicians and other health care professionals concerned with the management of heart failure patients and to provide advice on how to manage these patients, including recommendations for referral. Documented and published evidence on diagnosis, efficacy, and safety is the main basis for these guidelines