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A placebo-controlled, double-blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and to evaluate the efficacy, pharmacokinetics, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome.

Primary ObjectivesTo evaluate the effect of MDCO-216 treatment on the change in PAV of a target coronary artery as measured by IVUS imaging following five weekly infusions of MDCO-216 (20 mg/kg) compared with placebo in subjects with a recent ACS.…

The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System in Reducing Functional Mitral Regurgitation (FMR) associated with heart failure.

The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a…

GENETIC-AF * A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure

The primary objective of this study is to compare the effects of bucindolol and metoprolol onthe recurrence of symptomatic AF/AFL in patients with HFREF who have a *1389 arginine homozygous(*1389Arg/Arg) genotype.The secondary objectives of this…

Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])

1. The primary objective is to assess the effects of four 250 mg PC-mAB (also referred to as "3G10") once monthly intravenous injections on monocyte function ex vivo. The secondary objectives are to:1. assess the functional effects of 3G10…

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the renal hemodynamic effects of RLX030 at a dose of 30 µg/kg/day or placebo infused for 24 hours in subjects with chronic heart failure (CHF).

Primary objective(s)To assess the effects of 24 hrs i.v. infusion of RLX030 30µg/kg/day compared to placebo on renal blood flow (RBF) as measured by PAH clearance in subjects with CHF and worsening symptoms To assess the effects of 24 hrs i.v.…

A randomized parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY 1021189 over 12 weeks in patients with worsening heart failure and reduced ejection fraction.

To characterize safety, tolerability, pharmacodynamic effects, and pharmacokinetics of the oral sGC stimulator BAY 1021189 in addition to standard therapy for heart failure with reduced EF (HFrEF) over 12 weeks in patients with worsening chronic…

A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure

The study primary goal is to determine the effectiveness of a single infusion of 1 x 10E13 DRP MYDICAR® in the coronary arteries in addition to an optimal HF regimen in patients with ischemic or non-ischemic cardiomyopathy and moderate to advanced…

A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects with Heart Failure and Left Ventricular Systolic Dysfunction

The primary objectives of this study are to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for in subjects with HF and left ventricular systolic dysfunction and to characterize itspharmacokinetics (PK) after 20 weeks…

Bosentan in Exercise Induced Pulmonary Arterial Hypertension in Congenital Heart Disease

Identify congenital heart disease patients with exercise-induced pulmonary arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in patients with exercise induced pulmonary arterial hypertension before and after…

Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction: the EXAMI trial

The primary objective is to determine whether additional treatment with exenatide in patients with acute myocardial infarction and treated with primary PCI, leads to a more preserved left ventricular function, compared to placebo in addition to…

A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of BAY 94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone versus eplerenone

Primary objective of the study is• To investigate efficacy and safety of different oraldoses of BAY94-8862 given once daily over 90 daysThe secondary objectives are:•To assess the effects of these doses on a compositeendpoint of death from any cause…

Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects with Chronic Heart Failure

Primary:Assess the safety of repeat doses of serelaxin in chronic heart failureSecondary:- Assess the incidence rate of adverse events of special interest, indicative of hypersensitivity reactions- Assess the safety and tolerability of repeated…

A Multi-Centre, Randomised, Double Blind, Placebo Controlled, Parallel Group Study of TA 8995 in Patients with Mild Dyslipidaemia, Alone and In Combination with Statin Therapy

The primary objective of this study is to evaluate the efficacy of different doses of TA 8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high density lipoprotein cholesterol (HDL C) and reduction of low density…

A randomized parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY 1021189 over 12 weeks in patients with worsening heart failure and preserved ejection fraction.

To characterize safety, tolerability, pharmacodynamic effects, and pharmacokinetics of the oral sGC stimulator BAY 1021189 in addition to standard diuretic and comorbidity treatment over 12 weeks in patients with worsening chronic heart failure with…

Randomized, double blind, placebo controlled, parallel group, multi-center study to evaluate the hemodynamic effects of Riociguat (BAY 63-2521) as well as safety and kinetics in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

The primary objective of this study is to : Assess the hemodynamic profile of Riociguat in patients with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction The secondary objectives of this study are to : -…

A multi-centre, double-blind, randomised, placebo-controlled trial using CD133 enriched bone marrow cells following primary angioplasty for acute myocardial infarction with central core laboratory analysis.

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A pivotal trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction â¤* The ADVANCE Trial

The objective of this study is to determine the Safety and Efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).Investigation of stem and regenerative cell therapy…

Maintenance of platelet inhiBition with cangreloR after dIscontinuation of
thienopyriDines in patients undergoing surGEry: The BRIDGE trial

The primary hypotheses in this study is that a cangrelor infusion will maintain target levels of platelet inhibition (> 60% inhibition) after discontinuation of a thienopyridine (clopidogrel or ticlopidine) in patients waiting for surgery.

Evaluation of the anti-arrhythmic effects of 3 oral dosages of S44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.

The aim of this study is to evaluate the anti-arrhythmic efficacy of S 44121 versus placebo administered orally for a total of 12 weeks in patients with chronic heart failure and left ventricular systolic dysfunction who received an implanted…

Phase IIb multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial for the assessment of coronary plaque changes with RVX000222, as determined by intravascular ultrasound

Primary ObjectiveTo evaluate the effect of RVX000222 on the change in burden of coronary atherosclerosis, as measured by percent atheroma volume (PAV), in patients with coronary artery disease and a low level of HDL-C requiring angiography for a…