Search for a trial

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value <45%Secondary objectives:1) To…

Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

BAY 63 2521 is a direct stimulator of the soluble Guanylate Cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially Pulmonary Hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in the treatment of…

The effect of lipid lowering by Acipimox on cardiac and skeletal muscle mitochondrial function.

The major research objective is to investigate 1) whether lowering cardiac and muscular lipid content will improve mitochondrial and cellular function in type 2 diabetic patients, and 2) whether this lipid lowering effect also improves uncoupling in…

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…

A Phase II/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects with Acute Heart Failure

The objectives of this phase of the study are to confirm the efficacy of IV relaxin, in addition to standard therapy, in improving symptoms of heart failure, dyspnea, and in preventing intermediate term re-admission for HF or renal failure and…

Betablocker Therapy in Pulmonary Arterial Hypertension

The main question of this study is: *Is selective beta-blocker treatment safe and effective in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients with iPAH?*.In addition to the determination of RVEF, we will…

The influence of sunitinib on contractility of human atrial trabeculae

The primary objective of the study is to investigate the effect of sunitinib on ex-vivo atrial contractile force in absence and presence of ischemia-reperfusion. A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced…

A randomised, controlled, observer-blinded phase III clinical trial to compare the effect of intravenous ferric carboxymaltose to placebo on exercise capacity and cardiac function in patients with chronic heart failure and iron deficiency - EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac function in patients with iron deficiencY and chronic Heart Failure

Secondary objectives are to evaluate the effect of intravenous FCM compared to pla¬cebo on:1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.2.…

Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and al vessel wall thickness in patients with type 2 diabetes mellitus

To study the possible beneficial effect of simvastatin on accumulation of triglycerides in the myocardium of patients with DM2 and the effect on vessel wall thickness using magnetic resonance imaging and spectroscopy

Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6.5 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure

The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.

A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…

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…

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…

The Impact of glutamine suppletion on outcome in patients undergoing high-risk cardiothoracic surgery.

Aim of the study is to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on infectious, cardiac, cerebral, pulmonary and gastro-intestinal morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after…

Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure

The primary objective of this study is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of HF rehospitalization and all-cause mortality through 30 days after randomization [Day 30])…

Multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cardiac surgery

Primary objective: to demonstrate that tezosentan, in patients undergoing cardiac surgery with cardiopulmonary bypass, reduces the incidence of clinically relevant right ventricular failure resulting in difficult separation from bypass or need for…

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.

conform nederlandse tekst

A double-blind, randomised, placebo-controlled, combined single and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, including food interaction, and pharmacodynamic profile of BIA 5-1058, in healthy male volunteers.

Primary to assess the tolerability of the compound after single and multiple oral dosesSecondaryto measure the plasma and urine concentrations of the compound and its metabolites after single and multiple oral doses and to characterise its…

The development of a thirst provocation test using the AVP receptor antagonist Tolvaptan for quantification of thirst sensation in various patient groups (obese patients with and without a history of bariatric surgery, patients with congestive heart failure and patients with cranial diabetes insipidus as compared to healthy controls) and genotyping of the AVP receptor 2.

We aim to investigate thirst in the above mentioned patient groups, applying a Visual Analogue Scale (VAS) and, where ethically acceptable, a new thirst provocation test which we will develop in a group of healthy probands. Using these tools, we aim…