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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…

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 impact of dietary nitrate supplementation on exercise-induced cardiac troponin T release in type 2 diabetic patients: a pilot-study

To assess whether dietary nitrate supplementation blunts the ischemia-reperfusion-induced rise in cTnT levels following exercise in type 2 diabetic patients.

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…

A randomized, double blind, crossover, placebo controlled class-room experiment to assess the pharmacodynamics and pharmacokinetics of metoprolol in healthy volunteers with different polymorphism of CYP2D6

Primary Objective• To educate students about the full life cycle of clinical trials including study set-up, design, execution, analysis and reporting• To explore the influence of CYP2D6 polymorphism on the pharmacodynamics and pharmacokinetics of…

Active smoking and bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD): a hazardous combination in causing cardiovascular disease?

The aim of the study is to demonstrate a basic mechanism that supports our hypothesis: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds…

A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight versus Higher Body Weight Aspirin-Treated Subjects with Stable Coronary Artery Disease

The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects <60 kg with stable coronary artery disease (CAD) versus the…

Does atorvastatin have an acute and prolonged inhibitory effect on ischemia-reperfusion injury in humans in-vivo?

To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm. This to confirm results from our previous study.

A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Very Elderly versus Non-Elderly Aspirin-Treated Subjects with Stable Coronary Artery Disease

: The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects >=75 years of age with stable coronary artery disease (CAD)…

A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight versus Higher Body Weight Aspirin-Treated Subjects with Stable Coronary Artery Disease

The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects <60 kg with stable coronary artery disease (CAD) versus the…

A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Very Elderly versus Non-Elderly Aspirin-Treated Subjects with Stable Coronary Artery Disease

The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects >=75 years of age with stable coronary artery disease (CAD) versus…

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…

Explorative study on the impact of tea ingestion on forearm resistance artery endothelial function

To examine the acute impact of tea ingestion on forearm resistance artery endothelial function in middle-aged subjects

Does atorvastatin reduce ischemia-reperfusion injury in humans in-vivo?

To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.

The effect of rosiglitazone on ischemia-reperfusion-injury using annexin A5 scintigraphy.
A double blind placebo- controlled cross-over study in subjects with the metabolic syndrome

To estimate the effect of rosiglitazone compared to placebo on ischemia-reperfusion injury as assessed by annexin A5 scintigraphy in the human forearm in subjects with the metabolic syndrome.

The effect of ticagrelor on the adenosine system

To investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.

A Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Pharmacokinetics of DRL-17822 in Healthy Adult Male Volunteers

Part I (single ascending dose):To evaluate the safety and tolerability of ascending single doses of DRL-17822 in healthy male subjects;To evaluate the pharmacokinetics of ascending single doses of DRL-17822 in healthy male subjects;To determine CETP…

A single-center, randomized, double-blind, two-period cross-over study to investigate the effect of a single intravenous dose of rifampicin on the pharmacokinetics of ACT-246475 in healthy subjects.

The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of ACT-246475. Furthermore, the safety and tolerability of ACT-246475 when administered after administration of rifampicin, will…

TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fraction

Assess whether: trimetazidine treatment 1) improves LV diastology; 2) improves LV myocardial energy content in HFpEF.

Stratified Treatment to Ameliorate Diastolic left ventricular stIffness in eArly Heart Failure with preserved Ejection Fraction (STADIA-HFpEF)
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.

The primary objective is to assess in a 2x2 crossover design, whether compared to placebo dapagliflozin 10 mg od for 13 weeks improves LV distensibility, measured with echocardiography in patients with early HFpEF (LVEF >= 50%), defined as…