20 results
The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.
The primary objective of the study is to evaluate the effect of diuretics on right ventricular function and volume properties in patients with symptomatic right heart failure and PH.
The objective of the study is to obtain information on the bioavailability and pharmacokinetics of the phenolics present in an olive leaf extract (Bonolive®, dose 250 mg), standardized on 40% oleuropein, and to identify the composition of the…
The OneShotTM System procedure is designed to provide the anatomical and physiologic benefits of catheter-based RDN at lesser risk to the subject, due to a reduction of complexity of the procedure and design improvements intended to enhance…
To study dose-dependent hemodynamic and microcirculatory changes during oxygen supply in mechanically ventilated ICU patients.
Primary: To evaluate the safety of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.Secondary: To evaluate adverse events and study device performance.
Primary:To assess after administration of a single oral dose of 75 mg S 38844 containing 55 *Ci (2.035 MBq) of [14C]-S 38844:* The excretion balance of total radioactivity;* The pharmacokinetics of total radioactivity in blood and plasma;* The…
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…
In preparation for a large multi-center trial on the efficacy and safety of SENS for chronic intractable angina pectoris, we want to conduct a pilot, explorative trial to assess the feasibility, safety and efficacy of SENS implantation in this…
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…
Obtain information on the spatial movement and deflection of implanted leads by capturing three cardiac cycles with a simultaneous biplane cinefluoroscopy imaging system. The lead movement and deflection data will be used to evaluate the lead strain…
The aim of the current study is to compare the effects of supplementation with concentrated nitrate-rich beetroot juice versus dietary advice to increase dietary nitrate intake through the habitual diet. Therefore, we will assess the impact of 1-wk…
To evaluate the effect of diuretics on volumes and function of the right heart in pulmonary hypertension patients.
The primary objectives are to evaluate:-The effect of inclisiran treatment on the proportion of subjects achieving prespecified low densitylipoprotein cholesterol (LDL-C) targets at end of study (EOS)-The safety and tolerability profile of long term…
The primary objective of this study is to determine the accuracy of the technical performance of a newly developed non-invasive, continuous PPG-based BP algorithm by comparing absolute one-minute values of systolic (SBP) and diastolic (DBP) BP with…
This study has been transitioned to CTIS with ID 2024-515092-36-00 check the CTIS register for the current data. Primary• To assess safety and tolerability of acoramidis in participants with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM)…
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 25 mg dose of [14C]BAY 2433334 given as solution. For further clinical development, human mass balance data are required…
Primary:* To characterize the safety and tolerability of long-term administration of bempedoic acid (ETC-1002) 180 mgSecondary:* To characterize the efficacy of long-term administration of bempedoic acid 180 mg/day as assessed by changes in low-…
The purpose of the study is to investigate how quickly and to what extent BIA 5 1058 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The investigational compound will be labeled…
1) To explore the feasibility of running a psycho-educational support group including elements from cognitive behavioral therapy, acceptance and commitment therapy and mindfulness for ICD patients and their partners in Dutch hospitals; 2) To…