The Effect of Ivabradine Treatment on Exercise Capacity in Patients with Chronic Rejection after Heart Transplantatio
- Conditions
- Cardiac allograft vasculopathy and elevated resting heart rate in heart transplant recipientsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]MedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849
- Registration Number
- EUCTR2016-004706-33-DK
- Lead Sponsor
- Finn Gustafsson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
•Patients > 1 year post heart transplantation
•CAV verified by coronary angiography or IVUS
•Resting HR > 80 bpm
•Age > 18 years
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Rejection (>H1R) < 3 months
•Severe renal failure (estimated GFR < 30 mL/min/1.73 m2)
•Inability or contraindication to perform a VO2max test
•Presence of any condition that might per se influence exercise performance
•Known contraindication for treatment with ivabradine
•Hypersensitivity to the active substance or to any of the excipients of either study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method