Treatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy
- Conditions
- on-obstructive hypertrophic cardiomyopathyTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-515346-17-00
- Lead Sponsor
- Aarhus Universitetshospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
Age = 18 years, Maximal wall thickness = 15 mm unrelated to hypertension, valve diseases or storage diseases., And one of the following: 1. New York Heart Association – functional class (NYHA) = II 2. A history of NYHA class = II before treatment with BB or CCB 3. Pro-BNP>300 ng/l/35>nmol/l or BNP >100ng/l/>29nmol/l 4. Non-sustained VT (>120 min-1, =3 cycles) documented within the last 2 years of screening
Left ventricular ejection fraction < 50%, Significant liver failure, severe valvular disease, bradycardia (40bpm) or hypotension (systolic <100mmHg), other significant comorbidity or risks associated with discontinuation of BB or CCB after individual judgement by the investigators., Unable to understand patient information intellectually or linguistically, Unable to perform exercise test., Unable to speak and/or understand Danish., Additional exclusion criteria for CMRI sub-study: 1.Implantable cardioverter defibrillator (any kind): 2.Pacemaker (any kind): 3.Metal implants like to affect image quality: 4.Metal implants that poses a risk during CMRI: 5.Inability to cope with being in the scanner., LVOT gradient >30 mmHg at rest or during Valsalva maneuver after discontinuation of BB or CCB respectively, History of LVOT gradient >30 mmHg at rest, during exercise or during Valsalva maneuver., Permanent atrial fibrillation, Permanent right ventricular pacing, Previous intolerance for Bisoprolol (BB) or Verapamil (CCB), Known present obstructive coronary disease (previous percutaneous coronary intervention is accepted), eGFR < 40 ml/min, Fertile women (<50 years) who are pregnant (Positive Plasma-HCG), breastfeeding or not using anticonceptions.
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