Actively Recruiting
Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy
Led by Morten Steen Kvistholm Jensen · Updated on 2025-03-20
100
Participants Needed
4
Research Sites
39 weeks
Total Duration
On this page
Sponsors
M
Morten Steen Kvistholm Jensen
Lead Sponsor
V
Viborg Regional Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment effects of Bisoprolol, a beta 1 receptor-specific beta blocker, and Verapamil, a cardio-specific calcium channel blocker, in patients with non-obstructive hypertrophic cardiomyopathy (HCM). HCM is characterized by thickening of the left ventricular wall and increased sarcomere contraction, which reduces the left ventricular cavity size. Symptoms include breathlessness, chest pain, palpitations, and fainting, with risks of arrhythmias and sudden cardiac deaths. Current treatments include beta blockers and calcium channel blockers, but evidence on their effectiveness is limited. This study is a multicenter, randomized, triple-blinded, placebo-controlled crossover trial involving three 35-day treatment periods. Participants receive Bisoprolol, Verapamil, and placebo in random order, each period including a week of dose increase, three weeks at target dose, and a week of dose reduction. A 45-day treatment pause separates each period. Dosages can reach up to 7.5 mg per day for Bisoprolol and 360 mg per day for Verapamil. A subgroup will also undergo cardiac magnetic resonance imaging. During the trial, patients will undergo cardiopulmonary exercise testing, echocardiography, seven-day Holter monitoring, biomarker assessments, and complete the Kansas City Cardiomyopathy Questionnaire. Researchers will assess maximal oxygen consumption, left ventricular volume, and incidence of non-sustained ventricular tachycardia among other heart function measures. The study includes safety monitoring and evaluates symptoms, heart function, and arrhythmia occurrence over the treatment periods, with outcomes measured mainly at day 21 of each treatment.
CONDITIONS
Brief Title
Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Maximal left ventricular wall thickness of 15 mm or more not caused by hypertension, valve disease, or storage diseases
- New York Heart Association (NYHA) functional class II or higher, or a history of NYHA class II or higher before treatment with beta blockers or calcium channel blockers
- Pro-BNP above 300 ng/l or BNP above 100 ng/l
- Non-sustained ventricular tachycardia documented within the last 2 years of screening
You will not qualify if you...
- Left ventricular ejection fraction below 50%
- Left ventricular outflow tract gradient above 30 mmHg at rest or during Valsalva maneuver after stopping beta blockers or calcium channel blockers
- History of left ventricular outflow tract gradient above 30 mmHg at any time
- Permanent atrial fibrillation
- Permanent right ventricular pacing
- Previous intolerance to Bisoprolol or Verapamil
- Known obstructive coronary disease (previous intervention accepted)
- Estimated glomerular filtration rate below 40 ml/min
- Women under 50 who are pregnant, breastfeeding, or not using contraception
- Significant liver failure
- Severe valvular disease
- Bradycardia with heart rate below 40 bpm
- Low blood pressure with systolic below 100 mmHg
- Other significant health issues or risks related to stopping beta blockers or calcium channel blockers as judged by investigators
- Inability to understand patient information intellectually or linguistically
- Unable to perform exercise testing
- Unable to speak or understand Danish
- For cardiac MRI subgroup: any implantable cardioverter defibrillator, pacemaker, metal implants affecting imaging or posing risk, or inability to tolerate the MRI scanner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks per treatment period
Participants receive three different treatment periods with Verapamil, Bisoprolol, and Placebo in a randomized crossover design. Each treatment period includes a 1-week uptitration, 2 to 3 weeks of steady state treatment at the maximum tolerated dose, and a 1-week downtitration.
Visits approximately weekly during each treatment period
Trial Site Locations
Total: 4 locations
1
Department of Cardiology, Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
2
Department of Cardiology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
3
Department of Cardiology, Zealand University Hospital
Roskilde, Denmark, 4000
Not Yet Recruiting
4
Department of Cardiology, Regional Hospital Viborg
Viborg, Denmark, 8800
Not Yet Recruiting
Research Team
M
Morten SK Jensen
L
Louise Bjerregaard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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