Comparing Bisoprolol and Verapamil for treating symptoms in patients with non-obstructive hypertrophic cardiomyopathy
Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy
This study tests whether Bisoprolol or Verapamil can help people with non-obstructive hypertrophic cardiomyopathy feel better by reducing symptoms like shortness of breath and chest pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Skejby Academic / other |
| Locations | 4 sites (Aarhus N and 3 other locations) |
| Trial ID | NCT05569382 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the treatment effects of Bisoprolol, a beta blocker, and Verapamil, a calcium channel blocker, in patients suffering from non-obstructive hypertrophic cardiomyopathy (HCM). The study will enroll symptomatic patients who meet specific criteria, including a certain level of heart wall thickness and functional class. Participants will receive either Bisoprolol, Verapamil, or a placebo to evaluate the effectiveness of these medications in alleviating symptoms such as dyspnea and chest pain. The trial is designed to provide insights into the optimal management of HCM symptoms and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic non-obstructive hypertrophic cardiomyopathy and specific heart wall thickness measurements.
Not a fit: Patients with obstructive coronary disease, significant left ventricular ejection fraction issues, or those who have previously shown intolerance to Bisoprolol or Verapamil may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with non-obstructive hypertrophic cardiomyopathy, improving their quality of life.
How similar studies have performed: Other studies have explored the use of beta blockers and calcium channel blockers in hypertrophic cardiomyopathy, indicating that this approach has potential but may vary in effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Left ventricular ejection fraction \< 50% * 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 anticonception. * Significant liver failure * Severe valvular disease * Bradycardia (40bpm) * 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 CMR sub study: * Implantable cardioverter defibrillator (any kind) * Pacemaker (any kind) * Metal implants like to affect image quality * Metal implants that poses a risk during CMR * Inability to cope with being in the scanner.
Where this trial is running
Aarhus N and 3 other locations
- Department of Cardiology, Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Department of Cardiology, Odense University Hospital — Odense, Denmark (Recruiting)
- Department of Cardiology, Zealand University Hospital — Roskilde, Denmark (Not_yet_recruiting)
- Department of Cardiology, Regional Hospital Viborg — Viborg, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Morten SK Jensen
- Email: morten.jensen@rm.dk
- Phone: 004540145482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.