Comparing Bisoprolol and Verapamil for treating symptoms in patients with non-obstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

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• Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.