Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy

Launched by MORTEN STEEN KVISTHOLM JENSEN · Oct 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective two different medications, Bisoprolol and Verapamil, are in treating patients with non-obstructive hypertrophic cardiomyopathy (HCM), a heart condition that can cause symptoms like shortness of breath, chest pain, and heart palpitations. The trial aims to see which medication works better for improving heart function and exercise capacity in these patients. Participants in the study will be randomly assigned to receive Bisoprolol, Verapamil, or a placebo (a sugar pill that has no active ingredients) over three separate treatment periods. Each period lasts about 35 days, including time for the dose to be increased and then decreased. Throughout the trial, patients will undergo various tests to monitor their heart health.

To join the trial, participants must be at least 18 years old and have specific heart measurements and symptoms, but they should not have certain other heart conditions or severe illnesses. Those who qualify will be closely monitored and can expect to take part in exercise tests and other assessments to track how well the treatments are working. This study is important because it seeks to provide better evidence on how to treat a condition that can lead to serious complications, helping doctors make informed decisions for their patients.

Gender

ALL

Eligibility 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.