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

RecruitingPhase 4Ages 18 Years - anyAllMorten Steen Kvistholm Jensen
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In plain words

What the trial is, and whether it could suit you

Aim: to compare the treatment effects of Bisoprolol (beta 1 receptor specific beta blocker (BB)) and Verapamil (cardio-specific calcium channel blockers (CCB)) in patients with non-obstructive hypertrophic cardiomyopathy (HCM). Background: Hypertrophic cardiomyopathy (HCM) is characterized by hypertrophy of the left ventricular wall and a hypercontracted state of the sarcomeres. This narrows the left ventricular cavity, but though the left ejection fraction is increased the stroke volume and the cardiac output cannot be fully compensated. The disease manifestations can be mild or develop into severe functional limitations and devastating complications at early age. Dyspnea, chest pain, palpitations and syncope are the most common symptoms, and patients are at risk of supraventricular and ventricular arrhythmias. Arrhythmias and sudden cardiac deaths may precede heart failure symptoms. P

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years * Maximal wall thickness โ‰ฅ 15 mm unrelated to hypertension, valve diseases or storage diseases. And one of the following: 1. New York Heart Association - functional class (NYHA) โ‰ฅ II 2. A history of NYHA class โ‰ฅ 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, โ‰ฅ3 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.
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What it tests

  • Verapamil
  • Bisoprolol
  • Placebo
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Where

4 sites
Department of Cardiology, Aarhus University Hospital
Aarhus N, Denmark
Department of Cardiology, Odense University Hospital
Odense, Denmark
Department of Cardiology, Zealand University Hospital
Roskilde, Denmark
Department of Cardiology, Regional Hospital Viborg
Viborg, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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