Treatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy

Aarhus Universitetshospital0 个研究点目标入组 140 人开始时间: 2024年6月13日最近更新: 2024年7月22日

适应症

试验速览

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•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

•Left ventricular ejection fraction < 50%, Significant liver failure, severe valvular disease, bradycardia (40bpm) or 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 CMRI sub-study: 1.Implantable cardioverter defibrillator (any kind): 2.Pacemaker (any kind): 3.Metal implants like to affect image quality: 4.Metal implants that poses a risk during CMRI: 5.Inability to cope with being in the scanner., 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 anticonceptions.

发起方

Aarhus Universitetshospital