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

Aarhus University Hospital0 个研究点目标入组 140 人开始时间: 2022年1月31日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•- Informed consent
•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•- Left ventricular ejection fraction < 50%
•- LVOT gradient >30 mmHg at rest or during Valsalva maneuver after discontinuation of BB or CCB respectively
•- Previous 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.
•- 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:
•- 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.

发起方

Aarhus University Hospital