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Treatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy
EU CTIS ID: 2024-515346-17-00
What this study is testing
The overall clinical purpose and the purpose of this study is to reduce the symptomatic burden and arrhythmic complications in patients with HCM. We aim to quantify the effect of Bisoprolol and Verapamil on maximal oxygen consumption (VO2 max), left ventricular end diastolic volume and the incidence of non-sustained ventricular tachycardia in patients with non-obstructive hypertrophic cardiomyopathy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.