The effect of Bisoprolol and Verapamil in non-obstructive hypertrophic cardiomyopathy

Phase 1

• Conditions: on-obstructive Hypertrophic cardiomyopathy; MedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10049813Term: Non-obstructive cardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 27.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: LLTClassification code 10061029Term: Cardiomyopathy primarySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-006953-77-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-31
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified