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New treatment option for Non-obstructive Hypertrophic Cardiomyopathy
Official title Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy
ClinicalTrials.gov ID: NCT05569382
What this study is testing
What is Verapamil?
Verapamil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-obstructive hypertrophic cardiomyopathy.
Also referred to as Isoptin Retard 240 MG, Verapamil Hydrochloride 240 MG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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:
- New York Heart Association - functional class (NYHA) ≥ II
- A history of NYHA class ≥ II before treatment with BB or CCB
- Pro-BNP\>300 ng/l/35\>nmol/l or BNP \>100ng/l/\>29nmol/l
You likely can't join if
- 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)
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:
- New York Heart Association - functional class (NYHA) ≥ II
- A history of NYHA class ≥ II before treatment with BB or CCB
- Pro-BNP\>300 ng/l/35\>nmol/l or BNP \>100ng/l/\>29nmol/l
- Non-sustained VT (\>120 min-1, ≥3 cycles) documented within the last 2 years of screening
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
- Odense, Denmark
- Roskilde, Denmark
- Viborg, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark; Odense, Denmark; Roskilde, Denmark; Viborg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.