Phase 4 Cardiomyopathy Trial, Recruiting NCT05569382 Sponsor: Morten Steen Kvistholm Jensen Condition: Cardiomyopathy
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Phase 4 Cardiomyopathy Trial, Recruiting

NCT05569382
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People whose heart wall has a maximum thickness of 15mm or more, where this thickening is not caused by high blood pressure, valve disease, or a storage disease, AND who also meet at least one of the following conditions:
    • Their heart failure symptoms are rated at a level of "slight" limitation or worse during everyday activities (confirm with trial site)
    • Their heart failure symptoms were at that same level before starting certain heart medications (beta-blockers or calcium channel blockers)
    • A specific heart stress marker measured in their blood (Pro-BNP or BNP) is above a certain level (confirm with trial site)
    • A type of abnormal heart rhythm (non-sustained ventricular tachycardia) has been recorded in the last 2 years

Who may not be able to join:

  • People whose heart's pumping strength is below 50%
  • People who have a certain type of blockage in the heart's outflow tract (measured at rest or during specific tests), either currently or in their history
  • People with a permanent irregular heart rhythm called atrial fibrillation
  • People with a permanent pacemaker lead in the right side of the heart
  • People who have previously had a bad reaction to Bisoprolol or Verapamil
  • People with known significant blockages in the heart's arteries (though a history of a procedure to open those arteries may still be acceptable)
  • People whose kidneys are not functioning well enough (below a certain filtering level — confirm with trial site)
  • Women under 50 who are pregnant, breastfeeding, or not using contraception
  • People with significant liver failure
  • People with severe heart valve disease
  • People with a very slow heart rate (below 40 beats per minute)
  • People with low blood pressure (systolic reading below 100 mmHg)
  • People with other serious health conditions or risks that the trial doctors consider relevant after individual assessment
  • People who are unable to understand the patient information, either due to language or intellectual reasons
  • People who are unable to complete an exercise test
  • People who cannot speak and/or understand Danish

For a sub-study involving heart imaging (cardiac MRI), additional exclusions apply:

  • People with an implanted heart defibrillator device of any kind
  • People with a pacemaker of any kind
  • People with certain metal implants that could affect image quality or pose a safety risk during the scan
  • People who are unable to cope with being inside a scanner

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 004540145482

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Morten Steen Kvistholm Jensen
Registry
ClinicalTrials.gov
Start date
10 August 2022
Est. completion
1 April 2027

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Maximal oxygen consumption (VO2 max); Left ventricular enddiastolic volume (LVvol); Incidence of non-sustained ventricular tachycardia (NSVT

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov