Phase 4 Cardiomyopathy Trial, Recruiting NCT06580717 Sponsor: Yonsei University Condition: Cardiomyopathy
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Phase 4 Cardiomyopathy Trial, Recruiting

NCT06580717
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:

  • People who have read and understood the research protocol and have signed a consent form
  • Adults aged 20 to 79 years old
  • People who do not have diabetes, or people who have type 2 diabetes with a blood sugar control measure (HbA1c) between 6.5% and 10.5%
  • People diagnosed with a specific type of heart muscle condition called non-obstructive hypertrophic cardiomyopathy, where the heart wall is thickened but does not significantly block blood flow — confirmed by a heart ultrasound test within 3 months before the screening visit (confirm with trial site for exact measurements)
  • People already taking certain heart medications (such as beta-blockers, certain calcium channel blockers, water tablets, or blood pressure medicines) whose medication doses have been stable for at least 2 weeks before screening and are not expected to change during the study
  • Women of childbearing age who agree to use an approved form of contraception from 30 days before screening, throughout the trial, and for a period after the trial ends
  • People whose heart failure symptoms are rated as Class 1, 2, or 3 on a standard scale used by doctors to measure how much symptoms affect daily activity (NYHA classification)

Who may not be able to join:

  • People who have had a known allergic reaction to the study drug in the past
  • People currently taking a type of diabetes medication called SGLT2 inhibitors, or who have taken one within the past 4 weeks
  • People who are unable to undergo a specific type of heart ultrasound test that measures heart function during activity (diastolic stress echocardiography)
  • People on dialysis, or people with significantly reduced kidney function (eGFR below 30 mL/min/1.73m²)
  • People who have a device implanted in or around their heart (such as a pacemaker or defibrillator)
  • People who are currently pregnant or breastfeeding
  • People with significantly elevated liver enzyme levels on blood tests, or those with a history of liver coma, certain swollen veins in the food pipe, or a specific type of liver surgery (confirm with trial site for details)
  • People with very high blood pressure (top number at or above 180 mmHg or bottom number at or above 110 mmHg) or very low blood pressure (top number below 90 mmHg)
  • People with severe narrowing of certain heart valves (aortic or mitral) who may need surgery during the trial period
  • People who are on a waiting list for a heart transplant or who have already received a heart transplant
  • People with certain other serious conditions — such as severe anaemia, uncontrolled irregular heartbeat, or severe lung disease — that could be confused with heart failure symptoms, as determined by the study doctor
  • People currently receiving chemotherapy, radiation, or surgical treatment for cancer, or whose life expectancy is less than one year
  • People with untreated alcohol or drug dependency
  • People currently participating in another clinical trial involving a drug or device, or who finished such a trial less than 30 days ago
  • People with type 1 diabetes or a serious diabetes-related complication called diabetic ketoacidosis
  • People whose heart failure symptoms are rated as Class 4 (the most severe level) on the NYHA scale

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 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
15 October 2024
Est. completion
30 November 2026

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Change from baseline in left ventricular diastolic reserve (Δe') assessed by diastolic stress echocardiography

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: 27 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