Phase 3 Cardiomyopathy Trial, Recruiting NCT05961202 Sponsor: Tongji Hospital Condition: Cardiomyopathy
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Phase 3 Cardiomyopathy Trial, Recruiting

NCT05961202
Recruiting Phase 3

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:

  • You are between 18 and 80 years old (male or female)
  • A heart scan (echocardiogram) done within the last 30 days showed that your heart's pumping function is below normal (less than 50%)
  • You have had heart failure for more than 6 months that has not improved with standard treatments
  • Specific blood test results show elevated levels of two heart-related markers called hs-cTnI (above 26.2 pg/mL) and NT-proBNP (above 169 pg/mL)
  • You have previously been diagnosed with a serious heart inflammation condition called fulminant myocarditis
  • A heart tissue sample (biopsy) has confirmed that you have chronic inflammatory cardiomyopathy (long-term inflammation of the heart muscle)
  • Tests have shown that no cardiac viruses are currently active in your body
  • You are willing to volunteer and able to sign a written consent form

Who may not be able to join:

  • You are younger than 18 or older than 80 years old
  • You had a heart attack within the last month
  • You have had heart surgery or a stroke within the last 6 months
  • You are currently being prepared for a heart transplant
  • You have a serious heart rhythm problem, such as long QT syndrome
  • You are currently pregnant or breastfeeding
  • You have taken part in any medication clinical trial within the last 3 months
  • You have certain health conditions or allergies that make it unsafe to take prednisolone or hydroxychloroquine (the study medications), including untreated infections, poorly controlled diabetes, uncontrolled blood pressure, bone thinning, stomach ulcers, or certain abnormal blood count levels (confirm with trial site)
  • You have been diagnosed with, or are suspected of having, a systemic inflammatory disease (a condition causing widespread inflammation in the body)
  • You are considered to be critically ill or have a life expectancy of less than one year
  • You have a current problem with drug or alcohol misuse
  • You are unable to reliably take medications on a regular basis for any reason
  • You are unable to give informed consent

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86-027-6937-8422

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Tongji Hospital
Registry
ClinicalTrials.gov
Start date
1 November 2021
Est. completion
1 September 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Composite cardiovascular outcome

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