Phase 3 Cardiomyopathy Trial, Recruiting NCT05321875 Sponsor: Cristina Avendaño Solá Condition: Cardiomyopathy
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Phase 3 Cardiomyopathy Trial, Recruiting

NCT05321875
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:

  • People aged 18 to 64 years (any sex) who carry a gene variant known or likely to cause dilated cardiomyopathy (a condition where the heart muscle weakens and enlarges), as confirmed using recognised genetic classification guidelines.
  • People whose heart pumping function is at or above 50%, as measured by a heart MRI scan and reviewed by the trial's eligibility committee — including those who show some scarring in the heart muscle detected on MRI.
  • People whose kidney function and blood chemical levels (specifically creatinine, potassium, and a kidney filtering rate called eGFR) are within acceptable ranges on blood tests.
  • People who are able to understand the study requirements and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

  • People with low blood pressure (a top reading below 100 mmHg, measured using a standard method).
  • People who have previously had reduced heart pumping function (below 50%) at any point before joining the trial.
  • People who are expected or very likely to need an implantable heart shock device (ICD) within 12 months of joining.
  • People who have high blood pressure that already requires medication to manage it.
  • People with persistently high blood pressure readings (top reading repeatedly above 140 mmHg) that is not well controlled.
  • People who carry a specific type of gene variant called a TTN-truncating variant and are under 35 years old.
  • People with a known significant blockage in the heart's arteries, moderate or severe heart valve disease, or serious irregular heart rhythms coming from the lower chambers of the heart.
  • People currently taking certain heart or blood pressure medications, specifically ACE inhibitors, ARBs, ARNIs, or MRAs (confirm specific medication names with the trial site).
  • People who have previously had a bad reaction or intolerance to ACE inhibitor or ARB medications.
  • People who have a medical reason why they cannot take the study drug candesartan, including severe liver failure or a bile flow problem called cholestasis.
  • People with a known blockage in the arteries supplying both kidneys.
  • People with another serious uncontrolled illness that may affect their ability to complete the full study follow-up period.
  • People who have taken part in another clinical trial involving an experimental medicine or device in the 30 days before joining this study.
  • People who are currently pregnant or breastfeeding, or people of childbearing potential who are not willing to use reliable contraception for the entire duration of the study (a negative pregnancy test is required at enrolment).
  • People who currently have a problem with drug or alcohol misuse.
  • People who are unable to follow the study procedures and treatment requirements.
  • People who have a device inside their body that is not compatible with MRI scans (such as certain ICDs, pacemakers, or aneurysm clips), who have a known intolerance to MRI scans, or who have any other reason they cannot safely have a cardiac MRI.
  • People for whom the trial investigators have any other concern that may affect safe participation in the trial.

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 22 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

Principal Investigator: Pablo García-Pavía, MD, PhD, Hospital Universitario Puerta de Hierro Majadahonda

Phone: +34 91 1916479

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
Cristina Avendaño Solá
Registry
ClinicalTrials.gov
Start date
2 June 2022
Est. completion
2 June 2026

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI

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: 22 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