Cardiomyopathy Trial, Recruiting NCT05650658 Sponsor: Baylor College of Medicine Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT05650658
Recruiting Not Applicable

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's pumping strength (measured as the left ventricle ejection fraction, or LVEF) has been recorded at 50% or below within the past 6 months
  • People who have had an electrical heart tracing (ECG) showing a delayed or widened electrical signal in the heart (QRS duration of 130 milliseconds or more), OR whose heart is expected to rely heavily on pacemaker pacing from the right side of the heart (more than 40% of the time), OR who already have a device in place that paces the right side of the heart more than 40% of the time
  • People who are already receiving the recommended standard medications for heart failure, OR whose doctor plans to work toward starting and adjusting those medications as much as their health allows before any procedure takes place

Who may not be able to join:

  • Women who are pregnant, currently breastfeeding, or planning to become pregnant during the trial
  • People who have blocked heart arteries and are likely to need a heart bypass operation or an artery-opening procedure (such as a stent) within the next 3 months
  • People who have had a heart attack (confirmed by enzyme blood tests) within the past 3 months
  • People who have had heart bypass surgery or an artery-opening procedure (such as balloon or stent treatment) within the past 3 months
  • People whose weakened heart muscle is caused by a temporary or reversible condition (for example, a recent viral infection of the heart)
  • People diagnosed with Chagas disease, cardiac sarcoidosis, or cardiac amyloidosis
  • People expected to need a mechanical heart pump (left ventricular assist device) or a heart transplant within 6 months
  • People with serious heart valve disease as their primary condition (for example, severe aortic stenosis)
  • People whose life expectancy is less than 12 months
  • People who have permanent brain damage caused by a pre-existing brain condition
  • People who are allergic to contrast dye used in imaging and are either unable or unwilling to take pre-treatment medications (steroids and/or an antihistamine) to manage that allergy
  • People currently taking part in another interventional heart-related clinical trial
  • People who would not be able to attend the scheduled follow-up visits required by the study
  • People who have previously had an unsuccessful attempt at implanting a biventricular pacemaker, His bundle pacing device, or left bundle branch pacing device

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Mihail G Chelu, MD, PhD, Baylor College of Medicine

Phone: 7137987291

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
13 September 2023
Est. completion
30 June 2029

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure

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