Cardiomyopathy Trial, Recruiting NCT05489549 Sponsor: University of Texas Southwestern Medical Center Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT05489549
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:

Group 1 – Carriers of a changed TTR gene (or matched non-carriers) without heart failure:

  • Men and women aged 30–80 who carry a disease-causing change in the TTR gene (or who are matched non-carriers), and who have no history of heart failure, meaning: no hospital stay for heart failure in the past 12 months, no recent blood test results showing elevated heart stress markers (BNP or NT-proBNP above certain levels), and no formal heart failure diagnosis from a doctor
  • People who have signed an informed consent form agreeing to take part

Group 2 – People with symptomatic hereditary TTR heart disease (hATTR-CA):

  • Men and women aged 30–80 who have been confirmed as having symptomatic hATTR-CA, shown by a history of heart failure — such as a hospital stay for heart failure in the past 12 months, elevated heart stress markers in recent blood tests, or a formal heart failure diagnosis from a treating doctor
  • People who have an established or suspected diagnosis of hATTR-CA confirmed either by a tissue biopsy using special staining and analysis, or by a specific type of bone scan (technetium-99m pyrophosphate or bisphosphonate scan) combined with accepted laboratory results showing no abnormal protein
  • People who have had, or are awaiting, genetic testing confirming a disease-causing change in the TTR gene
  • People who have signed an informed consent form agreeing to take part

Who may not be able to join:

Group 1 – Carriers without heart failure:

  • People with a personal or clinical history of heart failure
  • People with other known causes of heart muscle disease
  • People with a history of a different type of amyloidosis affecting the heart (light-chain cardiac amyloidosis)
  • People who have had a previous heart attack (either type: NSTEMI or STEMI)
  • People who have had a heart transplant
  • People who weigh more than 250 pounds (approximately 113 kg)
  • People whose kidneys are not working well enough (kidney function below a certain level, as measured by a blood test) (confirm with trial site)
  • People who cannot safely have a cardiac MRI scan

Group 2 – People with symptomatic hATTR-CA:

  • People with other known causes of heart muscle disease
  • People with a history of light-chain cardiac amyloidosis
  • People who have had a heart transplant
  • People who have had a liver transplant
  • People who have taken a TTR stabiliser medication (tafamidis or acoramidis) within the past 14 days, or who have ever taken a TTR silencer medication (inotersen, patisiran, or eplontersen)
  • People whose kidneys are not working well enough (kidney function below a certain level, as measured by a blood test) (confirm with trial site)

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: Justin L Grodin, MD MPH, UT Southwestern

Phone: 214-645-8040

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
21 November 2022
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

(Aim 1) Evidence of amyloid infiltration as measured by ECV; (Sub-aim 1) Δ stroke volume index (ΔSVi)

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