Cardiomyopathy Trial, Recruiting NCT03581318 Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT03581318
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:

As a healthy volunteer:

  • People aged 7 years or older who do not have a known heart or cardiovascular condition
  • People who are able to follow instructions and lie still inside an MRI scanner
  • People who are able to give written consent, or whose parent or guardian is able to give consent on their behalf
  • People who are willing to follow all study procedures and attend all scheduled appointments

As a participant with known or suspected heart disease:

  • People aged 7 years or older who have a known or suspected heart or cardiovascular condition
  • People who are able to give written consent, or whose parent or guardian is able to give consent on their behalf
  • People who are willing to follow all study procedures (including any required food restrictions) and attend all scheduled appointments

As a participant with a non-heart-related medical condition:

  • People aged 7 years or older who have a known or suspected condition affecting the brain, blood, cancer, hormones, lungs, or another non-heart-related area of the body
  • People who are able to give written consent, or whose parent or guardian is able to give consent on their behalf
  • People who are willing to follow all study procedures (including any required food restrictions) and attend all scheduled appointments

Who may not be able to join:

Healthy volunteers:

  • People who have had a significant or long-term medical condition, particularly major heart-related conditions such as a heart attack, a heart defect present from birth, or a diagnosed disease of the heart muscle
  • People whose MRI safety screening form indicates that an MRI scan may not be safe for them — this includes those with a cardiac pacemaker or implantable defibrillator (unless it is specifically labelled as MRI-safe or MRI-conditional), a brain aneurysm clip (unless MRI-safe), a nerve stimulator such as a TENS unit (unless MRI-safe), any type of ear or cochlear implant (unless MRI-safe), metal fragments in the eye, metal shrapnel or a bullet in the body (unless cleared by X-ray as MRI-safe), or any implanted device such as an insulin pump (unless labelled MRI-safe or MRI-conditional)
  • People whose kidney function test results (measured within the past two weeks) fall below a certain level — these participants may still be able to take part but would not be given the MRI contrast dye
  • People who are pregnant — pregnancy testing will be required in some cases before the scan; people who are post-menopausal or have had a surgical procedure that prevents pregnancy are exempt from this testing
  • Children and people who are breastfeeding are not given contrast dye; breastfeeding participants may still take part if they are willing to discard breast milk for 24 hours after receiving contrast (confirm with trial site)
  • Healthy volunteer children will not receive contrast dye
  • Healthy volunteers who have already had two MRI scans with contrast dye (gadolinium-based) within the past year, or whose two contrast scans were less than 18 hours apart, would not be able to have further contrast scans within that period

Participants with known or suspected heart disease:

  • People whose MRI safety screening form indicates that an MRI scan may not be safe for them (same implant and device criteria as listed above for healthy volunteers)
  • People who are pregnant (same pregnancy testing rules as above apply; post-menopausal and surgically sterilised participants are exempt)
  • People who are breastfeeding, unless they are willing to discard breast milk for 24 hours after receiving contrast dye
  • People whose kidney function test results fall below a certain level (measured within the past two weeks) — these participants may still be able to take part but would not be given contrast dye
  • People whose heart or breathing condition is considered unstable at the time of enrolment, as assessed by the enrolling doctor

Participants with a non-heart-related medical condition:

  • People whose MRI safety screening form indicates that an MRI scan may not be safe for them (same implant and device criteria as listed above)
  • People who are pregnant (same pregnancy testing rules as above apply; post-menopausal and surgically sterilised participants are exempt)
  • People who are breastfeeding and receiving contrast dye, unless they are willing to discard breast milk for 24 hours afterward
  • People whose kidney function test results fall below a certain level (measured within the past two weeks) — these participants may still be able to take part but would not be given contrast dye
  • People whose heart or breathing condition is considered unstable at the time of enrolment, as assessed by the enrolling doctor

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
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: W. Patricia Bandettini, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Phone: (301) 827-6720

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
12 July 2018
Est. completion
1 April 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Translational development of MRI sequences; Technical development of MRI sequences; Evaluating the correlation; Assesment of Gad deposition in the brain

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