Cardiomyopathy Trial, Recruiting NCT02641145 Sponsor: Brigham and Women's Hospital Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT02641145
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:

  • You are older than 18 years of age
  • You have been diagnosed with light chain (AL) amyloidosis confirmed through standard blood, urine, or tissue tests
  • If you are traveling from out of town and your biopsy results are still pending, you may be able to start the study before results are confirmed (confirm with trial site)
  • You are willing and able to give your consent to participate
  • For the "Remission" group only: Your blood disease has been in deep remission for more than 1 year, with very low abnormal protein levels in your blood
  • For the "Active with exercise" group only: You are able to ride a stationary bicycle while lying on your back
  • For the "Early heart involvement" group only: Your heart wall thickness and heart function are either normal, or your heart wall is slightly thickened but your heart blood markers are normal, based on a recent heart ultrasound
  • For the "Multiple myeloma control" group only: You have been diagnosed with multiple myeloma but do NOT have amyloidosis
  • For the "Heart failure control" group only: You have been diagnosed with heart failure but do NOT have amyloidosis
  • For the "Active heart involvement" group only: You have abnormal heart stress marker levels in your blood (confirm with trial site for specific values)

Who may not be able to join:

  • Your blood pressure or circulation is currently unstable
  • Your heart failure is severe enough that you cannot lie flat for at least 1 hour
  • You have a heart condition unrelated to amyloidosis or blocked arteries, such as a leaky heart valve or an enlarged heart from another cause
  • You have significantly blocked heart arteries (more than 50% blockage in any area)
  • You have severe claustrophobia that cannot be managed even with calming medication
  • You have a metal implant in your body, such as a pacemaker or defibrillator, that is not safe for MRI scans (heart failure control group participants with MRI-safe devices may still be eligible — confirm with trial site)
  • Your kidneys are not working well enough (based on a blood test taken within 14 days of each MRI scan) — though heart failure control participants with poor kidney function may still have an MRI without the contrast dye
  • You are currently on kidney dialysis
  • You are pregnant (a urine pregnancy test will be done before certain scans if you could become pregnant)
  • You have a known allergy to any of the imaging agents used in this study (confirm with trial site for specific agent names)
  • For the "Active heart involvement" group only: You are unable to return to the study hospital for check-ups at 6 and 12 months
  • For the "Active with exercise" group only: You are unable to exercise or return to the study hospital for scans at the start of the study and at 6 months
  • For the "Early heart involvement" group only: You are unable to return to the study hospital for a 12-month check-up
  • For the gut microbiome part of the study only: You have certain other heart, bowel, or infectious conditions, have taken antibiotics or certain other medications recently, have had bowel surgery or colon cancer, have received chemotherapy, are pregnant, or are unable to mail a stool sample in the required timeframe (confirm with trial site for full details)

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 20 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: Sharmila Dorbala, MD, Brigham and Women's Hospital (AHA and NIH Studies)

Phone: 617-732-6290

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
1 April 2016
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 months; Change in Serum oxidative stress markers from baseline to 6 months and 12 months; Change in Myocardial oxidative metabolism markers from baseline to 6 months; Change in Magnetic resonance imaging markers from baseline to 6 months and 12 months

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: 20 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