Peripheral Neuropathy Trial, Recruiting NCT05797857 Sponsor: Brigham and Women's Hospital Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT05797857
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 have been diagnosed with a heart condition called ATTR cardiac amyloidosis (ATTR-CM), confirmed either by a heart tissue biopsy or a specific type of nuclear scan showing Grade 2 or Grade 3 results.
  • You have been diagnosed with heart failure and have needed water pills (diuretics) at some point, along with an elevated level of a specific heart-related protein in your blood (BNP ≥450 pg/ml).
  • Your body's ability to use oxygen during exercise is below 80% of what would normally be expected for someone your age (this applies to one part of the study only).
  • You are currently taking a medication called tafamidis (this applies to one part of the study only).
  • You are able to walk at least 4 meters (about 13 feet), with or without a walking aid, and can manage basic daily tasks on your own.
  • Your doctor considers your condition stable enough to safely take part in the study activities.
  • You are willing to sign a consent form showing you understand the study and agree to take part.

Who may not be able to join:

  • You have recently had a heart attack.
  • You have a significant blockage (more than 70%) in the arteries that supply your heart.
  • You have a severely narrowed aortic heart valve.
  • You are already taking part in a structured, facility-based heart exercise programme.
  • You are already doing moderate to vigorous exercise for more than 30 minutes a day, at least twice a week, regularly over the past 6 weeks.
  • You have a mechanical heart pump device (ventricular assist device).
  • Your amyloidosis is caused by something other than ATTR (for example, light chain amyloidosis).
  • You have advanced kidney disease (confirm with trial site for specific test values).
  • You have had any organ transplant.
  • You have a serious illness other than heart failure, and doctors estimate you have less than 1 year to live.
  • You have a pacemaker or internal heart device with heart rate settings that cannot be adjusted to allow safe exercise.
  • You have nerve damage (neuropathy) caused by a TTR gene mutation.
  • You have a physical or medical condition from a stroke, injury, or other illness that would prevent you from taking part in exercise activities.
  • You had an abnormal result on a specific exercise breathing test (CPET) that needs further investigation before you could take part.
  • You have dementia that would prevent you from following the study's exercise programme or instructions.
  • The screening process suggests there is a high chance you would have difficulty following the study requirements.
  • You are unwilling or unable to follow the study's requirements.

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 28 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.

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
10 July 2024
Est. completion
30 June 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

peak oxygen consumption (VO2)

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: 28 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