Who may be eligible for the CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study trial?

Inclusion Criteria: * Age \> 18 * New York Heart Association (NYHA) Class I-III Heart Failure * Able to Exercise * On stable treatment for their cardiac amyloidosis or under active surveillance * Life expectancy of at least 6 months * Ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities * Participant must be able and willing to follow the cardiac rehabilitation activities Exclusion Criteria: * Inability to provide informed consent * Inability to commit to in-person supervised exercise sessions for three one-hour sessions a week for 12 weeks * NYHA Class IV Heart Failure * Pulmonary disease requiring home oxygen * Gait instability or history of prior falls * In the opinion of the Principal Investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.

ClinicalTrials.gov record NCT06096675

CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This pilot randomized study tests supervised cardiac rehabilitation in people with cardiac amyloidosis. The rehab group is planned to attend three one-hour supervised sessions per week for 12 weeks (planned 36 sessions); the control group receives no intervention. All participants have baseline and follow-up 6-minute walk tests and cardiopulmonary exercise tests (CPET); the primary outcome is feasibility at week 12, defined as completing at least 75% of prescribed sessions.

What it is studying. The study is testing whether supervised cardiac rehabilitation can be delivered to people with cardiac amyloidosis (feasibility) and measures how cardiorespiratory fitness, ventilatory efficiency, exercise capacity, chronotropic response, and quality-of-life scores change over 12 weeks compared with no intervention.

What the researchers hope to learn. Scientific goals: assess feasibility of supervised cardiac rehabilitation in cardiac amyloidosis (completion ≥75% of sessions) and measure changes at week 12 in maximal VO2, ventilatory efficiency (VE/VCO2), Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, chronotropic incompetence, and 6-minute walk distance.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness and quality of life.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral: • Cardiac Rehabilitation

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Age > 18
New York Heart Association (NYHA) Class I-III Heart Failure
Able to Exercise
On stable treatment for their cardiac amyloidosis or under active surveillance
Life expectancy of at least 6 months
Ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities
Participant must be able and willing to follow the cardiac rehabilitation activities

Exclusion criteria

Inability to provide informed consent
Inability to commit to in-person supervised exercise sessions for three one-hour sessions a week for 12 weeks
NYHA Class IV Heart Failure
Pulmonary disease requiring home oxygen
Gait instability or history of prior falls
In the opinion of the Principal Investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The Atrium Health cardiac rehabilitation program delivers a comprehensive approach to improve cardiac performance including supervised exercise programs and has the ideal infrastructure to offer cardio-oncology rehabilitation (CORE) to all our cancer patients in the future. Currently neither CORE nor cardiac rehabilitation for HFpEF are covered by insurance, and hence the targeting of a higher risk cancer and non-cancer population of cardiac amyloidosis patients to objectively measure the benefits of a supervised exercise program ultimately to expand eligibility to all cancer patients and shape the treatment and payor landscape in the future.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

All participants will have baseline fitness tests: a 6‑minute walk test and a cardiopulmonary exercise test (CPET). Those randomized to the cardiac rehabilitation group will attend supervised exercise sessions three one‑hour times per week for 12 weeks (planned 36 sessions) and will have a repeat 6‑minute walk test and CPET within two weeks after finishing. Those randomized to the control group will have the baseline 6‑minute walk test and CPET and repeat those tests at about 12–14 weeks. Participants will also complete quality-of-life questionnaires (Kansas City Cardiomyopathy Questionnaire) and the study will record fitness measures such as maximal VO2, ventilatory efficiency (VE/VCO2), chronotropic response, and 6‑minute walk distance.

How the study is structured. Randomized, parallel-group interventional trial with no masking. Participants are assigned to either a supervised cardiac rehabilitation program (three one-hour sessions per week for 12 weeks, planned 36 sessions) or to a no-intervention control. Both groups have baseline 6-minute walk tests and CPET; the rehab group has repeat tests within 2 weeks after the 12-week program and the control group repeats testing at 12–14 weeks. The main measured outcome is feasibility at week 12 (completion of ≥75% of sessions).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jan 22, 2024
Primary completion: December 2027 (estimated)
Study completion: December 2027 (estimated)
Target enrollment: 50 participants (estimated)
Last updated on registry: Jul 21, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Wake Forest University Health Sciences

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Dana B Amaro, RN 📞 704-355-4692 ✉ Dana.Amaro@atriumhealth.org

Participating sites (1)

Sanger Heart and Vascular InstituteRecruiting
Charlotte, North Carolina, 28204 · United States
- Dana B Amaro, RN · 704-355-4692 · Dana.Amaro@atriumhealth.org
- Jai Singh, MD

Terms used on this page · explanations by MedicalUpdates.ai

Life expectancy: Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Principal Investigator: The doctor or scientist responsible for running the study at a site or overall.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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