ClinicalTrials.gov record NCT07835867
Individualized Exercise Training in Cardiac Amyloidosis
Graded Exercise Training for Individualized Treatment in Cardiac Amyloidosis: GET-FIT Cardiac Amyloidosis Study
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 randomized study tests a structured, individualized exercise program for people with transthyretin cardiac amyloidosis (ATTR-CM), including those receiving TTR-directed therapy. Participants are assigned to a 3-month training plan with gym access and personal training or to receive a physical activity handout; both groups get a smartwatch. The study measures exercise capacity and other health and quality-of-life outcomes at baseline and after 12 weeks.
What it is studying. The study tests whether adding an individualized, graded exercise training program to usual care (including TTR-directed therapy where applicable) changes measured exercise capacity and related outcomes, compared with providing a physical activity recommendations handout. Key measured outcomes are peak oxygen consumption (peak VO2) and ventilatory efficiency from cardiopulmonary exercise testing, plus questionnaires and physical-function tests.
What the researchers hope to learn. To learn whether a structured, individualized exercise program affects aerobic capacity (peak VO2), ventilatory efficiency (VE/VCO2 slope), health-related quality of life (SF-36, KCCQ), frailty (GFI), and physical performance (SPPB) in people with ATTR-CM.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Numerous clinical trials have demonstrated that transthyretin (TTR)-directed medical therapies can reduce the rate of functional decline in patients with transthyretin cardiac amyloidosis (ATTR-CM). However, patients treated with these therapies often experience a progressive reduction in exercise capacity despite treatment. Further, no randomized controlled trials (RCTs) have assessed the effects of exercise intervention in patients with ATTR-CM receiving TTR-directed therapy.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- Exercise Intervention
- Physical Activity Handout
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Clinical diagnosis of ATTR-cardiac amyloidosis
- Able to perform endurance and resistance exercise
- Currently on stable dose of TTR-directed therapy, if on therapy
- Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention.
- Signed informed consent indicating that the patient understands the purpose of the study, the procedures required and is willing to participate
Exclusion criteria
- Sustained ventricular arrhythmias or ICD shock within 6 months
- Severe valvular stenosis
- Pregnancy
- Recent acute coronary syndrome or coronary artery bypass < 6 months
- Large pericardial effusion
- Recent acute myocarditis (< 3 months)
- Recent cardiac medication changes for management of cardiomyopathy
- Patients with investigational intracardiac devices
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Habitual exercise has been shown to improve longevity and reduce overall mortality. Patients with ATTR-CM routinely experience reduced exercise tolerance and functional capacity as the disease progresses. Cardiopulmonary exercise testing (CPET) is the gold standard for assessing quantitative exercise capacity and cardiorespiratory fitness in clinical testing, and peak oxygen consumption (peak VO2) serves as one of the most powerful prognostic markers in cardiovascular health. Lower peak VO2 values are strongly correlated with adverse cardiac events and mortality in individuals with ATTR-CM, including those on contemporary therapies. While major RCTs assessing TTR silencers and stabilizers have shown a reduction in the rate of decline of functional capacity compared to placebo, patients on active therapy still experience an overall decline in functional status. Existing clinical trials have not investigated the effects of a structured exercise training protocol on preventing this functional decline in patients with ATTR-CM. This study aims to evaluate whether an individualized exercise regimen provides additive improvements in exercise capacity and quality of life for patients with ATTR-CM who are receiving background TTR-directed therapy.
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.
You will be randomly assigned to one of two groups: an intervention group that follows a 3-month individualized exercise plan with a gym membership, weekly personal training sessions, and a Garmin Forerunner 55 smartwatch; or a control group that receives an American Heart Association physical activity handout and a Garmin Forerunner 55 smartwatch. You will have cardiopulmonary exercise testing (CPET) at baseline and again at 12 weeks to measure peak VO2 and ventilatory efficiency. You will complete health and quality-of-life questionnaires (SF-36, Kansas City Cardiomyopathy Questionnaire, Groningen Frailty Indicator) and a physical function test (Short Physical Performance Battery) at the same visits. The registry record does not give further details about visit schedules, safety monitoring, or other procedures.
How the study is structured. This is a randomized, parallel-group interventional trial with single masking. Participants are randomly assigned to one of two groups for a 3-month (12-week) period: (1) an exercise intervention group that receives a 3-month training plan, gym membership, weekly personal training sessions, and a Garmin Forerunner 55 smartwatch; or (2) a control group that receives an American Heart Association Physical Activity Recommendations handout and the same smartwatch. Cardiopulmonary exercise testing (CPET) is done at baseline and at 12 weeks to measure peak VO2 and VE/VCO2 slope; other questionnaires and performance tests are collected at the same time points.
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 registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- 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.
Important dates
- Study start
- Sep 15, 2026 (estimated)
- Primary completion
- Jul 30, 2028 (estimated)
- Study completion
- September 2028 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Sep 23, 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
- Oregon Health and Science University
- Principal investigator
- Bradley Petek, Principal Investigator
Oregon Health and Science University
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.
- Bradley J Petek, MD 📞 503-494-6813 ✉ petek@ohsu.edu
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- stable dose
- A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
- 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.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- 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.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
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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