Cardiac AmyloidosisGET-FIT ATTRNCT07835867
Individualized Exercise Training in Cardiac Amyloidosis
A study testing Exercise Intervention and Physical Activity Handout in people with Cardiac Amyloidosis, run by Oregon Health and Science University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Exercise Intervention and Physical Activity Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Graded Exercise Training for Individualized Treatment in Cardiac Amyloidosis: GET-FIT Cardiac Amyloidosis Study
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.
Read the detailed description
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.
- Conditions
- Cardiac Amyloidosis
- Being tested
- Exercise Intervention, Physical Activity Handout
- Keywords
- Cardiac Amyloidosis, Exercise Intervention, TTR-Directed Therapy
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
A 3-month training plan with a gym membership including weekly personal training sessions. Subjects will also be given a Garmin Forerunner 55 smartwatch to exercise.
Physical Activity HandoutBehavioural
An American Heart Association Physical Activity Recommendations handout will be provided, and a Garmin Forerunner 55 smartwatch will be given to subjects to wear during waking hours over a 3-month period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants randomized to the intervention arm will be prescribed a training plan and provided with a gym membership including personal training sessions. Participants will also be given a smartwatch to track activity. Receives: Behavioral: Exercise Intervention |
| Control Arm | Active comparator | Participants randomized to the control arm will receive a Physical Activity Recommendations Handout and a smartwatch to track activity. Receives: Behavioral: Physical Activity Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption (Peak VO2)
CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.
Measured: 12 weeks
Ventilatory Efficiency (VE/VCO2 Slope)
Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.
Measured: 12 weeks
Secondary outcomes (4)
Short Form - 36 (SF-36)
The SF-36 is a general health survey to assess overall physical and mental health domains. Scores on each scale range from 0 to 100, with higher scores representing better health-related quality of life and health status.
Measured: 12 weeks
Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)
Quality of life questionnaire scaled from 0 to 100, where higher scores indicate better health status. This will be recorded at baseline and 12-weeks. An increase of 5 points is considered a clinically meaningful increase.
Measured: 12 weeks
Groningen Frailty Indicator (GFI)
The GFI is a 15-item self-report questionnaire used to determine overall frailty level across physical, cognitive, social, and psychological domains. Scores range from 0 to 15, with higher scores representing greater degrees of frailty.
Measured: 12 weeks
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is a standardized performance-based assessment of lower-extremity physical function in older adults. It consists of three components: standing balance, usual gait speed, and repeated chair-stand performance. Each component is scored from 0 to 4 points, for a total score ranging from 0 to 12, with higher scores indicating better physical function.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Petek, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835867
- Sponsor's protocol ID
- 29820_2
- Acronym
- GET-FIT ATTR
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A limited access dataset generated from this project will rapidly be made available to the broader community for distribution to outside researchers according to established Oregon Health \& Science University policies. Exercise training plans developed as part of the study will be made available.
Publications
Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
PubMed 30145929Fontana M, Berk JL, Gillmore JD, Witteles RM, Grogan M, Drachman B, Damy T, Garcia-Pavia P, Taubel J, Solomon SD, Sheikh FH, Tahara N, Gonzalez-Costello J, Tsujita K, Morbach C, Pozsonyi Z, Petrie MC, Delgado D, Van der Meer P, Jabbour A, Bondue A, Kim D, Azevedo O, Hvitfeldt Poulsen S, Yilmaz A, Jankowska EA, Algalarrondo V, Slugg A, Garg PP, Boyle KL, Yureneva E, Silliman N, Yang L, Chen J, Eraly SA, Vest J, Maurer MS; HELIOS-B Trial Investigators. Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy. N Engl J Med. 2025 Jan 2;392(1):33-44. doi: 10.1056/NEJMoa2409134. Epub 2024 Aug 30.
PubMed 39213194Gillmore JD, Judge DP, Cappelli F, Fontana M, Garcia-Pavia P, Gibbs S, Grogan M, Hanna M, Hoffman J, Masri A, Maurer MS, Nativi-Nicolau J, Obici L, Poulsen SH, Rockhold F, Shah KB, Soman P, Garg J, Chiswell K, Xu H, Cao X, Lystig T, Sinha U, Fox JC; ATTRibute-CM Investigators. Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2024 Jan 11;390(2):132-142. doi: 10.1056/NEJMoa2305434.
PubMed 38197816Dalia T, Acharya P, Chan WC, Sauer AJ, Weidling R, Fritzlen J, Goyal A, Miller D, Knipper E, Porter CB, Shah Z. Prognostic Role of Cardiopulmonary Exercise Testing in Wild-Type Transthyretin Amyloid Cardiomyopathy Patients Treated With Tafamidis. J Card Fail. 2021 Nov;27(11):1285-1289. doi: 10.1016/j.cardfail.2021.06.022. Epub 2021 Jul 16.
PubMed 34280522Patel RK, Bandera F, Venneri L, Porcari A, Razvi Y, Ioannou A, Chacko L, Martinez-Naharro A, Rauf MU, Knight D, Brown J, Petrie A, Wechalekar A, Whelan C, Lachmann H, Muthurangu V, Guazzi M, Hawkins PN, Gillmore JD, Fontana M. Cardiopulmonary Exercise Testing in Evaluating Transthyretin Amyloidosis. JAMA Cardiol. 2024 Apr 1;9(4):367-376. doi: 10.1001/jamacardio.2024.0022.
PubMed 38446436Cantone A, Serenelli M, Sanguettoli F, Maio D, Fabbri G, Dal Passo B, Agostoni P, Grazzi G, Campo G, Rapezzi C. Cardiopulmonary exercise testing predicts prognosis in amyloid cardiomyopathy: a systematic review and meta-analysis. ESC Heart Fail. 2023 Aug;10(4):2740-2744. doi: 10.1002/ehf2.14406. Epub 2023 Jun 1.
PubMed 37264762Nicol M, Deney A, Lairez O, Vergaro G, Emdin M, Carecci A, Inamo J, Montfort A, Neviere R, Damy T, Harel S, Royer B, Baudet M, Cohen-Solal A, Arnulf B, Logeart D. Prognostic value of cardiopulmonary exercise testing in cardiac amyloidosis. Eur J Heart Fail. 2021 Feb;23(2):231-239. doi: 10.1002/ejhf.2016. Epub 2020 Oct 22.
PubMed 33006180Kokkinos P, Faselis C, Samuel IBH, Pittaras A, Doumas M, Murphy R, Heimall MS, Sui X, Zhang J, Myers J. Cardiorespiratory Fitness and Mortality Risk Across the Spectra of Age, Race, and Sex. J Am Coll Cardiol. 2022 Aug 9;80(6):598-609. doi: 10.1016/j.jacc.2022.05.031.
PubMed 35926933Ross R, Blair SN, Arena R, Church TS, Despres JP, Franklin BA, Haskell WL, Kaminsky LA, Levine BD, Lavie CJ, Myers J, Niebauer J, Sallis R, Sawada SS, Sui X, Wisloff U; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Cardiovascular and Stroke Nursing; Council on Functional Genomics and Translational Biology; Stroke Council. Importance of Assessing Cardiorespiratory Fitness in Clinical Practice: A Case for Fitness as a Clinical Vital Sign: A Scientific Statement From the American Heart Association. Circulation. 2016 Dec 13;134(24):e653-e699. doi: 10.1161/CIR.0000000000000461. Epub 2016 Nov 21.
PubMed 27881567