Individualized Exercise Training in Cardiac Amyloidosis

NCT07835867 | Not Yet Recruiting

• 1 other identifier: 29820_2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Cardiac Amyloidosis

Keywords

Cardiac Amyloidosis; Exercise Intervention; TTR-Directed Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (4)

• Short Form - 36 (SF-36)

  12 weeks

• Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)

  12 weeks

• Groningen Frailty Indicator (GFI)

  12 weeks

• Short Physical Performance Battery (SPPB)

  12 weeks

Study Arms (2)

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.

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.

Behavioral: Physical Activity Handout

Interventions

Exercise Intervention BEHAVIORAL

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.

Intervention Arm

Physical Activity Handout BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (9)

• 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.

  PMID: 30145929 BACKGROUND

• Fontana 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.

  PMID: 39213194 BACKGROUND

• Gillmore 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.

  PMID: 38197816 BACKGROUND

• Dalia 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.

  PMID: 34280522 BACKGROUND

• Patel 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.

  PMID: 38446436 BACKGROUND

• Cantone 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.

  PMID: 37264762 BACKGROUND

• Nicol 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.

  PMID: 33006180 BACKGROUND

• Kokkinos 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.

  PMID: 35926933 BACKGROUND

• Ross 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.

  PMID: 27881567 BACKGROUND

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

Bradley J Petek, MD

CONTACT

503-494-6813; petek@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL