Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

NCT05002075 | Completed DMC

• 1 other identifier: STU-2021-0329
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden and is projected to be the predominant subtype of HF in the near future. While multiple therapies have proven efficacious for patients with HFrEF, no pharmacological agents have demonstrably been shown to improve outcomes in HFpEF, highlighting the need for novel approaches to HFpEF treatment. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. Home-based exercise using an m-Health platform is an alternative to supervised exercise that can deliver clinician prescribed exercise interventions and wellness education though monitoring and care coordination. The goal of this study is to evaluate the feasibility and efficacy of a patient specific progressive home-based cardiac rehabilitation program leveraging the technology of the m-Health program in improving functional status, exercise capacity, and QOL in patients with HFpEF.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

HFpEF; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from baseline Standard physical performance battery score at 3 and 6 months

  SPPB score is a well-validated measure of physical function using 3 components: 4-m gait speed, time to complete 5 chair rises, and standing balance. Each component is scored on a 0-4 scale and summed for an overall score range of 0-12.

  3 months and 6 months

Secondary Outcomes (3)

• Peak VO2

  6 months

• 6-minute walk distance

  3 months and 6 months

• Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score

  3 months and 6 months

Study Arms (2)

Usual care arm

NO INTERVENTION

Participants in the usual control group will receive standard of care per their providers' discretion.

m-health cardiac rehabilitation intervention arm

EXPERIMENTAL

Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program

Other: m-health cardiac rehabilitation

Interventions

m-health cardiac rehabilitation OTHER

Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program delivered via a previously validated, commercially available smartphone platform called Movn (Moving Analytics, California). This app includes a patient-facing iOS and Android compatible smartphone app and an integrated hospital-facing online dashboard for remote monitoring and care coordination by a trained coach

m-health cardiac rehabilitation intervention arm

Eligibility Criteria

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

You may qualify if:

• Adults age\> 18 years
• HFpEF with left ventricular ejection fraction \>50%
• Clinically stable and no hospitalization in last 4 weeks
• Estimated glomerular filtration rate \> 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
• Stable diuretic regimen
• SPPB \<10 or historical (within 12 months) or current Peak (measured or estimated) VO2 \<= 60% predicted value for age and gender.

You may not qualify if:

• History of cancer or end stage lung disease
• Estimated glomerular filtration rate \< 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
• Recent HF decompensation
• Inability to do exercise test
• Inability to provide written informed consent
• History of falls

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (11)

• Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9. doi: 10.1161/01.cir.0000035653.72855.bf.

  PMID: 12390947 BACKGROUND

• Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.

  PMID: 21073363 BACKGROUND

• McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

  PMID: 25176015 BACKGROUND

• McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

  PMID: 31535829 BACKGROUND

• Lam CSP, Voors AA, de Boer RA, Solomon SD, van Veldhuisen DJ. Heart failure with preserved ejection fraction: from mechanisms to therapies. Eur Heart J. 2018 Aug 7;39(30):2780-2792. doi: 10.1093/eurheartj/ehy301.

  PMID: 29905796 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

  PMID: 23747642 BACKGROUND

• Pina IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, Fletcher BJ, Fleg JL, Myers JN, Sullivan MJ; American Heart Association Committee on exercise, rehabilitation, and prevention. Exercise and heart failure: A statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation. 2003 Mar 4;107(8):1210-25. doi: 10.1161/01.cir.0000055013.92097.40. No abstract available.

  PMID: 12615804 BACKGROUND

• Pandey A, MacNamara J, Sarma S, Velasco F, Kannan V, Willard J, Skinner C, Keller T, Basit M, Levine B, Willett D. Rapid-Cycle Implementation of a Multi-Organization Registry for Heart Failure with Preserved Ejection Fraction Using Health Information Exchange Standards. Stud Health Technol Inform. 2019 Aug 21;264:1560-1561. doi: 10.3233/SHTI190534.

  PMID: 31438231 BACKGROUND

• Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.

  PMID: 23877260 BACKGROUND

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

  PMID: 25559473 BACKGROUND

• Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.

  PMID: 27037982 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 12, 2021
• Study Start: November 20, 2021
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)