- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002075
Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Approximately 6.2 million adults in the United States suffer from heart failure (HF), of which almost one-half maintain a left ventricle ejection fraction (EF) >50% known as heart failure with preserved ejection fraction (HFpEF). The prevalence of HFpEF has been increasing as compared with HF with reduced ejection fraction (HFrEF) over time, particularly in older adults. HFpEF is associated with a high morbidity and mortality burden and remains recalcitrant to available pharmacotherapies, significantly highlighting the need for novel strategies for management. Emerging data suggests HFpEF is a multiorgan disease with complex pathophysiology culminating in debilitating exercise intolerance (EI). This key clinical manifestation of HFpEF, stems from multiple causal pathways: accelerated fitness decline with aging, high comorbidity burden, sarcopenia, impaired cardiovascular reserve, and skeletal muscle myopathy. EI demonstrated by dyspnea and fatigue cascades into functional deconditioning and reduced quality of life (QOL). In addition to EI, >90% of patients with HFpEF are pre-frail or frail and demonstrate physical function limitations. Unfortunately, these characteristic clinical findings in HFpEF are strongly predictive of death and hospitalization. There is an urgent need to develop effective therapeutic approaches targeting EI and physical function to achieve meaningful improvements in patient-reported and clinical outcomes in HFpEF.
Supervised exercise training has been shown to improve functional status, exercise capacity, quality of life (QOL), and lower risk of hospitalization in patients with HF with most studies conducted in the HFrEF population. Smaller trials have demonstrated significant improvements in exercise capacity and QOL with supervised exercise training in HFpEF.5 Accordingly, the AHA/ACC 2013 HF guidelines recommend exercise and cardiac rehabilitation (CR) for patients with chronic HF who can participate in exercise to improve QOL and functional status. Furthermore, a statement from the AHA committee on exercise, rehabilitation, and prevention recommends exercise intensity, duration, and frequency should be tailored to the individual needs of patients. In 2014, HFrEF became a reimbursable diagnosis for comprehensive cardiac rehabilitation (CR) but HFpEF was excluded due to lack of large-scale clinical end-point driven trial evidence. Despite the established benefits, CR is widely underutilized with <10% of eligible HF participants engaging in the same. CR participation barriers include comprehensive institutional expertise needed, widespread regulations, low reimbursement rates, high patient cost, patient time and travel, and facility requirement. Considering the benefits effects of exercise training on patient-oriented functional outcomes in HFpEF and the lack of availability of the current supervised exercise CR model (3 times/week x 12 weeks) for this patient population, there is a need for a more feasible, scalable, and cost-effective alternative approach to delivering exercise training.
Home-based CR using a m-Health platform is a novel alternative to supervised CR that can deliver clinician specific exercise interventions and CR wellness education with remote monitoring and care coordination. The feasibility and efficacy of home-based CR among patients with HFpEF have not been evaluated but have a critical potential impact for this population. This is particularly relevant given the focus on telehealth and home-based in the era of COVID-19. This represents a significant knowledge gap and opportunity considering the current clinical reality that patients with HFpEF have a high burden of physical function impairment and exercise intolerance, the previously reported benefits of exercise training in this patient population, and the current lack of therapeutic opportunities that can be feasibly implemented on a population scale.
Home-based CR with m-health platform is not the standard of care currently, but is an exploratory intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75235
- Recruiting
- UT Southwestern Medical Center
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Sub-Investigator:
- Vinayak Subramanian, MD
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Contact:
- Ambarish Pandey, MD
- Phone Number: 214-645-9762
- Email: ambarish.pandey@utsouthwestern.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care arm
Participants in the usual control group will receive standard of care per their providers' discretion.
|
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Experimental: m-health cardiac rehabilitation intervention arm
Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Standard physical performance battery score at 3 and 6 months
Time Frame: 3 months 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak VO2
Time Frame: 6 months
|
Peak VO2 is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol
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6 months
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6-minute walk distance
Time Frame: 3 months and 6 months
|
6-MWD is a simple and well-validated measure of submaximal exercise capacity and does not require any exercise equipment or advanced training for technicians
|
3 months and 6 months
|
Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time Frame: 3 months and 6 months
|
QOL will be assessed using the KCCQ score, which is a self-administered questionnaire that assesses a patient's perception of their heart failure with regard to the psychological, physical, and socioeconomic aspects of life.
Minimum value is 0 and maximum value is 100.
Lower scores means a worse outcome
|
3 months and 6 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Eur Heart J. 2019 Feb 7;40(6):528.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2021-0329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
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University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
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University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
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Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
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Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
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Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
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Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
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Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
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Wake Forest University Health SciencesRecruitingCardiac AmyloidosisUnited States
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Cairo UniversityNational Heart Institute, EgyptCompletedChronic Heart FailureEgypt