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

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ClinicalTrials.gov Identifier: NCT05002075
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ambarish Pandey, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Other: m-health cardiac rehabilitation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Controlled Trial
Actual Study Start Date : November 20, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual care arm
Participants in the usual control group will receive standard of care per their providers' discretion.
Experimental: m-health cardiac rehabilitation intervention arm
Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program
 Other: m-health cardiac rehabilitation
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Adults age> 18 years
  2. HFpEF with left ventricular ejection fraction >50%
  3. Clinically stable and no hospitalization in last 4 weeks
  4. Estimated glomerular filtration rate > 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
  5. Stable diuretic regimen

Exclusion criteria:

  1. History of cancer or end stage lung disease
  2. Estimated glomerular filtration rate < 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
  3. Recent HF decompensation
  4. Inability to do exercise test
  5. Inability to provide written informed consent
  6. History of falls
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05002075


Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Ambarish Pandey, MD    214-645-9762    ambarish.pandey@utsouthwestern.edu   
Sub-Investigator: Vinayak Subramanian, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
More Information
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Publications:

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Responsible Party: Ambarish Pandey, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05002075    
Other Study ID Numbers: STU-2021-0329
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ambarish Pandey, University of Texas Southwestern Medical Center:
HFpEF
Cardiac rehabilitation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases