Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Study Overview
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Brief Summary
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Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be consistently beneficial in treating these problems. However, increasing evidence suggests that exercise training is effective for both partially reversing exercise intolerance and improving quality of life in these patients. Most such trials to date have been conducted in controlled research setting, versus integrating these patients in to a standard CR program. Also, since functional capacity is related to outcomes in these patients, exercise strategies aimed at further improving fitness are warranted. One such strategy is using higher intensity interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with other types of CVD. This project is designed to test the feasibility of incorporating these patients into the CR setting, and training them using a methodology (i.e., HIIT) already shown to yield (in other patients with CVD) greater gains in fitness when compared to what was achieved using standard MCT alone.

Official Title
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Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Conditions
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Heart Failure, Diastolic

Intervention / Treatment
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* Behavioral: HIIT
* Behavioral: MCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA class II or III symptoms Referred by physician to CR with echocardiographic evidence of HFpEF defined as an ejection fraction ≥ 50 % and moderate to severe (grade II-III) diastolic dysfunction. ≥ 50 years of age Free of orthopedic or other medical problems that would limit participation in CR Peak VO2 on baseline cardiopulmonary exercise test (CPX) < 24 mL/kg/min in men and <21 mL/kg/min in women Exclusion Criteria: Systolic dysfunction, per ejection fraction < 50%; those with mild (grade I) diastolic dysfunction Initial clinical responses observed during first 3 visits in CR or baseline exercise test that would preclude participation in study over-all (e.g., new onset/troublesome arrhythmia that warrants further investigation) or undergoing HIIT (e.g., claudication, balance issue) Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing Pregnant or planning to become pregnant Any patient recently hospitalized for heart failure will have to wait at least 2 weeks before starting CR, or until clinically stable per physician(whichever time period is greater) Atrial fibrillation

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher Intensity Interval Training (HIIT)<br> | Behavioral: HIIT<br>* HIIT will consist of 4 min of higher intensity work set at 90% of heart rate reserve, based on peak heart rate from CPX test. Recovery intervals will be 3-4 min in duration and set at 60-70% of heart rate reserve. Resistance training will be performed once per week.<br>|
| Active Comparator: Moderate Continuous Training (MCT)<br> | Behavioral: MCT<br>* MCT will consist of aerobic exercise performed 3 times per week for 30 min each session, at an intensity of 60-80% of heart rate reserve, based on peak heart rate from CPX test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen consumption from baseline |  | Change from baseline at 10-12 weeks |