Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Heart Failure, Diastolic Clinical Trial

— CRpEF  

Official title:

Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02762825
• Other study ID #: HFHS HFpEF HIIT
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: September 27, 2022

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. NYHA class II or III symptoms

2. 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.

3. = 50 years of age

4. Free of orthopedic or other medical problems that would limit participation in CR

5. Peak VO2 on baseline cardiopulmonary exercise test (CPX) < 24 mL/kg/min in men and <21 mL/kg/min in women

Exclusion Criteria:

1. Systolic dysfunction, per ejection fraction < 50%; those with mild (grade I) diastolic dysfunction

2. 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)

3. Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing

4. Pregnant or planning to become pregnant

5. 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)

6. Atrial fibrillation

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

Behavioral:
• HIIT
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.
• MCT
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.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak oxygen consumption from baseline		Change from baseline at 10-12 weeks