Precision Rehabilitation for Veterans With (HFpEF)

Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)

This study is being completed because there is conflicting information regarding the value of monitored exercise in patients with heart failure with preserved ejection fraction (HFpEF). The purpose of this study is to collect baseline information necessary for researchers to pursue a larger study evaluating how monitored exercise performed during cardiac rehabilitation may improve heart health and the amount of oxygen delivered to the tissues during exercise. Researchers must first examine whether the facility is capable of supporting such a study and whether in a modest number of patients, there is no clear detrimental effect to exercise. Rather, there may be an important improvement that has been underestimated to date.

Participation will require a time commitment for performing exercise 3 times per week for 12 weeks in addition to having a small amount of blood drawn twice. There will also be a specialized form of a stress test (cardiopulmonary exercise test; "CPET") with ultrasound imaging of the heart (echocardiography) completed twice.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Preserved Ejection Fraction

Detailed Description

Small studies have suggested that supervised exercise training improves cardiorespiratory fitness (CRF) in some patients with heart failure with preserved ejection fraction (HFpEF), but the response rate to exercise is broad, and the impact of exercise on quality of life and physical functioning at the Veteran level are incompletely understood. More recently, HFpEF patients randomized to moderate levels of exercise (moderate continuous training; MCT) increased VO2Peak, the quatitative measure of CRF) but not to the very aggressive level specified by the study. As such, the findings were considered statistically insignificant. To address the clinical question utilizing accepted targets, fill the scientific gaps, and advance the understanding of how monitored exercise improves both HFpEF severity and the lives of Veterans with HFpEF, an adequately powered study is required to assess the role of MCT for improving CRF, HF symptoms, QOL, physical functioning, and myocardial structure and function. Identifying patients at baseline likely to respond to MCT is the subject of the second aim and will be important for maximizing VA resources and delivering timely and effective care to veterans with HFpEF. The investigators plan to enroll 4 patients to provide preliminary and feasibility data to refine the protocol for the intended study, a request of the review committee who have favorably scored the MERIT proposal.

The long-term strategy is to improve exercise tolerance and functional capacity of HFpEF patients by favorably altering cardiac structure and function and the microRNA signature driving myocardial fibrosis. The investigators intend to conduct a larger study to test the central hypothesis that monitored exercise training improves CRF, HF symptoms, QOL, and functional status in veterans with HFpEF and that the expression pattern of miRs critical for regulating fibrosis (miR-,-21,-29,-133) can identify HFpEF patients responsive to exercise training when integrated into a comprehensive predictive tool incorporating clinical characteristics along with sensitive echocardiographic measures of LV diastolic function. This project will provide feasibility and preliminary data in 4 patients for the future study.

• Study Type: Observational
• Enrollment (Estimated): 4

Contacts and Locations

• Study Contact: Name: Kurt Barringhaus, MD, FACC, FSCAI; Phone Number: 54106 803-776-4000; Email: kurt.barringhaus@va.gov
• Study Contact Backup: Name: Amy Flowers; Phone Number: 56006 80-776-4000; Email: amy.flowers@va.gov

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29209
      • Recruiting
      • Columbia VA Health Care System
      • Contact: Kurt Barringhaus, MD, FACC, FSCAI; Phone Number: 54106 803-776-4000; Email: kurt.barringhaus@va.gov
      • Contact: Amy Flowers; Phone Number: 56005 803-776-4000; Email: amy.flowers@va.gov
      • Principal Investigator: Kurt Barringhaus, MD, FACC, FSCAI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Outpatient Veterans with Class 2-3 Heart Failure symptoms with EF≥50%.

Description

Inclusion Criteria:

• New York Heart Association Class II or III HF symptoms
• History of hypertension
• EF≥50%
• LVH confirmed by echocardiography, Cardiac CT, or Cardiac MR

• Diastolic dysfunction which must include ≥2 of the following:

  1. Average E/e'>14
  2. Septal e'<7 cm/s or Lateral e' <10 cm/s
  3. TR velocity> 2.8 m/s
  4. LA computed volume index >34 mL/M2
  5. PCWP or LVEDP>15
• Ability to participate in an exercise program as determined by a research, cardiology, or primary care provider

Exclusion Criteria:

• Ejection Fraction < 50%
• Absence of LVH
• LV Dilation (LV end diastolic volume indexed to BSA > 75 ml/m2)
• Any Segmental wall motion abnormality
• Acute ST segment elevation myocardial infarction (STEMI)
• Significant valvular or other non-coronary heart disease
• Any non-cardiac disease or condition that could influence myocardial function (e.g., collagen-vascular disease, history of cardiotoxic cancer chemotherapy, amyloid)
• Anemia defined as Hgb < 11.0 g/dl in males, 10 g/dl in females
• Current accelerating angina, unstable angina, angina at rest, or NSTEMI within 3 months
• Chronic pulmonary disease requiring home oxygen or steroid therapy
• Significant non-CV organ disease: Chronic hepatic or renal disease (eGFR < 25 mL/min/1.73m2)
• Inability to provide informed consent
• Inability to perform exercise

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory Fitness (CRF)	Change in cardiorespiratory fitness response (>10% increase in oxygen consumption on cardiopulmonary exercise testing).	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Kansas City Cardiomyopathy Questionnaire 12 total score	Change in symptoms will be determined by assessing the difference in Kansas City Cardiomyopathy Questionnaire 12 total scores between baseline and exercise training program completion. The total score ranges from 0 to 100 with higher scores indicating better health and symptom status.	From patient enrollment to program completion at 12 weeks
Change in 6 Minute Walk Distance (feet)	Change in physical functioning using the 6-minute walk test. The change in 6 minute walking distance is expressed as an absolute value with longer distances indicating better health and physical functioning.	From enrollment to the end of the program at 12 Weeks
Exercise capacity	Change in exercise capacity in metabolic equivalents	From patient enrollment to program completion at 12 weeks
Myocardial stiffness	Change in LV myocardial and chamber stiffness by tissue doppler echocardiography	From patient enrollment to program completion at 12 weeks
Plasma MicroRNA	Change in plasma levels of miRs	From patient enrollment to program completion at 12 weeks
Physical Functioning	Change in physical functioning will be determined by assessing the difference in the summed score of questions 3-12 of the Short Form Survey (SF-36). The summed score ranges from 10-30 with higher scores indicating higher levels of physical functioning.	From patient enrollment to program completion at 12 weeks

Collaborators and Investigators

• Sponsor: Columbia VA Health Care System
• Collaborators: William Jennings Bryan Dorn VA Medical Center
• Investigators: Principal Investigator: Kurt Barringhaus, MD, FACC, FSCAI, William Jennings Bryan Dorn VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 9, 2026
• Study Completion (Estimated): October 9, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; heart failure; veterans; HFpEF; CPET; preserved ejection fraction; cardiac rehab
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 1699596; Facility Funds (Other Identifier: William Jennings Bryan DORN)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No