Precision Rehabilitation for Veterans With (HFpEF)

NCT07493915 | Recruiting

• 2 other identifiers: 1699596Facility Funds
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Preserved Ejection Fraction

Keywords

heart failure; preserved ejection fraction; cardiac rehab; CPET; rehabilitation; HFpEF; veterans

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness (CRF)

  Change in cardiorespiratory fitness response (\>10% increase in oxygen consumption on cardiopulmonary exercise testing).

  12 Weeks

Secondary Outcomes (6)

• Change in Kansas City Cardiomyopathy Questionnaire 12 total score

  From patient enrollment to program completion at 12 weeks

• Change in 6 Minute Walk Distance (feet)

  From enrollment to the end of the program at 12 Weeks

• Exercise capacity

  From patient enrollment to program completion at 12 weeks

• Myocardial stiffness

  From patient enrollment to program completion at 12 weeks

• Plasma MicroRNA

  From patient enrollment to program completion at 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia VA Health Care System: lead
• William Jennings Bryan Dorn VA Medical Center: collaborator

Study Sites (1)

Columbia VA Health Care System

Columbia, South Carolina, 29209, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Frozen blood plasma specimens

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kurt Barringhaus, MD, FACC, FSCAI

  William Jennings Bryan Dorn VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Barringhaus, MD, FACC, FSCAI

CONTACT

803-776-4000; kurt.barringhaus@va.gov

Amy Flowers

CONTACT

80-776-4000; amy.flowers@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Laboratory at WJB Dorn VAMC, Columbia, SC and PRISMA Health-Midlands, Columbia, SC; Clinical Associate Professor of Medicine, Cardiovascular Division, Palmetto Health-University of South Carolina, Columbia, SC

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: March 25, 2026
• Study Start: June 1, 2023
• Primary Completion: April 9, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)