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Clinical Trial NCT07493915 for Heart Failure, Preserved Ejection Fraction is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Precision Rehabilitation for Veterans With (HFpEF) 4 Veterans Exercise-Based

Recruiting
Clinical Trial NCT07493915 is an observational study for Heart Failure, Preserved Ejection Fraction that is recruiting. It started on 1 June 2023 with plans to enroll 4 participants. Led by Columbia VA Health Care System, it is expected to complete by 9 October 2026. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 oxyge...Show More
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 (...Show More
Official Title

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

Conditions
Heart FailurePreserved Ejection Fraction
Other Study IDs
  • 1699596
  • Facility Funds (Other Identifier) (William Jennings Bryan DORN)
NCT ID Number
NCT07493915
Start Date (Actual)
2023-06-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-10-09
Enrollment (Estimated)
4
Study Type
Observational
Status
Recruiting
Keywords
heart failure
preserved ejection fraction
cardiac rehab
CPET
rehabilitation
HFpEF
veterans
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cardiorespiratory Fitness (CRF)
Change in cardiorespiratory fitness response (\>10% increase in oxygen consumption on cardiopulmonary exercise testing).
12 Weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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

  • 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
Columbia VA Health Care System logoColumbia VA Health Care System
William Jennings Bryan Dorn VA Medical Center logoWilliam Jennings Bryan Dorn VA Medical Center
Study Responsible Party
Kurt Barringhaus, MD, Principal Investigator, 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, William Jennings Bryan Dorn VA Medical Center
Study Central Contact
Contact: Kurt Barringhaus, MD, FACC, FSCAI, 803-776-4000, [email protected]
Contact: Amy Flowers, 80-776-4000, [email protected]
1 Study Locations in 1 Countries

South Carolina

Columbia VA Health Care System, Columbia, South Carolina, 29209, United States
Kurt Barringhaus, MD, FACC, FSCAI, Contact, 803-776-4000, [email protected]
Amy Flowers, Contact, 803-776-4000, [email protected]
Kurt Barringhaus, MD, FACC, FSCAI, Principal Investigator
Recruiting