NCT07493915 · Columbia VA Health Care System
Precision Rehabilitation for Veterans With (HFpEF)
What this study is about
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).
View original scientific description
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.
Primary outcome measures
Cardiorespiratory Fitness (CRF)
Time frame: 12 Weeks
Change in cardiorespiratory fitness response (\>10% increase in oxygen consumption on cardiopulmonary exercise testing).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- New York Heart Association Class II or III HF symptoms
- History of hypertension
- 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
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
Where
- Columbia, South Carolina
Collaborators
William Jennings Bryan Dorn VA Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations