NCT07493915 Precision Rehabilitation for Veterans With (HFpEF)
| NCT ID | NCT07493915 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia VA Health Care System |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 4 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-04-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4 participants in total. It began in 2023-06-01 with a primary completion date of 2026-04-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Kurt Barringhaus, MD, FACC, FSCAI
PRINCIPAL INVESTIGATOR
William Jennings Bryan Dorn VA Medical Center
Frequently Asked Questions
Who can join the NCT07493915 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07493915 currently recruiting?
Yes, NCT07493915 is actively recruiting participants. Contact the research team at kurt.barringhaus@va.gov for enrollment information.
Where is the NCT07493915 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT07493915 clinical trial?
NCT07493915 is sponsored by Columbia VA Health Care System. The principal investigator is Kurt Barringhaus, MD, FACC, FSCAI at William Jennings Bryan Dorn VA Medical Center. The trial plans to enroll 4 participants.
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