Precision Rehabilitation for Veterans With (HFpEF)
Recruiting · NCT07493915 · Observational (researchers observe without assigning treatment) · Lead sponsor: Columbia VA Health Care System
View the official record on ClinicalTrials.gov →What this trial 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). 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.
Who can take part
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:
- 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 it is running
1 location listed across 1 US state.
- Columbia VA Health Care System - Columbia, South Carolina, United States