Precision Rehabilitation for Veterans With (HFpEF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Preserved Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)
Overview
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.
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 (moderate continuous training; MCT) increased VO2Peak, the quatitative measure of CRF) but not to the very aggressive level specified by the study. As such, the findings were considered statistically insignificant. To address the clinical question utilizing accepted targets, fill the scientific gaps, and advance the understanding of how monitored exercise improves both HFpEF severity and the lives of Veterans with HFpEF, an adequately powered study is required to assess the role of MCT for improving CRF, HF symptoms, QOL, physical functioning, and myocardial structure and function. Identifying patients at baseline likely to respond to MCT is the subject of the second aim and will be important for maximizing VA resources and delivering timely and effective care to veterans with HFpEF. The investigators plan to enroll 4 patients to provide preliminary and feasibility data to refine the protocol for the intended study, a request of the review committee who have favorably scored the MERIT proposal.
The long-term strategy is to improve exercise tolerance and functional capacity of HFpEF patients by favorably altering cardiac structure and function and the microRNA signature driving myocardial fibrosis. The investigators intend to conduct a larger study to test the central hypothesis that monitored exercise training improves CRF, HF symptoms, QOL, and functional status in veterans with HFpEF and that the expression pattern of miRs critical for regulating fibrosis (miR-,-21,-29,-133) can identify HFpEF patients responsive to exercise training when integrated into a comprehensive predictive tool incorporating clinical characteristics along with sensitive echocardiographic measures of LV diastolic function. This project will provide feasibility and preliminary data in 4 patients for the future study.
Primary outcome measures
- Cardiorespiratory Fitness (CRF) [Time frame: 12 Weeks]
Secondary outcome measures (6)
- Change in Kansas City Cardiomyopathy Questionnaire 12 total score [Time frame: From patient enrollment to program completion at 12 weeks]
- Change in 6 Minute Walk Distance (feet) [Time frame: From enrollment to the end of the program at 12 Weeks]
- Exercise capacity [Time frame: From patient enrollment to program completion at 12 weeks]
- Myocardial stiffness [Time frame: From patient enrollment to program completion at 12 weeks]
- Plasma MicroRNA [Time frame: From patient enrollment to program completion at 12 weeks]
- Physical Functioning [Time frame: From patient enrollment to program completion at 12 weeks]
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Columbia VA Health Care System — Columbia
Identifiers
NCT: NCT07493915 · 1699596 · Facility Funds