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Precision Rehabilitation for Veterans With (HFpEF)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether supervised exercise is safe and may improve heart health and oxygen delivery in veterans with HFpEF, a type of heart failure where the heart still pumps a normal share of blood. It also checks whether the center can support a larger study. Participants exercise 3 times a week for 12 weeks and have blood draws and exercise tests with heart ultrasound twice.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have heart failure symptoms that limit everyday activity somewhat or greatly (Class II or III).
  • Have a history of high blood pressure.
  • Have a heart that pumps out at least 50% of its blood with each beat.
  • Have thickened muscle in the heart’s main pumping chamber, confirmed by heart imaging.
  • Have trouble with the heart relaxing and filling, shown by at least 2 of the study’s required heart measurements.
  • Be able to join an exercise program, as judged by a research, heart care, or primary care provider.

Who can't join

  • The heart pumps out less than 50% of its blood per beat, has no thickened muscle, has an enlarged main pumping chamber by the study’s measure, or has an area that moves abnormally.
  • Have a current STEMI heart attack, or an NSTEMI heart attack within 3 months. These are different types of heart attack.
  • Have chest pain from poor heart blood flow that is worsening, unstable, or happens at rest.
  • Have major heart valve disease or other heart disease not caused by blocked heart arteries.
  • Have another illness that could affect heart muscle, such as certain immune diseases or abnormal protein buildup, or have had cancer drugs that can harm the heart.
  • Have anemia (low red blood cells), with hemoglobin below 11 g/dL in males or 10 g/dL in females.
  • Have long-term lung disease needing home oxygen or steroids, or major disease in another organ, such as long-term liver disease or kidney disease with a filtering rate below 25.
  • Cannot give informed consent to join the study or cannot exercise.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

SC