Actively Recruiting

Age: 18Years +
All Genders
NCT07493915

Precision Rehabilitation for Veterans With (HFpEF)

Led by Columbia VA Health Care System · Updated on 2026-03-25

4

Participants Needed

1

Research Sites

175 weeks

Total Duration

On this page

Sponsors

C

Columbia VA Health Care System

Lead Sponsor

W

William Jennings Bryan Dorn VA Medical Center

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Precision Rehabilitation for Veterans With (HFpEF)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • New York Heart Association Class II or III heart failure symptoms
  • History of hypertension
  • Ejection fraction 50% or higher
  • Left ventricular hypertrophy confirmed by echocardiography, cardiac CT, or cardiac MRI
  • Diastolic dysfunction meeting at least two of the following: average E/e' >14, septal e' <7 cm/s or lateral e' <10 cm/s, tricuspid regurgitation velocity >2.8 m/s, left atrial volume index >34 mL/m2, or elevated pulmonary capillary wedge pressure or left ventricular end-diastolic pressure >15
  • Ability to participate in an exercise program as determined by a healthcare provider
Not Eligible

You will not qualify if you...

  • Ejection fraction less than 50%
  • No left ventricular hypertrophy
  • Left ventricular dilation (end diastolic volume indexed to body surface area >75 ml/m2)
  • Any segmental wall motion abnormality
  • Acute ST segment elevation myocardial infarction (STEMI)
  • Significant valvular or other non-coronary heart disease
  • Non-cardiac diseases affecting heart function (e.g., collagen-vascular disease, cardiotoxic cancer chemotherapy history, amyloid)
  • Anemia (hemoglobin <11.0 g/dl for males, <10 g/dl for females)
  • Recent unstable or accelerating angina, angina at rest, or non-ST elevation myocardial infarction within 3 months
  • Chronic lung disease requiring home oxygen or steroid therapy
  • Severe non-cardiovascular organ disease such as chronic liver or kidney disease with low kidney function (eGFR <25 mL/min/1.73m2)
  • Inability to provide informed consent
  • Inability to perform exercise

AI-Screening

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Trial Site Locations

Total: 1 location

1

Columbia VA Health Care System

Columbia, South Carolina, United States, 29209

Actively Recruiting

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Research Team

K

Kurt Barringhaus, MD, FACC, FSCAI

CONTACT

A

Amy Flowers

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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