Recruiting

Monitored Exercise

Sponsor:

Columbia VA Health Care System

Code:

NCT07493915

Conditions

Heart Failure

Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Heart Failure

Preserved Ejection Fraction

Study ID

NCT07493915

Start date

Jun 1, 2023

Status verified date

Mar, 2026

Completion date

Oct 9, 2026

Anticipated

Primary completion date

Apr 9, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Cardiorespiratory Fitness (CRF) [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Kurt Barringhaus, MD, FACC, FSCAI

803-776-4000kurt.barringhaus@va.gov

Amy Flowers

80-776-4000amy.flowers@va.gov

Locations

Columbia VA Health Care System

Recruiting

Columbia, South Carolina, United States, 29209

Contacts

Kurt Barringhaus, MD, FACC, FSCAI

803-776-4000kurt.barringhaus@va.gov

Amy Flowers

803-776-4000amy.flowers@va.gov

Principal Investigator:

Kurt Barringhaus, MD, FACC, FSCAI

More Information

Sponsor

Columbia VA Health Care System

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • heart failure
  • preserved ejection fraction
  • cardiac rehab
  • CPET
  • rehabilitation
  • HFpEF
  • veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia VA Health Care System on 2026-03-25.