Heart FailureNCT07493915
Precision Rehabilitation for Veterans With (HFpEF)
An observational study of Heart Failure and Preserved Ejection Fraction, run by Columbia VA Health Care System at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Preserved Ejection Fraction
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 9 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient Veterans with Class 2-3 Heart Failure symptoms with EF≥50%.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia VA Health Care System
Columbia, South Carolina, 29209
Kurt Barringhaus, MD, FACC, FSCAI, 803-776-4000 ext. 54106, kurt.barringhaus@va.gov
Amy Flowers, 803-776-4000 ext. 56005, amy.flowers@va.gov
About this study
Official title: Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Read the 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.
- Conditions
- Heart Failure, Preserved Ejection Fraction
- Keywords
- heart failure, preserved ejection fraction, cardiac rehab, CPET, rehabilitation, HFpEF, veterans
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness (CRF)
Change in cardiorespiratory fitness response (>10% increase in oxygen consumption on cardiopulmonary exercise testing).
Measured: 12 Weeks
Secondary outcomes (6)
Change in Kansas City Cardiomyopathy Questionnaire 12 total score
Change in symptoms will be determined by assessing the difference in Kansas City Cardiomyopathy Questionnaire 12 total scores between baseline and exercise training program completion. The total score ranges from 0 to 100 with higher scores indicating better health and symptom status.
Measured: From patient enrollment to program completion at 12 weeks
Change in 6 Minute Walk Distance (feet)
Change in physical functioning using the 6-minute walk test. The change in 6 minute walking distance is expressed as an absolute value with longer distances indicating better health and physical functioning.
Measured: From enrollment to the end of the program at 12 Weeks
Exercise capacity
Change in exercise capacity in metabolic equivalents
Measured: From patient enrollment to program completion at 12 weeks
Myocardial stiffness
Change in LV myocardial and chamber stiffness by tissue doppler echocardiography
Measured: From patient enrollment to program completion at 12 weeks
Plasma MicroRNA
Change in plasma levels of miRs
Measured: From patient enrollment to program completion at 12 weeks
Physical Functioning
Change in physical functioning will be determined by assessing the difference in the summed score of questions 3-12 of the Short Form Survey (SF-36). The summed score ranges from 10-30 with higher scores indicating higher levels of physical functioning.
Measured: From patient enrollment to program completion at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Jun 2023
- Primary completion9 Apr 2026 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia VA Health Care System
- Sponsor type
- US federal agency
- Collaborators
- William Jennings Bryan Dorn VA Medical Center
- Responsible party
- Principal investigator, Kurt Barringhaus, MD, William Jennings Bryan Dorn VA Medical Center
- Investigators
- Kurt Barringhaus, MD, FACC, FSCAI, Principal investigator, William Jennings Bryan Dorn VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493915
- Sponsor's protocol ID
- 1699596
- Other IDs
- Facility Funds
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT07493915
- Acronym / sponsor ID
- 1699596
- Conditions
- Heart Failure, Preserved Ejection Fraction
- Keywords
- heart failure, preserved ejection fraction, cardiac rehab, CPET, rehabilitation, HFpEF, veterans
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Columbia VA Health Care SystemUS federal agency
- Collaborators
- William Jennings Bryan Dorn VA Medical Center
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 9 Apr 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient Veterans with Class 2-3 Heart Failure symptoms with EF≥50%.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiorespiratory Fitness (CRF)
Time frame: 12 Weeks
Change in cardiorespiratory fitness response (>10% increase in oxygen consumption on cardiopulmonary exercise testing).
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kurt Barringhaus, MD, FACC, FSCAI principal investigator
William Jennings Bryan Dorn VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Preserved Ejection Fraction, run by Columbia VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kurt Barringhaus, MD, FACC, FSCAI (803-776-4000 ext. 54106, kurt.barringhaus@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (CRF) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.