Precision Rehabilitation for Veterans With (HFpEF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia VA Health Care System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
New York Heart Association Class II or III HF symptoms
History of hypertension
EF≥50%
LVH confirmed by echocardiography, Cardiac CT, or Cardiac MR
Disqualifiers
Ejection Fraction < 50%
Absence of LVH
LV Dilation (LV end diastolic volume indexed to BSA > 75 ml/m2)
Any Segmental wall motion abnormality
Trial population
Outpatient Veterans with Class 2-3 Heart Failure symptoms with EF≥50%.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cardiorespiratory Fitness (CRF)
Change in cardiorespiratory fitness response (\>10% increase in oxygen consumption on cardiopulmonary exercise testing).
Time frame
12 WeeksSecondary outcomes
1
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.
Time frame
From patient enrollment to program completion at 12 weeks2
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.
Time frame
From enrollment to the end of the program at 12 Weeks3
Exercise capacity
Change in exercise capacity in metabolic equivalents
Time frame
From patient enrollment to program completion at 12 weeks4
Myocardial stiffness
Change in LV myocardial and chamber stiffness by tissue doppler echocardiography
Time frame
From patient enrollment to program completion at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia VA Health Care System
Lead sponsor
William Jennings Bryan Dorn VA Medical Center
Sponsor institution
William Jennings Bryan Dorn VA Medical Center
Collaborator
Source ClinicalTrials.gov