Muscle Blood Flow Regulation in HFpEF
ConditionHFpEF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older and able to give written informed consent
New York Heart Association (NYHA) functional class II or III
Left Ventricular Ejection Fraction (LVEF) > 50%
Plasma Brain Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP 400 pg/mL at enrollment
Disqualifiers
Prior EF of <50%.
NYHA Class IV or HF that cannot be stabilized on optimized pharmacotherapy
Acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis
Patients with HFpEF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction)
Trial design
Design model
Single group
Treatments tested in this trial
Exercise training
Other interventionPatients with HFpEF will undergo 8 weeks of exercise training.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Exercise trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Six-minute walk test
The six-minute walk test is used to measure distance covered during walking at a comfortable speed for six minutes
Time frame
Change from baseline six-minute walk test distance at 8 weeks2
Muscle blood flow
Muscle blood flow will be assessed non-invasively via Doppler ultrasound
Time frame
Change from baseline skeletal muscle blood flow at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov