Heart Failure, Diastolic
Conditions
Brief summary
Half of heart failure patients have preserved ejection fraction (HFpEF). Like patients with reduced ejection fraction (HFrEF), HFpEF patients suffer from exercise intolerance (low VO2max), which reduces physical function, quality of life, and survival. Strikingly, there is no medication proven to increase survival for HFpEF patients. Whereas exercise intolerance in HFrEF patients is the result of cardiovascular limitations, physical dysfunction in HFpEF patients is largely the result of peripheral abnormalities in skeletal muscle. Indeed, research in HFpEF patients identified that physical function and VO2peak are directly related to leg lean mass, and drugs focused on improving cardiovascular function have failed to improve VO2peak. Unfortunately, no therapy has been identified for this population that can concurrently improve cardiovascular and muscle health. The need for improved muscle therapies is reinforced by the fact that HFpEF patients are commonly older adults who are predisposed to muscle wasting. Strategic essential amino acid (EAA) ingestion has been shown to improve the adaptive response of muscle to exercise. Therefore, the investigators will determine, in HFpEF patients, the extent to which ingesting a strategic mixture of EAAs during an acute aerobic exercise training program enhances the response to this exercise strategy.
Interventions
OTHERExercise
Aerobic exercise performed 3/d per week during intervention
DIETARY_SUPPLEMENTEssential Amino Acids
Mixture of 10g of essential amino acids ingested throughout intervention
DIETARY_SUPPLEMENTPlacebo
10g of maltodextrin ingested throughout intervention
Sponsors
Mayo Clinic
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60+ years of age * Able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. * Diagnosed with HFpEF as per established echocardiographic criteria (New York Heart Association Class II-III).
Exclusion criteria
* Unstable angina, myocardial infarction in the past 4 weeks * Uncompensated heart failure * New York Heart Association class IV symptoms, complex ventricular arrhythmias, symptomatic severe aortic stenosis, acute pulmonary embolus, acute myocarditis, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, baseline blood screening abnormalities * Medication non-compliance * Medical / orthopedic conditions precluding exercise * Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise) * Subjects on anti-coagulation medication will not be eligible for the muscle biopsy procedure, but are deemed eligible for study participation if INR \< 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO2max | Change from pre to after the 4 week intervention | Change in maximal Aerobic Capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Flow-mediated Dilation | Change from pre to after the 4 week intervention | Change in blood vessel function |
| Change in Pulse wave velocity | Change from pre to after the 4 week intervention | Change in pulse wave velocity |
| Change in Diastolic Function | Change from pre to after the 4 week intervention | Change in diastolic Function |
| Change in Skeletal Muscle mRNA expression | Change from pre to after the 4 week intervention | Change in skeletal Muscle mRNA expression |
Countries
United States
Outcome results
None listed