Clinical trial NCT03312387: Muscle, Essential Amino Acids, and eXercise in Heart Failure
Official title: Cost-effective Strategies to Improve Rehabilitative Outcomes for Heart Failure Patients With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure, Diastolic
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2017-10-17
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in VO2max
timeFrame: Change from pre to after the 4 week intervention
Secondary outcomes:
measure: Change in Flow-mediated Dilation
timeFrame: Change from pre to after the 4 week intervention
measure: Change in Pulse wave velocity
timeFrame: Change from pre to after the 4 week intervention
measure: Change in Diastolic Function
timeFrame: Change from pre to after the 4 week intervention
measure: Change in Skeletal Muscle mRNA expression
timeFrame: Change from pre to after the 4 week intervention
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
References: