Muscle, Essential Amino Acids, and eXercise in Heart Failure

NCT ID: NCT03312387

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2018-12-31

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.

Conditions

Heart Failure, Diastolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Essential Amino Acid and Exercise

Participants will be provided with essential amino acids during exercise training.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Aerobic exercise performed 3/d per week during intervention

Essential Amino Acids

Intervention Type: DIETARY_SUPPLEMENT

Mixture of 10g of essential amino acids ingested throughout intervention

Placebo and Exercise

Participants will be provided with placebo supplement during exercise training.

Group Type: PLACEBO_COMPARATOR

Exercise

Intervention Type: OTHER

Aerobic exercise performed 3/d per week during intervention

Placebo

Intervention Type: DIETARY_SUPPLEMENT

10g of maltodextrin ingested throughout intervention

Interventions

Exercise

Aerobic exercise performed 3/d per week during intervention

Intervention Type: OTHER

Essential Amino Acids

Mixture of 10g of essential amino acids ingested throughout intervention

Intervention Type: DIETARY_SUPPLEMENT

Placebo

10g of maltodextrin ingested throughout intervention

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Jared Dickinson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Phoenix, Arizona, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

STUDY00004142

Identifier Type: -

Identifier Source: org_study_id