Muscle, Essential Amino Acids, and eXercise in Heart Failure

NCT03312387 | Terminated DMC

• 1 other identifier: STUDY00004142
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in VO2max

  Change in maximal Aerobic Capacity

  Change from pre to after the 4 week intervention

Secondary Outcomes (4)

• Change in Flow-mediated Dilation

  Change from pre to after the 4 week intervention

• Change in Pulse wave velocity

  Change from pre to after the 4 week intervention

• Change in Diastolic Function

  Change from pre to after the 4 week intervention

• Change in Skeletal Muscle mRNA expression

  Change from pre to after the 4 week intervention

Study Arms (2)

Essential Amino Acid and Exercise

EXPERIMENTAL

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

Other: Exercise; Dietary Supplement: Essential Amino Acids

Placebo and Exercise

PLACEBO COMPARATOR

Participants will be provided with placebo supplement during exercise training.

Other: Exercise; Dietary Supplement: Placebo

Interventions

Exercise OTHER

Aerobic exercise performed 3/d per week during intervention

Essential Amino Acid and Exercise; Placebo and Exercise

Essential Amino Acids DIETARY_SUPPLEMENT

Mixture of 10g of essential amino acids ingested throughout intervention

Essential Amino Acid and Exercise

Placebo DIETARY_SUPPLEMENT

10g of maltodextrin ingested throughout intervention

Placebo and Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator

Study Sites (2)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Exercise; Amino Acids, Essential

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 17, 2017
• Study Start: September 19, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

US (2)