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TerminatedNCT03312387MAAX-HFUpdated Sep 3, 2019

Muscle, Essential Amino Acids, and eXercise in Heart Failure

An interventional study of Exercise and Essential Amino Acids in Heart Failure, Diastolic, sponsored by Arizona State University. Terminated at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-09-03.

Sponsored by Arizona State University · Not applicable, Interventional, and Other

Why this study was terminated
There is no longer any funding to support the study
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure, Diastolic
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Essential Amino Acid and Exercise

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

    Other: Exercise · Dietary Supplement: Essential Amino Acids

  • Placebo comparator
    Placebo and Exercise

    Participants will be provided with placebo supplement during exercise training.

    Other: Exercise · Dietary Supplement: Placebo

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

05

What researchers measure

Primary outcomes

  1. Change in VO2max

    Change in maximal Aerobic Capacity

    Time frame: Change from pre to after the 4 week intervention

Secondary outcomes

  1. Change in Flow-mediated Dilation

    Change in blood vessel function

    Time frame: Change from pre to after the 4 week intervention

  2. Change in Pulse wave velocity

    Change in pulse wave velocity

    Time frame: Change from pre to after the 4 week intervention

  3. Change in Diastolic Function

    Change in diastolic Function

    Time frame: Change from pre to after the 4 week intervention

  4. Change in Skeletal Muscle mRNA expression

    Change in skeletal Muscle mRNA expression

    Time frame: Change from pre to after the 4 week intervention

06

Study locations

2 sites
  • Arizona State University
    Phoenix, Arizona 85004, United States
  • Mayo Clinic Arizona
    Scottsdale, Arizona 85259, United States
07

Registry details

Key details

Study ID
NCT03312387
Lead sponsor
Arizona State University
Collaborators
Mayo Clinic
Responsible party
Jared Dickinson (Assistant Professor, Arizona State University) — Principal investigator
First posted
Oct 17, 2017
Start date
Sep 19, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Sep 3, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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