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Muscle, Essential Amino Acids, and eXercise in Heart Failure (MAAX-HF)

Primary Purpose

Heart Failure, Diastolic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Essential Amino Acids
Placebo
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure, Diastolic

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona State University
  • Mayo Clinic Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Essential Amino Acid and Exercise

Placebo and Exercise

Arm Description

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

Participants will be provided with placebo supplement during exercise training.

Outcomes

Primary Outcome Measures

Change in VO2max
Change in maximal Aerobic Capacity

Secondary Outcome Measures

Change in Flow-mediated Dilation
Change in blood vessel function
Change in Pulse wave velocity
Change in pulse wave velocity
Change in Diastolic Function
Change in diastolic Function
Change in Skeletal Muscle mRNA expression
Change in skeletal Muscle mRNA expression

Full Information

First Posted
October 9, 2017
Last Updated
August 29, 2019
Sponsor
Arizona State University
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03312387
Brief Title
Muscle, Essential Amino Acids, and eXercise in Heart Failure
Acronym
MAAX-HF
Official Title
Cost-effective Strategies to Improve Rehabilitative Outcomes for Heart Failure Patients With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
There is no longer any funding to support the study
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Essential Amino Acid and Exercise
Arm Type
Experimental
Arm Description
Participants will be provided with essential amino acids during exercise training.
Arm Title
Placebo and Exercise
Arm Type
Placebo Comparator
Arm Description
Participants will be provided with placebo supplement during exercise training.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Aerobic exercise performed 3/d per week during intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Essential Amino Acids
Intervention Description
Mixture of 10g of essential amino acids ingested throughout intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
10g of maltodextrin ingested throughout intervention
Primary Outcome Measure Information:
Title
Change in VO2max
Description
Change in maximal Aerobic Capacity
Time Frame
Change from pre to after the 4 week intervention
Secondary Outcome Measure Information:
Title
Change in Flow-mediated Dilation
Description
Change in blood vessel function
Time Frame
Change from pre to after the 4 week intervention
Title
Change in Pulse wave velocity
Description
Change in pulse wave velocity
Time Frame
Change from pre to after the 4 week intervention
Title
Change in Diastolic Function
Description
Change in diastolic Function
Time Frame
Change from pre to after the 4 week intervention
Title
Change in Skeletal Muscle mRNA expression
Description
Change in skeletal Muscle mRNA expression
Time Frame
Change from pre to after the 4 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

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Muscle, Essential Amino Acids, and eXercise in Heart Failure

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