Muscle, Essential Amino Acids, and eXercise in Heart Failure

Heart Failure, Diastolic Clinical Trial

— MAAX-HF  

Official title:

Cost-effective Strategies to Improve Rehabilitative Outcomes for Heart Failure Patients With Preserved Ejection Fraction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03312387
• Other study ID #: STUDY00004142
• Status: Terminated
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

Other:
• Exercise
Aerobic exercise performed 3/d per week during intervention

Dietary Supplement:
• Essential Amino Acids
Mixture of 10g of essential amino acids ingested throughout intervention
• Placebo
10g of maltodextrin ingested throughout intervention

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VO2max	Change in maximal Aerobic Capacity	Change from pre to after the 4 week intervention
Secondary	Change in Flow-mediated Dilation	Change in blood vessel function	Change from pre to after the 4 week intervention
Secondary	Change in Pulse wave velocity	Change in pulse wave velocity	Change from pre to after the 4 week intervention
Secondary	Change in Diastolic Function	Change in diastolic Function	Change from pre to after the 4 week intervention
Secondary	Change in Skeletal Muscle mRNA expression	Change in skeletal Muscle mRNA expression	Change from pre to after the 4 week intervention