Heart Failure, DiastolicMAAX-HFNCT03312387
Muscle, Essential Amino Acids, and eXercise in Heart Failure
A study testing Exercise and Essential Amino Acids in people with Heart Failure, Diastolic, run by Arizona State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Exercise and Essential Amino Acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona State University
Phoenix, Arizona, 85004
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Cost-effective Strategies to Improve Rehabilitative Outcomes for Heart Failure Patients With Preserved Ejection Fraction
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
- Being tested
- Exercise, Essential Amino Acids, Placebo
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Aerobic exercise performed 3/d per week during intervention
Essential Amino AcidsDietary supplement
Mixture of 10g of essential amino acids ingested throughout intervention
PlaceboDietary supplement
10g of maltodextrin ingested throughout intervention
| Study group | Role | What they receive |
|---|---|---|
| Essential Amino Acid and Exercise | Experimental | Participants will be provided with essential amino acids during exercise training. Receives: Other: Exercise; Dietary Supplement: Essential Amino Acids |
| Placebo and Exercise | Placebo comparator | Participants will be provided with placebo supplement during exercise training. Receives: Other: Exercise; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2max
Change in maximal Aerobic Capacity
Measured: Change from pre to after the 4 week intervention
Secondary outcomes (4)
Change in Flow-mediated Dilation
Change in blood vessel function
Measured: Change from pre to after the 4 week intervention
Change in Pulse wave velocity
Change in pulse wave velocity
Measured: Change from pre to after the 4 week intervention
Change in Diastolic Function
Change in diastolic Function
Measured: Change from pre to after the 4 week intervention
Change in Skeletal Muscle mRNA expression
Change in skeletal Muscle mRNA expression
Measured: Change from pre to after the 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start19 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: There is no longer any funding to support the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Jared Dickinson, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312387
- Sponsor's protocol ID
- STUDY00004142
- Acronym
- MAAX-HF
- Status last verified
- Aug 2019
- First submitted
- 9 Oct 2017
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effective Strategies to Improve Rehabilitative Outcomes for Heart Failure Patients With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT03312387
- Acronym / sponsor ID
- MAAX-HF / STUDY00004142
- Conditions
- Heart Failure, Diastolic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is no longer any funding to support the study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential Amino Acid and Exercise | Experimental | Other: Exercise, Dietary Supplement: Essential Amino AcidsParticipants will be provided with essential amino acids during exercise training. |
| Placebo and Exercise | Placebo comparator | Other: Exercise, Dietary Supplement: PlaceboParticipants will be provided with placebo supplement during exercise training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAerobic exercise performed 3/d per week during intervention | Other | Essential Amino Acid and Exercise, Placebo and Exercise |
| Essential Amino AcidsMixture of 10g of essential amino acids ingested throughout intervention | Dietary supplement | Essential Amino Acid and Exercise |
| Placebo10g of maltodextrin ingested throughout intervention | Dietary supplement | Placebo and Exercise |
Primary outcome
Change in VO2max
Time frame: Change from pre to after the 4 week intervention
Change in maximal Aerobic Capacity
4 secondary outcomes
Change in Flow-mediated Dilation
Time frame: Change from pre to after the 4 week intervention
Change in Pulse wave velocity
Time frame: Change from pre to after the 4 week intervention
Change in Diastolic Function
Time frame: Change from pre to after the 4 week intervention
Change in Skeletal Muscle mRNA expression
Time frame: Change from pre to after the 4 week intervention
Results and safety
The study was stopped early (reason given: There is no longer any funding to support the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Essential Amino Acids in people with Heart Failure, Diastolic, run by Arizona State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: There is no longer any funding to support the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2max (time frame: Change from pre to after the 4 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.