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
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Among 95 studies in Heart Failure, Diastolic with a site in United States — 18 open to participants now, 20 under way, none of them phase 3. Heart Failure, Diastolic · United States.
Among the 95 studies in Heart Failure, Diastolic with a site in United States, this one is the 77th largest by enrollment of the 81 interventional ones that give a count, is one of 4 that started in 2017, is one of 40 with no phase, and was the 47th registered.
199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.
Browse Heart Failure, Diastolic studies →18 of the 95 studies in Heart Failure, Diastolic with a site in United States are open now. Recruiting first, the newest first:
Tufts Medical Center · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Columbia University · Sites in United States
Ages 40+
University of Virginia · Sites in United States
Ages 18–90
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Diastolic studies recruiting now, 21 (72%) set no upper age limit and 4 (14%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
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95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 15 · Phase 3 4 · Phase 4 17
First in 2003; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1 is below the median of 48 across 139 interventional studies indexed under Heart Failure, Diastolic.
Median enrollment 36 across the 81 interventional studies, 80 across the 14 observational. Of the 70 that completed or were terminated, 34 (49%) have results posted.
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17 of 95 have an industry lead sponsor. The 10 most frequent:
Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
Arizona State University has 2 studies filed under Heart Failure, Diastolic — fewer than ten, so there is no comparison to draw.
6 of the studies in Heart Failure, Diastolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT05585125Weill Medical College of Cornell UniversityA Preliminary Study for INFORMED | 2027-02 |
| NCT06937320Duke UniversityChronic Exogenous Ketosis in HFpEF | 2027-06 |
| NCT05425459Corvia MedicalRESPONDER-HF Trial | 2027-07 |
| NCT07057323Mayo ClinicCoronary Sinus Reducer For The Management Of Symptomatic Heart Failure | 2027-08 |
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Among the 95 studies in Heart Failure, Diastolic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be provided with essential amino acids during exercise training.
Other: Exercise · Dietary Supplement: Essential Amino Acids
Participants will be provided with placebo supplement during exercise training.
Other: Exercise · Dietary Supplement: Placebo
Aerobic exercise performed 3/d per week during intervention
Mixture of 10g of essential amino acids ingested throughout intervention
10g of maltodextrin ingested throughout intervention
Change in VO2max
Change in maximal Aerobic Capacity
Time frame: Change from pre to after the 4 week intervention
Change in Flow-mediated Dilation
Change in blood vessel function
Time frame: Change from pre to after the 4 week intervention
Change in Pulse wave velocity
Change in pulse wave velocity
Time frame: Change from pre to after the 4 week intervention
Change in Diastolic Function
Change in diastolic Function
Time frame: Change from pre to after the 4 week intervention
Change in Skeletal Muscle mRNA expression
Change in skeletal Muscle mRNA expression
Time frame: Change from pre to after the 4 week intervention
Ran from Sep 2017 to primary completion in Dec 2018, 15 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Essential amino acid