Heart FailurePhase 2/3GLUTFISH-HFNCT01534663

Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure

A Phase 2/3 study testing Glutamine and Fish Oil Supplementation in people with Heart Failure, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Heart Failure
What is being tested?: Glutamine and Fish Oil Supplementation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited States
Study dates: Nov 2011to Jul 2014
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age greater than 18 years,
left ventricular ejection fraction less than or equal to 35%,
stable on standard HF medications, and
optimal medical therapy.

Who cannot join

major cardiovascular events,
procedures in the last 6 months,
dementia,
presence of cardiovascular diseases that may lead to harm if the patient took part in the study (congenital heart disease, long QT syndrome, hypertrophic cardiomyopathy, active myocarditis).

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF)

The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.

Conditions: Heart Failure
Being tested: Glutamine and Fish Oil Supplementation, Placebo
Keywords: Heart Failure, Skeletal Muscle Function, Metabolism, Inflammation, Glutamine, Fish oil, Muscle Function
Medical subject headings: Heart Failure, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glutamine and Fish Oil SupplementationDrug
This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.
PlaceboDrug
This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.

Study groups in NCT01534663
Study group	Role	What they receive
Placebo	Placebo comparator	The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. Receives: Drug: Placebo
Glutamine/Fishoil	Active comparator	3.285 g of EPA and 3.285 g of Docosahexaenoic acid (DHA) and L-alanyl-glutamine (8g/d). Receives: Drug: Glutamine and Fish Oil Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
Measured: Baseline
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
Measured: 90 Days
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: Baseline
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: 90 Days
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: Baseline
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: 90 Days
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: Baseline
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: 90 Days
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: Baseline
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: 90 Days
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: Baseline
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Measured: 90 Days
Percent Change in Peak Effort Oxygen Consumption
Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET).
Measured: Baseline to 90 Days

Secondary outcomes (2)

Baseline Systemic and Local Inflammation
Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Measured: Baseline
90 Day Systemic and Local Inflammation
Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jul 2014

First posted17 Feb 2012 (estimated)
Study startNov 2011
Primary completionJul 2013
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Columbia 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01534663
Sponsor's protocol ID: AAAE8356
Acronym: GLUTFISH-HF
Status last verified: Nov 2020
First submitted: 14 Feb 2012
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shahzad K, Chokshi A, Schulze PC. Supplementation of glutamine and omega-3 polyunsaturated fatty acids as a novel therapeutic intervention targeting metabolic dysfunction and exercise intolerance in patients with heart failure. Curr Clin Pharmacol. 2011 Nov;6(4):288-94. doi: 10.2174/157488411798375958.
PubMed 22082326
Wu C, Kato TS, Ji R, Zizola C, Brunjes DL, Deng Y, Akashi H, Armstrong HF, Kennel PJ, Thomas T, Forman DE, Hall J, Chokshi A, Bartels MN, Mancini D, Seres D, Schulze PC. Supplementation of l-Alanyl-l-Glutamine and Fish Oil Improves Body Composition and Quality of Life in Patients With Chronic Heart Failure. Circ Heart Fail. 2015 Nov;8(6):1077-87. doi: 10.1161/CIRCHEARTFAILURE.115.002073. Epub 2015 Aug 12.
PubMed 26269566

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF)
ClinicalTrials.gov ID: NCT01534663
Acronym / sponsor ID: GLUTFISH-HF / AAAE8356
Conditions: Heart Failure
Keywords: Heart Failure, Skeletal Muscle Function, Metabolism, Inflammation, Glutamine, Fish oil, Muscle Function
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: Nov 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2014 (actual)
First posted: 17 Feb 2012 (estimated)
Results: Posted 22 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboThe placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.
Glutamine/Fishoil	Active comparator	Drug: Glutamine and Fish Oil Supplementation3.285 g of EPA and 3.285 g of Docosahexaenoic acid (DHA) and L-alanyl-glutamine (8g/d).

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

age greater than 18 years,
left ventricular ejection fraction less than or equal to 35%,
stable on standard HF medications, and
optimal medical therapy.

Key exclusion criteria (4 listed)

major cardiovascular events,
procedures in the last 6 months,
dementia,
presence of cardiovascular diseases that may lead to harm if the patient took part in the study (congenital heart disease, long QT syndrome, hypertrophic cardiomyopathy, active myocarditis).

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
Glutamine and Fish Oil SupplementationThis is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.	Drug	Glutamine/Fishoil
PlaceboThis is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.	Drug	Placebo

Primary outcome

Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Time frame: Baseline
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Time frame: 90 Days
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Time frame: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Time frame: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Time frame: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Time frame: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Time frame: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Time frame: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Time frame: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Time frame: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Time frame: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Time frame: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Percent Change in Peak Effort Oxygen Consumption
Time frame: Baseline to 90 Days
Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET).

2 secondary outcomes

Baseline Systemic and Local Inflammation
Time frame: Baseline
90 Day Systemic and Local Inflammation
Time frame: 90 Days

Results and safety

Results posted to the registry on 22 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	14	12
Glutamine/Fishoil	17	14

Primary outcome: Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)

Time frame: Baseline. Mean (Standard Deviation). Unit: Percent

Measure	Placebo n = 12	Glutamine/Fishoil n = 14
Knee: Extension	177 (18)	196 (10)
Knee: Flexion	76 (6)	90 (5)
Elbow: Extension	65 (6)	59 (4)
Elbow: Flexion	74 (7)	71 (4)

Primary outcome: 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)

Time frame: 90 Days. Mean (Standard Deviation). Unit: Percent

Measure	Placebo n = 12	Glutamine/Fishoil n = 14
Knee: Extension	200 (20)	206 (11)
Knee: Flexion	90 (8)	90 (5)
Elbow: Extension	64 (6)	61 (4)
Elbow: Flexion	74 (6)	74 (4)

Primary outcome: Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)

Time frame: Baseline. Mean (Standard Deviation). Unit: Percent

Measure	Placebo n = 12	Glutamine/Fishoil n = 14
Knee: Extension, 5 repetitions	147 (17)	153 (8)
Knee: Flexion, 5 repetitions	61 (6)	70 (5)
Elbow: Extension, 5 repetitions	46 (5)	42 (3)
Elbow: Flexion, 5 repetitions	61 (6)	54 (3)
Knee: Extension, 25 repetitions	103 (10)	105 (7)
Knee: Flexion, 25 repetitions	55 (5)	96 (33)
Elbow: Extension, 25 repetitions	37 (3)	35 (2)
Elbow: Flexion, 25 repetitions	56 (5)	50 (3)

Primary outcome: 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)

Time frame: 90 Days. Mean (Standard Deviation). Unit: Percent

Measure	Placebo n = 12	Glutamine/Fishoil n = 14
Knee: Extension, 5 repetitions	173 (20)	160 (9)
Knee: Flexion, 5 repetitions	76 (9)	77 (4)
Elbow: Extension, 5 repetitions	48 (5)	46 (2)
Elbow: Flexion, 5 repetitions	56 (4)	57 (3)
Knee: Extension, 25 repetitions	115 (10)	108 (6)
Knee: Flexion, 25 repetitions	58 (4)	67 (3)
Elbow: Extension, 25 repetitions	38 (4)	36 (2)
Elbow: Flexion, 25 repetitions	55 (4)	51 (3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Glutamine/Fishoil	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22082326Shahzad K, Chokshi A, Schulze PC. Supplementation of glutamine and omega-3 polyunsaturated fatty acids as a novel therapeutic intervention targeting metabolic dysfunction and exercise intolerance in patients with heart failure. Curr Clin Pharmacol. 2011 Nov;6(4):288-94. doi: 10.2174/157488411798375958.
Derived from this study: PubMed 26269566Wu C, Kato TS, Ji R, Zizola C, Brunjes DL, Deng Y, Akashi H, Armstrong HF, Kennel PJ, Thomas T, Forman DE, Hall J, Chokshi A, Bartels MN, Mancini D, Seres D, Schulze PC. Supplementation of l-Alanyl-l-Glutamine and Fish Oil Improves Body Composition and Quality of Life in Patients With Chronic Heart Failure. Circ Heart Fail. 2015 Nov;8(6):1077-87. doi: 10.1161/CIRCHEARTFAILURE.115.002073. Epub 2015 Aug 12.

Related trials for Heart Failure

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A Study of Bimagrumab in Participants With HFpEF
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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.

Paolo C. Colombo, MD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Glutamine and Fish Oil Supplementation in people with Heart Failure, run by Columbia University at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534663, which also lists 2 linked publications.

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 22 Dec 2020.