Acute Heart FailurePhase 2FIGHTNCT01800968
Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
A Phase 2 study testing Liraglutide in people with Acute Heart Failure, run by Duke University at 25 sites in United States.
Trial summary
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 25 sitesUnited States
- Study dates
- Apr 2013to Oct 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
- AHFS is the primary cause of hospitalization
- Prior clinical diagnosis of HF
- Left Ventricular Ejection Fraction(LVEF) ≤ 40% during the preceding 3 months (if no echo within the preceding 3 months, an LVEF ≤ 30% during the preceding three years is acceptable)
- On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant
- Use of at least 80 mg or furosemide total daily dose (or equivalent) prior to admission for AHFS (a lower dose of a loop diuretic combined with a thiazide will count as an "equivalent")
- Willingness to provide informed consent
Who cannot join
- AHFS due to acute myocarditis or acute Myocardial Infarction
- Ongoing hemodynamically significant arrhythmias contributing to HF decompensation
- Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient.
- Current or planned left ventricular assist device therapy in next 180 days
- United Network for Organ Sharing status 1A or 1B
- B-type natriuretic peptide(BNP)< 250 or NT-proBNP<1,000 (Not required per protocol but if available and too low would be an exclusion; within 48 hours of consent)
Show all 39Show fewer
- Hemoglobin (Hgb) < 8.0 g/dl
- Glomerular filtration rate(GFR) < 20 ml/min/1.73 m2 within 48 hours of consent
- Systolic blood pressure < 80 mmHg at consent
- Resting Heart Rate > 110 at consent
- Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
- Percutaneous Coronary Intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
- Primary hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy
- Constrictive pericarditis or tamponade
- Complex congenital heart disease
- Non-cardiac pulmonary edema
- More than moderate aortic or mitral stenosis
- Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
- Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
- Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, International Normalized Ration (INR) > 1.7 in the absence of anticoagulation treatment
- Terminal illness (other than HF) with expected survival of less than 1 year
- Previous adverse reaction to the study drug
- Receipt of any investigational product in the previous 30 days.
- Enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.
- Inability to comply with planned study procedures
- Pregnancy or breastfeeding mothers
- Women of reproductive age not on adequate contraception
- History of acute or chronic pancreatitis
- History of symptomatic gastroparesis
- Familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (MEN2)
- Prior weight-loss surgery (i.e., Roux-en-Y gastric bypass) or other gastric surgery associated with increased endogenous GLP-1 production
- Prior or ongoing treatment with GLP-1 receptor agonists
- Ongoing treatment with dipeptidyl peptide-IV inhibitors (1 week washout required)
- Ongoing treatment with thiazolidinedione
- Oxygen-dependent chronic obstructive pulmonary disease
- Diabetic patients with history of 2 or more severe hypoglycemia, Diabetic Ketoacidosis(DKA) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
- Diagnosis of Type 1 Diabetes Mellitus
- 40. If diabetic, inadequate glycemic control with glucose level > 300 mg/dL within 24 hours of randomization
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The University of Vermont- Fletcher Allen Health Care
Burlington, Vermont, 05401
Northwestern University
Chicago, Illinois, 60611
University Hospitals- Case Medical Center
Cleveland, Ohio, 44106
Metro Health System
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27705
Michael Debakey VA Medical Center
Houston, Texas, 77030
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, 17603
Southeast Regional Medical Center
Lumberton, North Carolina, 28538
Intermountain Medical Center
Murray, Utah, 84157
Christiana Care Health Services
Newark, Delaware, 19718
University of Pennsylvaina
Philadelphia, Pennsylvania, 19104
Jefferson Medical College
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah School of Medicine
Salt Lake City, Utah, 84132
Utah VA Medical Center
Salt Lake City, Utah, 84132
Washington University
St Louis, Missouri, 63110
Saint Louis University Hospital
St Louis, Missouri, 63117
Boston VA Healtcare System
West Roxbury, Massachusetts, 02132
About this study
Official title: Functional Impact of GLP-1 for Heart Failure Treatment
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
Read the detailed description
Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerable post-discharge period to enhance clinical stability and prevent early HF mortality and readmissions.
As heart failure (HF) progresses, impairments in metabolism render the heart substrate constrained, limiting cardiac metabolism. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin peptide that enhances cellular glucose uptake by stimulating insulin secretion and insulin sensitivity in target tissues. Preclinical and early-phase clinical data support GLP-1 as an effective therapy for advanced HF while use of GLP-1 receptor agonists in large numbers of patients with diabetes reveal a good safety profile and reductions in adverse cardiac outcomes.
- Conditions
- Acute Heart Failure
- Being tested
- Liraglutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Active Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily. Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Ranking of Predefined Events
A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.
Measured: Randomization to 180 days
Secondary outcomes (18)
Change in Left Ventricular End-Diastolic Volume Index
Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.
Measured: Baseline to 180 days
Change in Left Ventricular End-systolic Volume Index
Change in left ventricular end-systolic volume index from baseline to day 180.
Measured: Baseline to 180 days
Change in Left Ventricular Ejection Fraction
Change in left ventricular ejection fraction from baseline to day 180
Measured: Baseline to 180 days
Change in Medial Filling Pressure
Change in medial filling pressure baseline to day 180.
Measured: Baseline to 180 days
Change in Lateral Filling Pressure
Change in lateral filling pressure baseline to day 180.
Measured: Baseline to 180 days
Change in 6 Minute Walk Distance
Change in 6 minute walk distance baseline to day 30
Measured: Baseline to day 30
Change in 6 Minute Walk Distance
Change in 6 minute walk distance baseline to 90 days.
Measured: Baseline to 90 days
Change in 6 Minute Walk Distance
Change in 6 minute walk distance baseline to 180 days.
Measured: Baseline to 180 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 30 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 90 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to day 180
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 30 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 90 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 180 days
Individual Component of the Primary Endpoint- Mortality
Individual component of the primary endpoint of mortality at 180 days after randomization
Measured: Randomization to 180 days
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days
Measured: Randomization to 180 days
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days
Measured: Baseline to 180 days
Global Ranking of Predefined Events
A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.
Measured: Baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completionOct 2015
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 (4)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Adrian Hernandez, MD, Principal investigator, Duke UniversityEugene Bruanwald, MD, Study chair, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800968
- Sponsor's protocol ID
- Pro00042633
- Other IDs
- 5U10HL084904-09
- Acronym
- FIGHT
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2013
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lerman JB, Giamberardino SN, Hernandez AF, Felker GM, Shah SH, McGarrah RW. Plasma metabolites associated with functional and clinical outcomes in heart failure with reduced ejection fraction with and without type 2 diabetes. Sci Rep. 2022 Jun 2;12(1):9183. doi: 10.1038/s41598-022-12973-0.
PubMed 35654972Redouane B, Greene SJ, Fudim M, Vaduganathan M, Ambrosy AP, Sun JL, DeVore AD, McNulty SE, Mentz RJ, Hernandez AF, Felker GM, Cooper LB, Borlaug BA, Velazquez EJ, Margulies KB, Sharma A. Effects of Liraglutide on Worsening Renal Function Among Patients With Heart Failure With Reduced Ejection Fraction: Insights From the FIGHT Trial. Circ Heart Fail. 2020 May;13(5):e006758. doi: 10.1161/CIRCHEARTFAILURE.119.006758. Epub 2020 May 4.
PubMed 32362166Sharma A, Ambrosy AP, DeVore AD, Margulies KB, McNulty SE, Mentz RJ, Hernandez AF, Michael Felker G, Cooper LB, Lala A, Vader J, Groake JD, Borlaug BA, Velazquez EJ. Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial. ESC Heart Fail. 2018 Dec;5(6):1035-1043. doi: 10.1002/ehf2.12334. Epub 2018 Aug 17.
PubMed 30120812Margulies KB, Hernandez AF, Redfield MM, Givertz MM, Oliveira GH, Cole R, Mann DL, Whellan DJ, Kiernan MS, Felker GM, McNulty SE, Anstrom KJ, Shah MR, Braunwald E, Cappola TP; NHLBI Heart Failure Clinical Research Network. Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):500-8. doi: 10.1001/jama.2016.10260.
PubMed 27483064
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Impact of GLP-1 for Heart Failure Treatment
- ClinicalTrials.gov ID
- NCT01800968
- Acronym / sponsor ID
- FIGHT / Pro00042633
- Conditions
- Acute Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 15 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
Detailed description
Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerable post-discharge period to enhance clinical stability and prevent early HF mortality and readmissions.
As heart failure (HF) progresses, impairments in metabolism render the heart substrate constrained, limiting cardiac metabolism. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin peptide that enhances cellular glucose uptake by stimulating insulin secretion and insulin sensitivity in target tissues. Preclinical and early-phase clinical data support GLP-1 as an effective therapy for advanced HF while use of GLP-1 receptor agonists in large numbers of patients with diabetes reveal a good safety profile and reductions in adverse cardiac outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: LiraglutideIncreasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
- AHFS is the primary cause of hospitalization
- Prior clinical diagnosis of HF
- Left Ventricular Ejection Fraction(LVEF) ≤ 40% during the preceding 3 months (if no echo within the preceding 3 months, an LVEF ≤ 30% during the preceding three years is acceptable)
Key exclusion criteria (39 listed)
- AHFS due to acute myocarditis or acute Myocardial Infarction
- Ongoing hemodynamically significant arrhythmias contributing to HF decompensation
- Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient.
- Current or planned left ventricular assist device therapy in next 180 days
- United Network for Organ Sharing status 1A or 1B
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 |
|---|---|---|
| LiraglutideAlso: VictozaActive Drug | Drug | Liraglutide |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Global Ranking of Predefined Events
Time frame: Randomization to 180 days
A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.
18 secondary outcomes
Change in Left Ventricular End-Diastolic Volume Index
Time frame: Baseline to 180 days
Change in Left Ventricular End-systolic Volume Index
Time frame: Baseline to 180 days
Change in Left Ventricular Ejection Fraction
Time frame: Baseline to 180 days
Change in Medial Filling Pressure
Time frame: Baseline to 180 days
Change in Lateral Filling Pressure
Time frame: Baseline to 180 days
Change in 6 Minute Walk Distance
Time frame: Baseline to day 30
Change in 6 Minute Walk Distance
Time frame: Baseline to 90 days
Change in 6 Minute Walk Distance
Time frame: Baseline to 180 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline to 30 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline to 90 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline to day 180
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Baseline to 30 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Baseline to 90 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Time frame: Baseline to 180 days
Individual Component of the Primary Endpoint- Mortality
Time frame: Randomization to 180 days
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
Time frame: Randomization to 180 days
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
Time frame: Baseline to 180 days
Global Ranking of Predefined Events
Time frame: Baseline to 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35654972Lerman JB, Giamberardino SN, Hernandez AF, Felker GM, Shah SH, McGarrah RW. Plasma metabolites associated with functional and clinical outcomes in heart failure with reduced ejection fraction with and without type 2 diabetes. Sci Rep. 2022 Jun 2;12(1):9183. doi: 10.1038/s41598-022-12973-0.
- Derived from this study: PubMed 32362166Redouane B, Greene SJ, Fudim M, Vaduganathan M, Ambrosy AP, Sun JL, DeVore AD, McNulty SE, Mentz RJ, Hernandez AF, Felker GM, Cooper LB, Borlaug BA, Velazquez EJ, Margulies KB, Sharma A. Effects of Liraglutide on Worsening Renal Function Among Patients With Heart Failure With Reduced Ejection Fraction: Insights From the FIGHT Trial. Circ Heart Fail. 2020 May;13(5):e006758. doi: 10.1161/CIRCHEARTFAILURE.119.006758. Epub 2020 May 4.
- Derived from this study: PubMed 30120812Sharma A, Ambrosy AP, DeVore AD, Margulies KB, McNulty SE, Mentz RJ, Hernandez AF, Michael Felker G, Cooper LB, Lala A, Vader J, Groake JD, Borlaug BA, Velazquez EJ. Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial. ESC Heart Fail. 2018 Dec;5(6):1035-1043. doi: 10.1002/ehf2.12334. Epub 2018 Aug 17.
- Derived from this study: PubMed 27483064Margulies KB, Hernandez AF, Redfield MM, Givertz MM, Oliveira GH, Cole R, Mann DL, Whellan DJ, Kiernan MS, Felker GM, McNulty SE, Anstrom KJ, Shah MR, Braunwald E, Cappola TP; NHLBI Heart Failure Clinical Research Network. Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):500-8. doi: 10.1001/jama.2016.10260.
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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.
Adrian Hernandez, MD principal investigator
Duke University
Eugene Bruanwald, MD study chair
Harvard University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide in people with Acute Heart Failure, run by Duke University at 25 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 8 inclusion and 39 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 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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.
What does this 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.
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 15 Feb 2017). 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?
Global Ranking of Predefined Events (time frame: Randomization to 180 days). 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 NCT01800968, which also lists 4 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 15 Feb 2017.