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Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT) (FIGHT)

14 febbraio 2017 aggiornato da: Duke University

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

300

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Delaware
      • Newark, Delaware, Stati Uniti, 19718
        • Christiana Care Health Services
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts Medical Center
      • West Roxbury, Massachusetts, Stati Uniti, 02132
        • Boston VA Healtcare System
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, Stati Uniti, 63110
        • Washington University
      • St. Louis, Missouri, Stati Uniti, 63117
        • Saint Louis University Hospital
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27705
        • Duke University
      • Lumberton, North Carolina, Stati Uniti, 28538
        • Southeast Regional Medical Center
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Stati Uniti, 44109
        • Metro Health System
      • Cleveland, Ohio, Stati Uniti, 44106
        • University Hospitals- Case Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, Stati Uniti, 17603
        • Lancaster Heart and Stroke Foundation
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Jefferson Medical College
      • Philadelphia, Pennsylvania, Stati Uniti, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvaina
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Michael DeBakey VA Medical Center
    • Utah
      • Murray, Utah, Stati Uniti, 84157
        • Intermountain Medical Center
      • Salt Lake City, Utah, Stati Uniti, 84132
        • University of Utah School of Medicine
      • Salt Lake City, Utah, Stati Uniti, 84132
        • Utah VA Medical Center
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05401
        • The University of Vermont- Fletcher Allen Health Care

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Age ≥ 18 years
  2. 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)
  3. AHFS is the primary cause of hospitalization
  4. Prior clinical diagnosis of HF
  5. 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)
  6. On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant
  7. 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")
  8. Willingness to provide informed consent

Exclusion Criteria:

  1. AHFS due to acute myocarditis or acute Myocardial Infarction
  2. Ongoing hemodynamically significant arrhythmias contributing to HF decompensation
  3. Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient.
  4. Current or planned left ventricular assist device therapy in next 180 days
  5. United Network for Organ Sharing status 1A or 1B
  6. 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)
  7. Hemoglobin (Hgb) < 8.0 g/dl
  8. Glomerular filtration rate(GFR) < 20 ml/min/1.73 m2 within 48 hours of consent
  9. Systolic blood pressure < 80 mmHg at consent
  10. Resting Heart Rate > 110 at consent
  11. 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)
  12. Percutaneous Coronary Intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
  13. Primary hypertrophic cardiomyopathy
  14. Infiltrative cardiomyopathy
  15. Constrictive pericarditis or tamponade
  16. Complex congenital heart disease
  17. Non-cardiac pulmonary edema
  18. More than moderate aortic or mitral stenosis
  19. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
  20. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
  21. 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
  22. Terminal illness (other than HF) with expected survival of less than 1 year
  23. Previous adverse reaction to the study drug
  24. Receipt of any investigational product in the previous 30 days.
  25. Enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.
  26. Inability to comply with planned study procedures
  27. Pregnancy or breastfeeding mothers
  28. Women of reproductive age not on adequate contraception
  29. History of acute or chronic pancreatitis
  30. History of symptomatic gastroparesis
  31. Familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (MEN2)
  32. Prior weight-loss surgery (i.e., Roux-en-Y gastric bypass) or other gastric surgery associated with increased endogenous GLP-1 production
  33. Prior or ongoing treatment with GLP-1 receptor agonists
  34. Ongoing treatment with dipeptidyl peptide-IV inhibitors (1 week washout required)
  35. Ongoing treatment with thiazolidinedione
  36. Oxygen-dependent chronic obstructive pulmonary disease
  37. Diabetic patients with history of 2 or more severe hypoglycemia, Diabetic Ketoacidosis(DKA) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
  38. Diagnosis of Type 1 Diabetes Mellitus

40. If diabetic, inadequate glycemic control with glucose level > 300 mg/dL within 24 hours of randomization

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Liraglutide
Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily.
Droga: Liraglutide
Active Drug
Altri nomi:
  • Vittoria
Comparatore placebo: Placebo
Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily.
Droga: Placebo
Placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Global Ranking of Predefined Events
Lasso di tempo: 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.
Randomization to 180 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Left Ventricular End-Diastolic Volume Index
Lasso di tempo: Baseline to 180 days
Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.
Baseline to 180 days
Change in Left Ventricular End-systolic Volume Index
Lasso di tempo: Baseline to 180 days
Change in left ventricular end-systolic volume index from baseline to day 180.
Baseline to 180 days
Change in Left Ventricular Ejection Fraction
Lasso di tempo: Baseline to 180 days
Change in left ventricular ejection fraction from baseline to day 180
Baseline to 180 days
Change in Medial Filling Pressure
Lasso di tempo: Baseline to 180 days
Change in medial filling pressure baseline to day 180.
Baseline to 180 days
Change in Lateral Filling Pressure
Lasso di tempo: Baseline to 180 days
Change in lateral filling pressure baseline to day 180.
Baseline to 180 days
Change in 6 Minute Walk Distance
Lasso di tempo: Baseline to day 30
Change in 6 minute walk distance baseline to day 30
Baseline to day 30
Change in 6 Minute Walk Distance
Lasso di tempo: Baseline to 90 days
Change in 6 minute walk distance baseline to 90 days.
Baseline to 90 days
Change in 6 Minute Walk Distance
Lasso di tempo: Baseline to 180 days
Change in 6 minute walk distance baseline to 180 days.
Baseline to 180 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Lasso di tempo: Baseline to 30 days
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.
Baseline to 30 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Lasso di tempo: Baseline to 90 days
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.
Baseline to 90 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Lasso di tempo: Baseline to day 180
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.
Baseline to day 180
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Lasso di tempo: Baseline to 30 days
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.
Baseline to 30 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Lasso di tempo: Baseline to 90 days
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.
Baseline to 90 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Lasso di tempo: Baseline to 180 days
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.
Baseline to 180 days
Individual Component of the Primary Endpoint- Mortality
Lasso di tempo: Randomization to 180 days
Individual component of the primary endpoint of mortality at 180 days after randomization
Randomization to 180 days
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
Lasso di tempo: Randomization to 180 days
Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days
Randomization to 180 days
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
Lasso di tempo: Baseline to 180 days
Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days
Baseline to 180 days
Global Ranking of Predefined Events
Lasso di tempo: Baseline to 180 days
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.
Baseline to 180 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Duke University

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Investigatori

  • Cattedra di studio: Eugene Bruanwald, MD, Harvard University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2013

Completamento primario (Effettivo)

1 ottobre 2015

Completamento dello studio (Effettivo)

1 ottobre 2015

Date di iscrizione allo studio

Primo inviato

7 febbraio 2013

Primo inviato che soddisfa i criteri di controllo qualità

26 febbraio 2013

Primo Inserito (Stima)

28 febbraio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 febbraio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 febbraio 2017

Ultimo verificato

1 febbraio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00042633
  • 5U10HL084904-09 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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