- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01251406
Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (ZS-01-210)
A Randomized, Parallel, Placebo-controlled, Double-blind Phase IIa Study of Efficacy and Safety of Recombinant Human Neuregulin-1 (Neucardin) in Subjects With Stable Chronic Heart Failure
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure.
A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria.
Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
California
-
La Jolla, California, États-Unis, 92037
- University of California, San Diego
-
Los Angeles, California, États-Unis, 90033
- Metabolic Clinic and Research Center
-
Los Angeles, California, États-Unis, 90033
- USC Cardiovascular Division
-
Tustin, California, États-Unis, 92780
- Orange County Research Center
-
-
Colorado
-
Denver, Colorado, États-Unis, 80045
- University of Colorado Denver
-
-
Florida
-
Clearwater, Florida, États-Unis, 33756
- Clearwater Cardiovascular & Interventional Consultants, MD, PA
-
Tampa, Florida, États-Unis, 33606
- University Of South Florida
-
-
Iowa
-
Iowa City, Iowa, États-Unis, 52242
- University of Iowa Hospitals and Clinics
-
-
Louisiana
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Kenner, Louisiana, États-Unis, 70065
- MedPharmics, LLC.
-
Metairie, Louisiana, États-Unis, 70006
- Benchmark Research
-
-
Texas
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Houston, Texas, États-Unis, 77002
- East Texas Cardiology
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Plano, Texas, États-Unis, 75075
- The Medical Center of Plano
-
-
Virginia
-
Norfolk, Virginia, États-Unis, 23507
- Sentara Cardiovascular Research Institute
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age > 18 years.
- Male or female subjects.
- Have chronic heart failure defined as NYHA classification of II or III.
- Be on a stable regimen of ACEI/ARB and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable HF medication regime throughout the duration of the trial.
- Left ventricular ejection fraction (LVEF) of < 35% as determined at screening by 2-D echocardiography.
- Is able to understand and provide informed consent.
- If subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
- Proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). Women must have a negative pregnancy test at screening.
- No greater than mild pericardial effusion < 0.5 cm on echocardiography (roughly corresponds to < 100 mL).
- Have an implantable cardioverter-defibrillator (ICD). The ICD should have been implanted at least 3 months prior to receiving study medication. Patients should undergo interrogation of their ICDs between 1 and 7 days before randomization to drug for the previous thirty (30) days. This interrogation would include surveillance for ventricular arrhythmias as well as assessment of ICD discharge(s) and/or anti-tachycardia pacing.
Exclusion Criteria:
- Has chronic heart failure classified as NYHA Class I or IV.
- Has a history of any malignancy or positive test as specified in the pre-cancer screening.
- Have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
- Has a body weight >350lbs.
- Has had any cause hospitalization 30 days prior to screening.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Daily subcutaneous administration for 8 hours a day for 10 days
Autres noms:
|
Expérimental: rhNRG-1 Dose 1
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Daily subcutaneous administration for 8 hours a day for 10 days
Autres noms:
|
Expérimental: rhNRG-1 Dose 2
Subcutaneous administration for 8 hours a day for 10 days
|
Daily subcutaneous administration for 8 hours a day for 10 days
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline in LVEF
Délai: 30 days
|
Compared to baseline and placebo
|
30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Six (6) minute walk test
Délai: Day 30, 90, 180, 365
|
Compared to baseline and placebo
|
Day 30, 90, 180, 365
|
Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire)
Délai: Day 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Day 30, 90, 180 and 365
|
NYHA class status
Délai: Day 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Day 30, 90, 180 and 365
|
All cause mortality and all cause hospitalization
Délai: Days 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Days 30, 90, 180 and 365
|
Change in LVESV and LVEDV
Délai: Day 30
|
Compared to baseline and placebo
|
Day 30
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Barry Greenberg, MD, University of California, San Diego
- Chercheur principal: Uri Elkayam, MD, LAC+USC Medical Center
Publications et liens utiles
Publications générales
- Xu Y, Li X, Liu X, Zhou M. Neuregulin-1/ErbB signaling and chronic heart failure. Adv Pharmacol. 2010;59:31-51. doi: 10.1016/S1054-3589(10)59002-1.
- Jabbour A, Hayward CS, Keogh AM, Kotlyar E, McCrohon JA, England JF, Amor R, Liu X, Li XY, Zhou MD, Graham RM, Macdonald PS. Parenteral administration of recombinant human neuregulin-1 to patients with stable chronic heart failure produces favourable acute and chronic haemodynamic responses. Eur J Heart Fail. 2011 Jan;13(1):83-92. doi: 10.1093/eurjhf/hfq152. Epub 2010 Sep 1.
- Gao R, Zhang J, Cheng L, Wu X, Dong W, Yang X, Li T, Liu X, Xu Y, Li X, Zhou M. A Phase II, randomized, double-blind, multicenter, based on standard therapy, placebo-controlled study of the efficacy and safety of recombinant human neuregulin-1 in patients with chronic heart failure. J Am Coll Cardiol. 2010 May 4;55(18):1907-14. doi: 10.1016/j.jacc.2009.12.044.
- Liu X, Gu X, Li Z, Li X, Li H, Chang J, Chen P, Jin J, Xi B, Chen D, Lai D, Graham RM, Zhou M. Neuregulin-1/erbB-activation improves cardiac function and survival in models of ischemic, dilated, and viral cardiomyopathy. J Am Coll Cardiol. 2006 Oct 3;48(7):1438-47. doi: 10.1016/j.jacc.2006.05.057. Epub 2006 Sep 14.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZS-01-210
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