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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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California
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La Jolla, California, Verenigde Staten, 92037
- University of California, San Diego
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Los Angeles, California, Verenigde Staten, 90033
- Metabolic Clinic and Research Center
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Los Angeles, California, Verenigde Staten, 90033
- USC Cardiovascular Division
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Tustin, California, Verenigde Staten, 92780
- Orange County Research Center
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Colorado
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Denver, Colorado, Verenigde Staten, 80045
- University of Colorado Denver
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Florida
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Clearwater, Florida, Verenigde Staten, 33756
- Clearwater Cardiovascular & Interventional Consultants, MD, PA
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Tampa, Florida, Verenigde Staten, 33606
- University of South Florida
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
- University of Iowa Hospitals and Clinics
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Louisiana
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Kenner, Louisiana, Verenigde Staten, 70065
- MedPharmics, LLC.
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Metairie, Louisiana, Verenigde Staten, 70006
- Benchmark Research
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Texas
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Houston, Texas, Verenigde Staten, 77002
- East Texas Cardiology
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Plano, Texas, Verenigde Staten, 75075
- The Medical Center of Plano
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23507
- Sentara Cardiovascular Research Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Placebo
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Daily subcutaneous administration for 8 hours a day for 10 days
Andere namen:
|
Experimenteel: 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
Andere namen:
|
Experimenteel: 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
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from baseline in LVEF
Tijdsspanne: 30 days
|
Compared to baseline and placebo
|
30 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Six (6) minute walk test
Tijdsspanne: Day 30, 90, 180, 365
|
Compared to baseline and placebo
|
Day 30, 90, 180, 365
|
Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire)
Tijdsspanne: Day 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Day 30, 90, 180 and 365
|
NYHA class status
Tijdsspanne: Day 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Day 30, 90, 180 and 365
|
All cause mortality and all cause hospitalization
Tijdsspanne: Days 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Days 30, 90, 180 and 365
|
Change in LVESV and LVEDV
Tijdsspanne: Day 30
|
Compared to baseline and placebo
|
Day 30
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Barry Greenberg, MD, University of California, San Diego
- Hoofdonderzoeker: Uri Elkayam, MD, LAC+USC Medical Center
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ZS-01-210
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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