Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
19 décembre 2017 mis à jour par: Zensun Sci. & Tech. Co., Ltd.
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
The mortality of chronic heart failure patients remains high, in spite of recent treatment.
RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it.
Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans.
In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Type d'étude
Interventionnel
Inscription (Réel)
331
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing, Chine
- Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
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Beijing, Chine
- Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
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Beijing, Chine
- Cardiovascular Institute and Fuwai Hospital
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Shanghai, Chine
- Huashan Hospital Affiliated to Fudan University
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Shanghai, Chine
- Renji Hospital, Medical School of Shanghai Jiaotong University
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Shanghai, Chine
- The first people's hospitial of Shanghai
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Shanghai, Chine
- The Sixth People's Hospital, Shanghai Jiaotong University
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Beijing
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Beijing, Beijing, Chine
- General Hospital of Chinese People's Liberation Army
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Gansu
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Lanzhou, Gansu, Chine
- The First Hospital affiliated to Lanzhou University
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Hainan
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Haikou, Hainan, Chine
- Haikou Municipal Peoples Hospital
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Hebei
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Shijiazhuang, Hebei, Chine
- Bethune International Peace Hospital
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Tianjin, Hebei, Chine
- Teda International Cardiovascular Hospital
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Heilongjiang
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Daqing, Heilongjiang, Chine
- Daqing Oilfield General Hospital
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Haerbin, Heilongjiang, Chine
- The First Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, Chine
- The First hospital affiliated to Zhengzhou University
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Hubei
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Wuchang, Hubei, Chine
- Zhongnan Hospital of Wuhan University
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Wuhan, Hubei, Chine
- Tongji Hospital affiliated to Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Chine
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, Chine
- Hunan Provincial People's Hospital
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Jiangsu
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Jiangyin, Jiangsu, Chine
- Jiangsu Jiangyin People's Hospital
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Nanjing, Jiangsu, Chine
- Nanjing Drum Tower Hospital
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Nanjing, Jiangsu, Chine
- Zhongda Hospital, Southeast University
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Suzhou, Jiangsu, Chine
- The Second Hospital Affiliated To Suzhou University
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Xuzhou, Jiangsu, Chine
- The Affiliated Hospital of Xuzhou Medical School
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Yangzhou, Jiangsu, Chine
- North Jiangsu People's Hospital
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Zhenjiang, Jiangsu, Chine
- The Affiliate Hospital of Jiangsu University
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Jilin
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Changchun, Jilin, Chine
- The Second Hospital affiliated to Jilin University
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Liaoning
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Dalian, Liaoning, Chine
- The First Hospital affiliated to Dalian Medical University
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Jinzhou, Liaoning, Chine
- The first affiliated hospital of Liaoning medical college
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Shenyang, Liaoning, Chine
- Shengjing Hospital of China Medical University
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Shenyang, Liaoning, Chine
- Liaoning Provincial People's Hospital
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Shenyang, Liaoning, Chine
- The First Hospital of China Medical Hospital
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Shandong
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Jinan, Shandong, Chine
- Qilu Hospital of Shandong University
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Jinan, Shandong, Chine
- The Second Hospital of Shandong University
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Shanxi
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Xi'an, Shanxi, Chine
- Shanxi Provincial People's Hospital
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Xi'an, Shanxi, Chine
- The second hospital of Xi'an jiaotong university
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Sichuan
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Chendu, Sichuan, Chine
- Sichuan Provincial People's Hospital
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Chendu, Sichuan, Chine
- Huaxi Hospital of Sichuan University
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Chongqin, Sichuan, Chine
- The Xinqiao Hospital of Third Military Medical University
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Yunnan
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Kunming, Yunnan, Chine
- Kunming General Hospital of Chengdu Military Region
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Kunming, Yunnan, Chine
- The Second hospital affiliated to Kunming Medical and Pharmaceutical College
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Zhejiang
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Hangzhou, Zhejiang, Chine
- Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
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Hangzhou, Zhejiang, Chine
- The First Hospital affiliated to School of Medicine, Zhejiang University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age between 18 and 80, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class III~Ⅳ.
- Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
- Capable of signing the informed consent form.
Exclusion Criteria:
- Patients with acute pulmonary edema or acute hemodynamic disorder.
- Patients with right heart failure caused by pulmonary disease.
- Patients diagnosed with pericardial effusion or pleural effusion.
- Patients with myocardial infarction during the preceding 3 months.
- Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Unstable angina pectoris.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
- Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- Systolic blood pressure <90mmHg or >160mmHg.
- Pregnant or plan to pregnant.
- Patients who participated in any clinical trial in the recent three months.
- Subject with a life expectancy less than 3 months as assessed by the investigator.
- Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
- History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
- Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
|---|---|
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Comparateur placebo: placebo
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day1~day10:0.6ug/kg/day,10hours
per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes
per time per week for vein injection
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Expérimental: rhNRG-1
recombinant human neuregulin-1
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day1~day10:0.6ug/kg/day,10hours
per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes
per time per week for vein injection
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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mortalité toutes causes
Délai: un ans
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un ans
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Runlin Gao, MD,Ph.D, Cardiovascular Institute and Fuwai Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2010
Achèvement primaire (Réel)
1 juin 2012
Achèvement de l'étude (Réel)
1 août 2012
Dates d'inscription aux études
Première soumission
25 mai 2010
Première soumission répondant aux critères de contrôle qualité
26 mai 2010
Première publication (Estimation)
27 mai 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 décembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 décembre 2017
Dernière vérification
1 juillet 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZS-01-301
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .