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Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF (RELAX-AHF-ASIA)

12 giugno 2019 aggiornato da: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo Controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

876

Fase

  • Fase 3

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

  • Cina
      • Beijing, Cina, 100050
        • Novartis Investigative Site
      • Chongqing, Cina, 400037
        • Novartis Investigative Site
      • Shanghai City, Cina
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, Cina, 100039
        • Novartis Investigative Site
      • Beijing, Beijing, Cina, 100037
        • Novartis Investigative Site
    • Gansu
      • Lanzhou, Gansu, Cina, 730030
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Cina, 51000
        • Novartis Investigative Site
      • Guangzhou, Guangdong, Cina, 510515
        • Novartis Investigative Site
    • Jiangsu
      • Suzhou, Jiangsu, Cina, 215006
        • Novartis Investigative Site
      • Yangzhou, Jiangsu, Cina
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, Cina, 110000
        • Novartis Investigative Site
      • Shenyang, Liaoning, Cina, 110003
        • Novartis Investigative Site
    • Shanghai
      • Jinshan, Shanghai, Cina, 201508
        • Novartis Investigative Site
      • Shanghai, Shanghai, Cina, 200032
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, Cina, 710061
        • Novartis Investigative Site
    • Tianjin
      • Tianjin, Tianjin, Cina, 300121
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310013
        • Novartis Investigative Site
      • Wenzhou, Zhejiang, Cina, 325000
        • Novartis Investigative Site
  • Corea, Repubblica di
      • Busan, Corea, Repubblica di, 602739
        • Novartis Investigative Site
      • Gwangju, Corea, Repubblica di, 61469
        • Novartis Investigative Site
      • Incheon, Corea, Repubblica di, 405 760
        • Novartis Investigative Site
      • Seoul, Corea, Repubblica di, 03080
        • Novartis Investigative Site
      • Seoul, Corea, Repubblica di, 03722
        • Novartis Investigative Site
      • Seoul, Corea, Repubblica di, 02841
        • Novartis Investigative Site
    • Bucheon Si
      • Gyeonggi do, Bucheon Si, Corea, Repubblica di, 422-711
        • Novartis Investigative Site
    • Chungcheongbuk Do
      • Cheongju si, Chungcheongbuk Do, Corea, Repubblica di, 28644
        • Novartis Investigative Site
    • Gangwon-do
      • Wonju, Gangwon-do, Corea, Repubblica di, 26427
        • Novartis Investigative Site
    • Gyeonggi Do
      • Bundang Gu, Gyeonggi Do, Corea, Repubblica di, 13620
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Corea, Repubblica di, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Corea, Repubblica di, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Corea, Repubblica di, 08308
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Corea, Repubblica di, 06591
        • Novartis Investigative Site
  • Filippine
      • Makati City, Filippine, 1229
        • Novartis Investigative Site
      • Manila, Filippine, 1003
        • Novartis Investigative Site
      • Pasig City, Filippine, 1605
        • Novartis Investigative Site
      • Quezon City, Filippine, 1102
        • Novartis Investigative Site
      • Quezon City, Filippine, 1113
        • Novartis Investigative Site
      • San Juan City, Filippine, 1500
        • Novartis Investigative Site
    • Manila
      • Quezon City, Manila, Filippine, 1100
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Filippine, 1000
        • Novartis Investigative Site
  • Giappone
      • Osaka, Giappone, 534-0021
        • Novartis Investigative Site
      • Saitama, Giappone, 330 8503
        • Novartis Investigative Site
    • Aichi
      • Nagakute-city, Aichi, Giappone, 480-1195
        • Novartis Investigative Site
      • Seto-city, Aichi, Giappone, 489-8642
        • Novartis Investigative Site
    • Chiba
      • Kamogawa-city, Chiba, Giappone, 2968602
        • Novartis Investigative Site
    • Ehime
      • Saijo-city, Ehime, Giappone, 793-0027
        • Novartis Investigative Site
    • Fukuka
      • Chikushino-city, Fukuka, Giappone, 818-8516
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Giappone, 810-0001
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Giappone, 811-0213
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Giappone, 815-8588
        • Novartis Investigative Site
      • Iizuka-city, Fukuoka, Giappone, 820-8505
        • Novartis Investigative Site
      • Kurume-city, Fukuoka, Giappone, 830-8543
        • Novartis Investigative Site
      • Kurume-city, Fukuoka, Giappone, 830-8577
        • Novartis Investigative Site
    • Gifu
      • Ogaki-city, Gifu, Giappone, 503-8502
        • Novartis Investigative Site
    • Hokkaido
      • Kushiro-city, Hokkaido, Giappone, 085-0062
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Giappone, 006-8555
        • Novartis Investigative Site
    • Hyogo
      • Amagasaki city, Hyogo, Giappone, 660 8550
        • Novartis Investigative Site
      • Kobe-City, Hyogo, Giappone, 654-0155
        • Novartis Investigative Site
    • Ibaraki
      • Mito-city, Ibaraki, Giappone, 311-4198
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Giappone, 920 8650
        • Novartis Investigative Site
    • Kagawa
      • Kanonji-city, Kagawa, Giappone, 769-1695
        • Novartis Investigative Site
      • Takamatsu city, Kagawa, Giappone, 760 8557
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki-city, Kanagawa, Giappone, 211-8533
        • Novartis Investigative Site
      • Yokohama city, Kanagawa, Giappone, 232 0024
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Giappone, 236 0051
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Giappone, 227-8501
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Giappone, 231-8682
        • Novartis Investigative Site
    • Kochi
      • Kochi city, Kochi, Giappone, 781 8555
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto-city, Kumamoto, Giappone, 861-4193
        • Novartis Investigative Site
      • Yatsushiro-city, Kumamoto, Giappone, 866-8660
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Giappone, 607-8062
        • Novartis Investigative Site
      • Uji-city, Kyoto, Giappone, 611-0042
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Giappone, 981-3133
        • Novartis Investigative Site
    • Nagano
      • Nakano-city, Nagano, Giappone, 383-8505
        • Novartis Investigative Site
      • Saku-city, Nagano, Giappone, 3850051
        • Novartis Investigative Site
      • Ueda-city, Nagano, Giappone, 386-8610
        • Novartis Investigative Site
    • Niigata
      • Niigata-city, Niigata, Giappone, 950-1197
        • Novartis Investigative Site
    • Osaka
      • Osaka-city, Osaka, Giappone, 540-0006
        • Novartis Investigative Site
    • Saitama
      • Kawaguchi-city, Saitama, Giappone, 333-0842
        • Novartis Investigative Site
      • Sayama-city, Saitama, Giappone, 350-1323
        • Novartis Investigative Site
      • Wako-city, Saitama, Giappone, 351-0102
        • Novartis Investigative Site
    • Shiga
      • Kusatsu city, Shiga, Giappone, 525 8585
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu-city, Shizuoka, Giappone, 430-8558
        • Novartis Investigative Site
      • Kakegawa-city, Shizuoka, Giappone, 436-8555
        • Novartis Investigative Site
    • Tokyo
      • Akishima-city, Tokyo, Giappone, 196-0003
        • Novartis Investigative Site
      • Chuo ku, Tokyo, Giappone, 104-8560
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Giappone, 192-0918
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, Giappone, 173-8610
        • Novartis Investigative Site
      • Musashino-city, Tokyo, Giappone, 180-8610
        • Novartis Investigative Site
      • Shinagawa ku, Tokyo, Giappone, 141 8625
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Giappone, 142-8666
        • Novartis Investigative Site
    • Wakayama
      • Tanabe-city, Wakayama, Giappone, 646-8558
        • Novartis Investigative Site
  • Giordania
      • Amman, Giordania, 11183
        • Novartis Investigative Site
      • Amman, Giordania, 11184
        • Novartis Investigative Site
    • JOR
      • Amman, JOR, Giordania, 11152
        • Novartis Investigative Site
  • India
      • Rajasthan, India, 334003
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380054
        • Novartis Investigative Site
      • Vadodara, Gujarat, India, 390022
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Novartis Investigative Site
      • Nagpur, Maharashtra, India, 440012
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600101
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Novartis Investigative Site
  • Libano
      • Ashrafieh, Libano, 166830
        • Novartis Investigative Site
      • Beirut, Libano, 1107 2020
        • Novartis Investigative Site
      • Beirut, Libano
        • Novartis Investigative Site
      • Hazmieh, Libano, 470
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
      • Kuala Lumpur, Malaysia, 50400
        • Novartis Investigative Site
    • MYS
      • Kuala Lumpur, MYS, Malaysia, 56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88300
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 94300
        • Novartis Investigative Site
    • Selangor Darul Ehsan
      • Kuala Lumpur, Selangor Darul Ehsan, Malaysia, 43000
        • Novartis Investigative Site
      • Sungai Buloh, Selangor Darul Ehsan, Malaysia, 47000
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169609
        • Novartis Investigative Site
      • Singapore, Singapore, 117549
        • Novartis Investigative Site
  • Tailandia
      • Bangkok, Tailandia, 10330
        • Novartis Investigative Site
      • Bangkok, Tailandia, 10700
        • Novartis Investigative Site
      • Bangkok, Tailandia, 10400
        • Novartis Investigative Site
      • Chiang Mai, Tailandia, 50200
        • Novartis Investigative Site
      • Muang, Tailandia, 40002
        • Novartis Investigative Site
    • Hat Yai
      • Songkhla, Hat Yai, Tailandia, 90110
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 80756
        • Novartis Investigative Site
      • Kaohsiung City, Taiwan, 83301
        • Novartis Investigative Site
      • New Taipei, Taiwan, 22060
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 10449
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
      • Yilan, Taiwan, 26058
        • Novartis Investigative Site

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:

  • Male or female ≥ 18 years of age, with body weight ≤160 kg

  • Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening:

    • Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization
    • Pulmonary congestion on chest radiograph
    • Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL
  • Systolic BP ≥125 mmHg at the start and at the end of screening
  • Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
  • Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
  • Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).

Exclusion Criteria:

  • Dyspnea primarily due to non-cardiac causes
  • Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).

  • Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment

    *Patients with systolic blood pressure >180 mmHg at the end of screening

  • AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute

  • Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).

    *Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis

  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.
Droga: Placebo
Infusione endovenosa
Altro: Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Sperimentale: Serelaxin
Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.
Altro: Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Droga: Serelaxina
Infusione endovenosa

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
Lasso di tempo: through day 5
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
through day 5

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to WHF
Lasso di tempo: Through Day 5
Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).
Through Day 5
Time to CV Death
Lasso di tempo: Through Day 180
analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).
Through Day 180
Time to All-cause Death
Lasso di tempo: Through Day 180
Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).
Through Day 180
Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days
Lasso di tempo: Through Day 5
Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale
Through Day 5
Dyspnea by VAS-AUC Changes
Lasso di tempo: Through Day 5
Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours
Through Day 5
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Lasso di tempo: Up to day 30
Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day
Up to day 30
Renal Dysfunction and Prevention of Worsening of Renal Function
Lasso di tempo: Through Day 5
number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5
Through Day 5
Time to Re-hospitalization Due to Heart Failure and Renal Impairment
Lasso di tempo: Through Day 180
Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment
Through Day 180
Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure
Lasso di tempo: Through Day 180
Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).
Through Day 180
Time to In-hospital Worsening Heart Failure Through Day 5
Lasso di tempo: Through Day 5
Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.
Through Day 5
Use of Loop Diuretic and Vasoactive Agents
Lasso di tempo: Through Day 5
Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5
Through Day 5
Change From Baseline in Cardio-renal Biomarkers
Lasso di tempo: Day 2 and Day 5
Day 2 and Day 5
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
Lasso di tempo: For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.
To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.
For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.

Collaboratori e investigatori

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

Sponsor

Novartis Pharmaceuticals

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 (Effettivo)

12 marzo 2014

Completamento primario (Effettivo)

27 marzo 2017

Completamento dello studio (Effettivo)

16 giugno 2017

Date di iscrizione allo studio

Primo inviato

20 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

9 dicembre 2013

Primo Inserito (Stima)

11 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CRLX030A2302

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

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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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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