Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

keskiviikko 12. kesäkuuta 2019 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

876

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Filippiinit
      • Makati City, Filippiinit, 1229
        • Novartis Investigative Site
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      • Pasig City, Filippiinit, 1605
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      • San Juan City, Filippiinit, 1500
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    • Manila
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    • Metro Manila
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    • Delhi
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      • Amagasaki city, Hyogo, Japani, 660 8550
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    • Ibaraki
      • Mito-city, Ibaraki, Japani, 311-4198
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      • Kanazawa, Ishikawa, Japani, 920 8650
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    • Kagawa
      • Kanonji-city, Kagawa, Japani, 769-1695
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      • Takamatsu city, Kagawa, Japani, 760 8557
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    • Kanagawa
      • Kawasaki-city, Kanagawa, Japani, 211-8533
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      • Yokohama-city, Kanagawa, Japani, 227-8501
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    • Kochi
      • Kochi city, Kochi, Japani, 781 8555
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    • Kumamoto
      • Kumamoto-city, Kumamoto, Japani, 861-4193
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    • Kyoto
      • Kyoto-city, Kyoto, Japani, 607-8062
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      • Sendai-city, Miyagi, Japani, 981-3133
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      • Nakano-city, Nagano, Japani, 383-8505
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    • Niigata
      • Niigata-city, Niigata, Japani, 950-1197
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      • Osaka-city, Osaka, Japani, 540-0006
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      • Kawaguchi-city, Saitama, Japani, 333-0842
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    • Shiga
      • Kusatsu city, Shiga, Japani, 525 8585
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      • Hamamatsu-city, Shizuoka, Japani, 430-8558
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    • Tokyo
      • Akishima-city, Tokyo, Japani, 196-0003
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      • Hachioji-city, Tokyo, Japani, 192-0918
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      • Shinagawa ku, Tokyo, Japani, 141 8625
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    • Wakayama
      • Tanabe-city, Wakayama, Japani, 646-8558
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  • Jordania
      • Amman, Jordania, 11183
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    • JOR
      • Amman, JOR, Jordania, 11152
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  • Kiina
      • Beijing, Kiina, 100050
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      • Shanghai City, Kiina
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    • Beijing
      • Beijing, Beijing, Kiina, 100039
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    • Gansu
      • Lanzhou, Gansu, Kiina, 730030
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    • Guangdong
      • Guangzhou, Guangdong, Kiina, 51000
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      • Guangzhou, Guangdong, Kiina, 510515
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    • Jiangsu
      • Suzhou, Jiangsu, Kiina, 215006
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      • Yangzhou, Jiangsu, Kiina
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    • Liaoning
      • Shenyang, Liaoning, Kiina, 110000
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    • Shanghai
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    • Shanxi
      • Xian, Shanxi, Kiina, 710061
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      • Tianjin, Tianjin, Kiina, 300121
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    • Zhejiang
      • Hangzhou, Zhejiang, Kiina, 310013
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  • Korean tasavalta
      • Busan, Korean tasavalta, 602739
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      • Gyeonggi do, Bucheon Si, Korean tasavalta, 422-711
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      • Bundang Gu, Gyeonggi Do, Korean tasavalta, 13620
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    • Korea
      • Seoul, Korea, Korean tasavalta, 05505
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      • Seoul, Korea, Korean tasavalta, 06351
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      • Seoul, Korea, Korean tasavalta, 08308
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    • Seocho Gu
      • Seoul, Seocho Gu, Korean tasavalta, 06591
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  • Libanon
      • Ashrafieh, Libanon, 166830
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      • Beirut, Libanon, 1107 2020
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      • Beirut, Libanon
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      • Hazmieh, Libanon, 470
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  • Malesia
      • Kuala Lumpur, Malesia, 59100
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      • Kuala Lumpur, Malesia, 50400
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      • Kuala Lumpur, MYS, Malesia, 56000
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    • Sabah
      • Kota Kinabalu, Sabah, Malesia, 88300
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    • Sarawak
      • Kuching, Sarawak, Malesia, 94300
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    • Selangor Darul Ehsan
      • Kuala Lumpur, Selangor Darul Ehsan, Malesia, 43000
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      • Sungai Buloh, Selangor Darul Ehsan, Malesia, 47000
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  • Singapore
      • Singapore, Singapore, 169609
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      • Singapore, Singapore, 117549
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  • Taiwan
      • Changhua, Taiwan, 50006
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      • Kaohsiung, Taiwan, 80756
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      • Kaohsiung City, Taiwan, 83301
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      • New Taipei, Taiwan, 22060
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      • Taichung, Taiwan, 40447
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      • Taipei, Taiwan, 10002
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      • Taipei, Taiwan, 11217
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      • Taipei, Taiwan, 10449
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      • Taoyuan, Taiwan, 33305
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      • Yilan, Taiwan, 26058
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  • Thaimaa
      • Bangkok, Thaimaa, 10330
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      • Bangkok, Thaimaa, 10700
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      • Muang, Thaimaa, 40002
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    • Hat Yai
      • Songkhla, Hat Yai, Thaimaa, 90110
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Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Placebo
Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.
Lääke: Plasebo
Suonensisäinen infuusio
Muut: 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.
Kokeellinen: Serelaxin
Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.
Muut: 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.
Lääke: Serelaxin
Suonensisäinen infuusio

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time to WHF
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Day 2 and Day 5
Day 2 and Day 5
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Novartis Pharmaceuticals

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 12. maaliskuuta 2014

Ensisijainen valmistuminen (Todellinen)

Maanantai 27. maaliskuuta 2017

Opintojen valmistuminen (Todellinen)

Perjantai 16. kesäkuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 20. marraskuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 9. joulukuuta 2013

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 11. joulukuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 2. elokuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 12. kesäkuuta 2019

Viimeksi vahvistettu

Lauantai 1. kesäkuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CRLX030A2302

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

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