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A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure (BLAST-AHF)

23. juli 2018 opdateret af: Trevena Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure

To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

620

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina
        • Research Site
      • Ciudad De Cordoba, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Coronel Suarez, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • La Plata, Argentina
        • Research Site
      • Moron, Argentina
        • Research Site
      • Quilmes, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • San Martin, Argentina
        • Research Site
      • San Miguel de Tucumán, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Bulgarien
      • Dimitrovgrad, Bulgarien
        • Research Site
      • Kazanlak, Bulgarien
        • Research Site
      • Pazardzhik, Bulgarien
        • Research Site
      • Pleven, Bulgarien
        • Research Site
      • Smolyan, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Sites
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • Research Site
      • Saint Petersburg, Den Russiske Føderation
        • Research Site
      • Saratov, Den Russiske Føderation
        • Research Site
  • Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Wayne State University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
    • Tennessee
      • Tullahoma, Tennessee, Forenede Stater, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Michael E DeBakey VA Medical Center
  • Israel
      • Afula, Israel
        • Research Site
      • Ashkelon, Israel
        • Research Site
      • Hadera, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Nahariya, Israel
        • Research Site
      • Nazareth, Israel
        • Research Site
      • Safed, Israel
        • Research Site
  • Polen
      • Bad Nauheim, Polen
        • Research Site
      • Bialystok, Polen
        • Research Site
      • Grodzisk Mazowiecki, Polen
        • Research Site
      • Klodzko, Polen
        • Research Site
      • Kraków, Polen
        • Research Site
      • Lublin, Polen
        • Research Site
      • Ruda Slaska, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
  • Rumænien
      • Baia Mare, Rumænien
        • Research Site
      • Bucharest, Rumænien
        • Research Site
      • Cluj-Napoca, Rumænien
        • Research Site
      • Craiova, Rumænien
        • Research Site
      • Targu Mures, Rumænien
        • Research Site
  • Slovakiet
      • Bratislava, Slovakiet
        • Research Site
      • Kocise, Slovakiet
        • Research Site
      • Martin, Slovakiet
        • Research Site
  • Tjekkiet
      • Brno, Tjekkiet
        • Research Site
      • Hradec Kralove, Tjekkiet
        • Research Site
      • Olomouc, Tjekkiet
        • Research Site
      • Prague, Tjekkiet
        • Research Site
      • Praha, Tjekkiet
        • Research Site
  • Tyskland
      • Berlin, Tyskland
        • Research Site
      • Dortmund, Tyskland
        • Research Site
      • Greifswald, Tyskland
        • Research Site
  • Ungarn
      • Budapest, Ungarn
        • Research Site
      • Kaposvar, Ungarn
        • Research Site
      • Pecs, Ungarn
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Men or women aged ≥21 years and ≤ 85 years 1a.Women of non-child-bearing potential
  2. Able to provide written informed consent
  3. Pre-existing diagnosis of heart failure and at least 30 days treatment with daily oral loop diuretics
  4. Systolic blood pressure ≥105 mmHg and ≤ 160 mmHg within 30 minutes of randomization
  5. Ventricular rate ≤125 bpm. Patients with rate-controlled persistent or permanent atrial fibrillation (aFib) at screening are permitted.

  6. Presence of ADHF defined by:

    • BNP > 400 pg/mL or NT-proBNP > 1600 pg/mL

      • For patients with BMI >30 kg/m2: BNP > 200 pg/mL or NT-proBNP > 800 pg/mL
      • For patients with rate-controlled persistent or permanent aFib: BNP > 600 pg/mL or NT-proBNP > 2400 pg/mL
      • Congestion on chest radiograph (CXR)

    AND at least two (2) of the following:

    • Rales by chest auscultation
    • Edema ≥ +1 on a 0-3 + scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region.
    • Elevated jugular venous pressure (≥8 cm H2O)
  7. Receipt of a IV loop diuretic at a minimum dose 40 mg furosemide (or equivalent loop diuretic) for the treatment of dyspnea due to ADHF at least 1 hour prior to anticipated randomization and the initiation of study medication
  8. Patient report of dyspnea at rest or upon minimal exertion during screening at least one hour after administration of IV loop diuretic

Exclusion Criteria:

  1. Women who are pregnant or breast-feeding

  2. Clinical presentation:

    1. Suspected ACS based on clinical judgment
    2. Coronary revascularization in the 3 months prior to screening or planned during current admission.
    3. Temperature >38.5oC
    4. Clinically significant anemia
    5. Serum sodium >145 mEq/L (145 mmol/L)
    6. Current or planned ultrafiltration, paracentesis, hemofiltration or dialysis at time of screening
    7. Any mechanical ventilation
    8. CPAP/BiPAP discontinued less than 1 hour prior to randomization
    9. History of LVAD or IABP within the last year
    10. Intravenous radiographic contrast agent within 72 hours prior to screening or presence of acute contrast induced nephropathy at the time of screening
    11. Presence of clinically significant arrhythmia
    12. Uncertainty of ability to complete follow up

  3. Medications:

    1. nitroprusside or nesiritide
    2. Intravenous nitrates
    3. use of inotropes
    4. Use of ARBs within 7 days of prior to randomization
    5. Use of any investigational medication within 30 days
    6. clinically significant hypersensitivity or allergy to, or intolerance of, angiotensin receptor blockers

  4. Medical history:

    1. Major surgery within 8 weeks prior to screening
    2. Stroke within 3 months prior to screening
    3. eGFR (sMDRD) <20 mL/min/1.73m2 or >75 mL/min/1.73m2 between presentation and randomization
    4. Post cardiac or renal transplant
    5. Listed for renal transplant or cardiac transplant with anticipated transplant time to transplant < 6 months
    6. History of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve stenosis or severe aortic regurgitation
    7. Cardiac valvular abnormality that requires surgical correction
    8. Complex congenital heart disease
    9. Hypertrophic or restrictive cardiomyopathy
    10. significant pulmonary or hepatic disease that could interfere with the evaluation of safety or efficacy of TRV027
    11. life expectancy of less than 6 months

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TRV027 dose #1
TRV027 dose #1 via continuous IV infusion
Medicin: TRV027 Dose #1
TRV027 continuous intravenous infusion Dose #1
Andre navne:
  • Formerly known as TRV120027
Eksperimentel: TRV027 dose #2
TRV027 dose #2 via continuous IV infusion
Medicin: TRV027 Dose #2
TRV027 continuous intravenous infusion Dose #2
Andre navne:
  • Formerly known as TRV120027
Eksperimentel: TRV027 dose #3
TRV027 dose #3 via continuous IV infusion
Medicin: TRV027 Dose #3
TRV027 continuous intravenous infusion Dose #3
Andre navne:
  • Formerly known as TRV120027
Placebo komparator: Placebo
Placebo via continuous IV infusion
Medicin: Placebo
Placebo continuous intravenous infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
composite z score
Tidsramme: 30 days
The primary clinical endpoint is a of the following outcomes: (1) time from randomization to death through day 30, (2) time from randomization to heart failure re-hospitalization through day 30, (3) time from randomization to worsening heart failure through day 5, (4) change in dyspnea VAS score (calculated area under the curve) from baseline through day 5, and (5) length of initial hospital stay (in days) from randomization. The component outcomes will be combined by deriving an average Z for each patient.
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Trevena Inc.

Efterforskere

  • Studieleder: David Soergel, MD, Trevena Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2013

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

2. september 2013

Først indsendt, der opfyldte QC-kriterier

16. oktober 2013

Først opslået (Skøn)

21. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CP027.2002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med TRV027 Dose #1

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Montenegro

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner