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

July 23, 2018 updated by: 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

620

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • Bulgaria
      • Dimitrovgrad, Bulgaria
        • Research Site
      • Kazanlak, Bulgaria
        • Research Site
      • Pazardzhik, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Smolyan, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Sites
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
  • Czechia
      • Brno, Czechia
        • Research Site
      • Hradec Kralove, Czechia
        • Research Site
      • Olomouc, Czechia
        • Research Site
      • Prague, Czechia
        • Research Site
      • Praha, Czechia
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Greifswald, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Kaposvar, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
  • 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
  • Poland
      • Bad Nauheim, Poland
        • Research Site
      • Bialystok, Poland
        • Research Site
      • Grodzisk Mazowiecki, Poland
        • Research Site
      • Klodzko, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Romania
      • Baia Mare, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Cluj-Napoca, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Targu Mures, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Saratov, Russian Federation
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kocise, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRV027 dose #1
TRV027 dose #1 via continuous IV infusion
Drug: TRV027 Dose #1
TRV027 continuous intravenous infusion Dose #1
Other Names:
  • Formerly known as TRV120027
Experimental: TRV027 dose #2
TRV027 dose #2 via continuous IV infusion
Drug: TRV027 Dose #2
TRV027 continuous intravenous infusion Dose #2
Other Names:
  • Formerly known as TRV120027
Experimental: TRV027 dose #3
TRV027 dose #3 via continuous IV infusion
Drug: TRV027 Dose #3
TRV027 continuous intravenous infusion Dose #3
Other Names:
  • Formerly known as TRV120027
Placebo Comparator: Placebo
Placebo via continuous IV infusion
Drug: Placebo
Placebo continuous intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite z score
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trevena Inc.

Investigators

  • Study Director: David Soergel, MD, Trevena Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP027.2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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