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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01966601
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.

Tracking Information
First Submitted Date  ICMJE September 2, 2013
First Posted Date  ICMJE October 21, 2013
Last Update Posted Date July 26, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Decompensated Heart Failure
Intervention  ICMJE
  • Drug: TRV027 Dose #1
    TRV027 continuous intravenous infusion Dose #1
    Other Name: Formerly known as TRV120027
  • Drug: TRV027 Dose #2
    TRV027 continuous intravenous infusion Dose #2
    Other Name: Formerly known as TRV120027
  • Drug: TRV027 Dose #3
    TRV027 continuous intravenous infusion Dose #3
    Other Name: Formerly known as TRV120027
  • Drug: Placebo
    Placebo continuous intravenous infusion
Study Arms  ICMJE
  • Experimental: TRV027 dose #1
    TRV027 dose #1 via continuous IV infusion
    Intervention: Drug: TRV027 Dose #1
  • Experimental: TRV027 dose #2
    TRV027 dose #2 via continuous IV infusion
    Intervention: Drug: TRV027 Dose #2
  • Experimental: TRV027 dose #3
    TRV027 dose #3 via continuous IV infusion
    Intervention: Drug: TRV027 Dose #3
  • Placebo Comparator: Placebo
    Placebo via continuous IV infusion
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2015)
620
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2013)
500
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Canada,   Czechia,   Germany,   Hungary,   Israel,   Poland,   Romania,   Russian Federation,   Slovakia,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01966601
Other Study ID Numbers  ICMJE CP027.2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trevena Inc.
Study Sponsor  ICMJE Trevena Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Soergel, MD Trevena Inc.
PRS Account Trevena Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP