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

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ClinicalTrials.gov Identifier: NCT01966601
Recruitment Status : Unknown
Verified September 2015 by Trevena Inc..
Recruitment status was:  Recruiting
First Posted : October 21, 2013
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Drug: TRV027 Dose #1 Drug: TRV027 Dose #2 Drug: TRV027 Dose #3 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
Study Start Date : December 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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 Name: Formerly known as TRV120027
Placebo Comparator: Placebo
Placebo via continuous IV infusion
Drug: Placebo
Placebo continuous intravenous infusion


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966601


Contacts
Contact: Clinical Operations clinicaltrials@trevenainc.com

  Show 67 Study Locations
Sponsors and Collaborators
Trevena Inc.
Investigators
Study Director: David Soergel, MD Trevena Inc.
More Information

Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT01966601     History of Changes
Other Study ID Numbers: CP027.2002
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases