A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
NCT ID: NCT01966601
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
620 participants
INTERVENTIONAL
2013-12-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
NCT01187836
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
NCT01444872
Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus
NCT04507347
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
NCT01064037
BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
NCT01065077
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TRV027 dose #1
TRV027 dose #1 via continuous IV infusion
TRV027 Dose #1
TRV027 continuous intravenous infusion Dose #1
TRV027 dose #2
TRV027 dose #2 via continuous IV infusion
TRV027 Dose #2
TRV027 continuous intravenous infusion Dose #2
TRV027 dose #3
TRV027 dose #3 via continuous IV infusion
TRV027 Dose #3
TRV027 continuous intravenous infusion Dose #3
Placebo
Placebo via continuous IV infusion
Placebo
Placebo continuous intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TRV027 Dose #1
TRV027 continuous intravenous infusion Dose #1
TRV027 Dose #2
TRV027 continuous intravenous infusion Dose #2
TRV027 Dose #3
TRV027 continuous intravenous infusion Dose #3
Placebo
Placebo continuous intravenous infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
21 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Trevena Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Soergel, MD
Role: STUDY_DIRECTOR
Trevena Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wayne State University
Detroit, Michigan, United States
University of Cincinnati
Cincinnati, Ohio, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Michael E Debakey VA Medical Center
Houston, Texas, United States
Research Site
Buenos Aires, , Argentina
Research Site
Coronel Suárez, , Argentina
Research Site
Corrientes, , Argentina
Research Site
Córdoba, , Argentina
Research Site
La Plata, , Argentina
Research Site
Morón, , Argentina
Research Site
Quilmes, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Martín, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Santa Fe, , Argentina
Research Site
Dimitrovgrad, , Bulgaria
Research Site
Kazanlak, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Pleven, , Bulgaria
Research Site
Smolyan, , Bulgaria
Research Sites
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Edmonton, Alberta, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Berlin, , Germany
Research Site
Dortmund, , Germany
Research Site
Greifswald, , Germany
Research Site
Budapest, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Pécs, , Hungary
Research Site
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
Bad Nauheim, , Poland
Research Site
Bialystok, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Krakow, , Poland
Research Site
Kłodzko, , Poland
Research Site
Lublin, , Poland
Research Site
Ruda Śląska, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Baia Mare, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Craiova, , Romania
Research Site
Târgu Mureş, , Romania
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Bratislava, , Slovakia
Research Site
Kocise, , Slovakia
Research Site
Martin, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP027.2002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.