Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01966601 · ClinicalTrials.gov registry record · Phase 2
A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
A Phase 2 study of Acute Decompensated Heart Failure, sponsored by Trevena.
- Completed
- Registry status
- Phase 2
- Development phase
- 620
- Enrollment target
- 20
- Study locations
NCT01966601: Completed Phase 2 study of Acute Decompensated Heart Failure, sponsored by Trevena.
NCT01966601 is a Phase 2 study of Acute Decompensated Heart Failure that has completed, run by Trevena. The registered enrollment target is 620 participants, above the 407-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (52% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966601, a Phase 2 study of Acute Decompensated Heart Failure, has completed, sponsored by Trevena.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 620 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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 e
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TRV027 Dose #1
- DRUG TRV027 Dose #2
- DRUG TRV027 Dose #3
Study Locations (20)
Other
- Research Site - Buenos Aires
- Research Site - Coronel Suárez
- Research Site - Corrientes
- Research Site - Córdoba
- Research Site - La Plata
- Research Site - Morón
- Research Site - Quilmes
- Research Site - Rosario
- Research Site - San Martín
- Research Site - San Miguel de Tucumán
- Research Site - Santa Fe
- Research Site - Dimitrovgrad
- Research Site - Kazanlak
- Research Site - Pazardzhik
- Research Site - Pleven
- Research Site - Smolyan
Michigan
- Wayne State University - Detroit
Ohio
- University of Cincinnati - Cincinnati
Tennessee
- Tennessee Center for Clinical Trials - Tullahoma
Texas
- Michael E Debakey VA Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT01966601 record still lists
NCT01966601 is an interventional study that assigns participants to a tested intervention. The registered 620 participants enrollment target is mid-sized for trials with a published cap, above the 407-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (52% higher).
The record links to 1 condition, with Acute Decompensated Heart Failure appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01966601 names 20 study sites across 5 states, led by Other, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT01966601 about?
NCT01966601 is a clinical study titled "A 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).
What is the current status of trial NCT01966601?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 620 participants. The study started on 2013-12. Estimated completion is 2016-09.
What conditions does trial NCT01966601 study?
This clinical trial studies the following conditions: Acute Decompensated Heart Failure.
What interventions are being tested in trial NCT01966601?
The interventions under investigation include: Placebo (DRUG), TRV027 Dose #1 (DRUG), TRV027 Dose #2 (DRUG), TRV027 Dose #3 (DRUG).
Who is sponsoring clinical trial NCT01966601?
This trial is sponsored by Trevena, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01966601 being conducted?
This trial has 20 study locations across Michigan, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Decompensated Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01966601's enrollment target sits among peer trials
620 3rd of 12 higher than 10 of 12 other Acute Decompensated Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Decompensated Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure
RECRUITING
-
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
RECRUITING · Phase 3
-
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
RECRUITING · NA
-
Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
RECRUITING
-
IC14 for Treatment of Acute Decompensated Heart Failure
ACTIVE NOT RECRUITING · Phase 1
-
DORAYA-HF Early Feasibility Study
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02282969 · 620 participants
PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing
- NCT02838836 · 620 participants
Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
- NCT05538910 · 620 participants · NA
Defining Neurobiological Links Between Substance Use and Mental Illness
- NCT05822466 · 620 participants · NA
Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia