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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV027 dose #1 | Experimental | TRV027 dose #1 via continuous IV infusion |
|
| TRV027 dose #2 | Experimental | TRV027 dose #2 via continuous IV infusion |
|
| TRV027 dose #3 | Experimental | TRV027 dose #3 via continuous IV infusion |
|
| Placebo | Placebo Comparator | Placebo via continuous IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV027 Dose #1 | Drug | TRV027 continuous intravenous infusion Dose #1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite z score | 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 |
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Inclusion Criteria:
Men or women aged ≥21 years and ≤ 85 years 1a.Women of non-child-bearing potential
Able to provide written informed consent
Pre-existing diagnosis of heart failure and at least 30 days treatment with daily oral loop diuretics
Systolic blood pressure ≥105 mmHg and ≤ 160 mmHg within 30 minutes of randomization
Ventricular rate ≤125 bpm. Patients with rate-controlled persistent or permanent atrial fibrillation (aFib) at screening are permitted.
Presence of ADHF defined by:
BNP > 400 pg/mL or NT-proBNP > 1600 pg/mL
AND at least two (2) of the following:
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
Patient report of dyspnea at rest or upon minimal exertion during screening at least one hour after administration of IV loop diuretic
Exclusion Criteria:
Women who are pregnant or breast-feeding
Clinical presentation:
Medications:
Medical history:
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| Name | Affiliation | Role |
|---|---|---|
| David Soergel, MD | Trevena Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48202 | United States | ||
| University of Cincinnati |
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| TRV027 Dose #2 | Drug | TRV027 continuous intravenous infusion Dose #2 |
|
|
| TRV027 Dose #3 | Drug | TRV027 continuous intravenous infusion Dose #3 |
|
|
| Placebo | Drug | Placebo continuous intravenous infusion |
|
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Tennessee Center for Clinical Trials | Tullahoma | Tennessee | 37388 | United States |
| Michael E Debakey VA Medical Center | Houston | Texas | 77030 | 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 Martin | 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 |
| ID | Term |
|---|---|
| C555534 | Sar-Arg-Val-Tyr-Ile-His-Pro-Ala-OH |
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