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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020376-37 | EudraCT Number |
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In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of TRV120027. The results of this study will help choose the proper range of TRV120027 doses to use in future research studies involving patients with acute decompensated heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV120027 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV120027 | Drug | Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Capillary Wedge Pressure (PCWP) | The effect of TRV120027 on pulmonary capillary wedge pressure will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion |
| Safety and Tolerability | Safety and tolerability will be assessed qualitatively by evaluating adverse events, clinical laboratories, ECGs, cardiac telemetry and vital signs at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. Follow-up assessments for adverse events at Day 7 and Day 30 will be conducted. | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of TRV120027 | PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods. | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion |
| Additional Hemodynamics |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Soergel, M.D. | Trevena Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33136 | United States | |||
| University of Maryland |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C555534 | Sar-Arg-Val-Tyr-Ile-His-Pro-Ala-OH |
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| Placebo | Drug | Placebo administered for 14 hours. |
|
Additional hemodynamic variables (for example, right atrial pressure, pulmonary arterial pressure and cardiac output) will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. |
| Multiple time points during 14 hr infusion and during 4 hr period after end of infusion |
| Laboratory Evaluations | Biomarkers of renal function and neurohormonal activation will be assessed at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion, and again at follow-up Day 7. | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7) |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| CZ05 | Brno | 656 91 | Czechia |
| CZ04 | Olomouc | 779 00 | Czechia |
| CZ06 | Prague | 150 30 | Czechia |
| PL01 | Warsaw | 04-628 | Poland |
| PL05 | Wroclaw | 50-981 | Poland |