Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGTRV120027
Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.
DRUGPlacebo
Placebo administered for 14 hours.
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of congestive heart failure made at least 3 months prior to screening * NYHA Class III or IV heart failure, ejection fraction \</= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated. * Baseline mean PCWP \>/= 20 mmHg * Systolic blood pressure at screening must be \>/= 100 mmHg. Heart rate at screening must be \</= 90 bpm.
Exclusion criteria
* Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests. * Significant valve disease * Current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (ACS) or coronary revascularization in the past 3 months. * Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Capillary Wedge Pressure (PCWP) | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion | 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. |
| Safety and Tolerability | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of TRV120027 | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion | PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods. |
| Additional Hemodynamics | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion | 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. |
| Laboratory Evaluations | Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7) | 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. |
Countries
Czechia, Poland, United States
Outcome results
None listed