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Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TRV120027
Placebo
Sponsored by
Trevena Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Maryland
  • Tufts Medical Center
  • University of Utah
  • CZ05
  • CZ04
  • CZ06
  • PL01
  • PL05

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRV120027

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Pharmacokinetics of TRV120027
PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods.
Additional Hemodynamics
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
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.

Full Information

First Posted
August 20, 2010
Last Updated
July 7, 2017
Sponsor
Trevena Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01187836
Brief Title
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Adaptive, Ascending Dose-Titration Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Invasive Hemodynamics of TRV120027 in Patients With Stable Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevena Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRV120027
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TRV120027
Intervention Description
Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered for 14 hours.
Primary Outcome Measure Information:
Title
Pulmonary Capillary Wedge Pressure (PCWP)
Description
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.
Time Frame
Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
Title
Safety and Tolerability
Description
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.
Time Frame
Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30)
Secondary Outcome Measure Information:
Title
Pharmacokinetics of TRV120027
Description
PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods.
Time Frame
Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
Title
Additional Hemodynamics
Description
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.
Time Frame
Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
Title
Laboratory Evaluations
Description
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.
Time Frame
Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Soergel, M.D.
Organizational Affiliation
Trevena Inc.
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
CZ05
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
CZ04
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
CZ06
City
Prague
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
PL01
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
PL05
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland

12. IPD Sharing Statement

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Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure

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