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

• ClinicalTrials.gov Identifier: NCT01187836
• Recruitment Status: Completed
• First Posted: August 24, 2010
• Last Update Posted: July 11, 2017
• Sponsor: Trevena Inc.
• Information provided by (Responsible Party): Trevena Inc.

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Drug: TRV120027; Drug: Placebo	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: December 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: TRV120027	Drug: TRV120027; Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.
Placebo Comparator: Placebo	Drug: Placebo; Placebo administered for 14 hours.

Outcome Measures

Primary Outcome Measures :

1. Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: 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.
2. Safety and Tolerability [ 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) ]
   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 :

1. Pharmacokinetics of TRV120027 [ Time Frame: 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.
2. Additional Hemodynamics [ Time Frame: 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.
3. Laboratory Evaluations [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

Miami, Florida, United States, 33136

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132

Czechia

CZ05

Brno, Czechia, 656 91

CZ04

Olomouc, Czechia, 779 00

CZ06

Prague, Czechia, 150 30

Poland

PL01

Warsaw, Poland, 04-628

PL05

Wroclaw, Poland, 50-981

Sponsors and Collaborators

Trevena Inc.

Investigators

• Study Director: David G Soergel, M.D.; Trevena Inc.

More Information

• Responsible Party: Trevena Inc.
• ClinicalTrials.gov Identifier: NCT01187836
• Other Study ID Numbers: CP120027.2001; 2010-020376-37 ( EudraCT Number )
• First Posted: August 24, 2010
• Last Update Posted: July 11, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases