Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure - Full Text View

Purpose

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	Intervention	Phase
Heart Failure	Drug: TRV120027 Drug: Placebo	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Trevena Inc.:

Primary Outcome Measures:

Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion ] [ Designated as safety issue: No ]
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 [ 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) ] [ Designated as safety issue: No ]
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 [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion ] [ Designated as safety issue: No ]
PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods.
Additional Hemodynamics [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion ] [ Designated as safety issue: No ]
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 [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7) ] [ Designated as safety issue: No ]
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.

Enrollment:	33
Study Start Date:	December 2010
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187836

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
Czech Republic
CZ05
Brno, Czech Republic, 656 91
CZ04
Olomouc, Czech Republic, 779 00
CZ06
Prague, Czech Republic, 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

No publications provided

Responsible Party:	Trevena Inc.
ClinicalTrials.gov Identifier:	NCT01187836 History of Changes
Other Study ID Numbers:	CP120027.2001, 2010-020376-37
Study First Received:	August 20, 2010
Last Updated:	April 13, 2012
Health Authority:	United States: Food and Drug Administration Poland: Ministry of Health Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013