NCT01187836

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 heart-failure

Timeline
Completed

Started Dec 2010

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

August 20, 2010

Last Update Submit

July 7, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (3)

  • Pharmacokinetics of TRV120027

    Multiple time points during 14 hr infusion and during 4 hr period after end of infusion

  • Additional Hemodynamics

    Multiple time points during 14 hr infusion and during 4 hr period after end of infusion

  • Laboratory Evaluations

    Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7)

Study Arms (2)

TRV120027

EXPERIMENTAL
Drug: TRV120027

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TRV120027DRUG

Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.

TRV120027
PlaceboDRUG

Placebo administered for 14 hours.

Placebo

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Miami, Florida, 33136, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

CZ05

Brno, 656 91, Czechia

Location

CZ04

Olomouc, 779 00, Czechia

Location

CZ06

Prague, 150 30, Czechia

Location

PL01

Warsaw, 04-628, Poland

Location

PL05

Wroclaw, 50-981, Poland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sar-Arg-Val-Tyr-Ile-His-Pro-Ala-OH

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • David G Soergel, M.D.

    Trevena Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 24, 2010

Study Start

December 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

US(4)CZ(3)PL(2)