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Completed

NCT Number: NCT01187836

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CZ05, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRV120027

Drug

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

Placebo

Drug

Placebo administered for 14 hours.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2010
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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