Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.

Idorsia Pharmaceuticals Ltd.42 sites in 8 countries713 target enrollmentApril 2003

ConditionsAcute Heart Failure Acute Decompensation of Chronic Heart Failure New Onset of Heart Failure

Interventionstezosentan placebo

Drugstezosentan placebo

Overview

Phase: Phase 3
Intervention: tezosentan
Conditions: Acute Heart Failure
Sponsor: Idorsia Pharmaceuticals Ltd.
Enrollment: 713
Locations: 42
Primary Endpoint: Incidence of death or worsening heart failure
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

January 2005

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Idorsia Pharmaceuticals Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Patients 18 years of age or older. 2.Male or non-breast-feeding, non-pregnant female (only females who are post menopausal, surgically sterile or practicing a reliable method of contraception).
•3.Acute heart failure (ischemic or non-ischemic). 4.Randomization within 24 hours of hospitalization (including emergency room stay) for acute heart failure.
•5.Dyspnea at rest as assessed by the patient and breathing rate ³ 24/min (measured during 60 seconds).
•6.At least two out of the following four criteria: · elevated BNP or N terminal pro-BNP (more than three times the upper limit of normal for the site) in patients not treated with nesiritide,· clinical evidence of pulmonary congestion/edema (e.g., rales or crackles more than a third above bases),· evidence of pulmonary congestion on chest X-ray, · left ventricular systolic dysfunction (EF \< 40% or wall motion index £ 1.2 within 12 months prior to randomization).
•7.Patients in need of i.v. therapy for acute heart failure and who have received at least one dose of i.v. diuretic within 24 hours prior to study drug initiation (last bolus dose must have been more than 2 hours prior to study drug initiation).
•8.Written informed consent.

Exclusion Criteria

•Criteria only for patients hemodynamically monitored:
•Baseline cardiac index \> 2.5 l/min/m2 and/or PCWP \< 20 mmHg within 6 hours prior to study drug initiation.
•Criteria for all patients:
•Patients not receiving i.v. vasodilators (e.g., nitrates, nitroprusside, nesiritide) at baseline: supine systolic blood pressure \< 100 mmHg. Patients receiving i.v. vasodilators (e.g., nitrates, nitroprusside, nesiritide) at baseline: supine systolic blood pressure \< 120 mmHg.
•Cardiogenic shock within the last 48 hours or evidence of volume depletion.
•Ongoing myocardial ischaemia, coronary revascularisation procedure (PCI or CABG) during current admission or planned revascularisation.
•ST-segment elevation myocardial infarction or administration of thrombolytic therapy.
•Baseline creatinine ≥ 2.5 mg/dl (221 mmol/l).
•Baseline hemoglobin \< 10 g/dl or a hematocrit \< 30%.
•Hemodialysis, ultrafiltration or peritoneal dialysis within the last 7 days.