Tezosentan in Acute Heart Failure

Completed · Phase 3

Conditions studied: Acute Heart Failure, Acute Decompensation of Chronic Heart Failure, New Onset of Heart Failure

In brief

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.

Key facts

Study ID: NCT00525707
Run by: Idorsia Pharmaceuticals Ltd.
People needed: 735
Starts: 2003-04-01
Expected to finish: 2005-01-01
Last updated by the study team: 2018-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients 18 years of age or older.
Male or non-breast-feeding, non-pregnant female (only females who are post menopausal, surgically sterile or practicing a reliable method of contraception).
Acute heart failure (ischemic or non-ischemic).
Randomization within 24 hours of hospitalization (including emergency room stay) for acute heart failure.
Dyspnea at rest as assessed by the patient and breathing rate ³ 24/min (measured during 60 seconds).
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).
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).
Written informed consent.

You may not qualify if…

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.
Heart failure due to active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy or constrictive pericarditis. Heart failure caused by valvular disease.
Acute heart failure associated with uncontrolled hemodynamically relevant atrial fibrillation/flutter or ventricular rhythm disturbances.
Acute heart failure secondary to clinical evidence of digoxin toxicity or any other drug-related toxicity.
Significant chronic and/or acute lung disease that might interfere with the ability to interpret the dyspnea assessments or hemodynamic measurements (e.g., severe chronic obstructive pulmonary disease or acute pneumonia).
Mechanical circulatory or ventilatory support. Prior CPAP use is allowed, if discontinued at least 2 hours prior to study drug initiation.
Acute systemic infection/sepsis or other illness with a life expectancy less than 30 days.
Coronary artery bypass graft, or other cardiac surgery, or major non-cardiac surgery within the last 30 days.
Patients who received another investigational drug within 30 days prior to randomization.
Re-randomization in the current study.
Any factors that might interfere with the study conduct or interpretation of the results such as known drug or alcohol dependence.
Concomitant treatment with cyclosporin A or tacrolimus.

Where it is running

University of Alabama-Birmingham — Birmingham, Alabama, United States
Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section — Palo Alto, California, United States
Denver VAMC — Denver, Colorado, United States
The Heart Hospital at Alledgheny General, Division of Cardiology — Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center — Houston, Texas, United States
Tyler Cardiovascular Consultants — Tyler, Texas, United States
Danville Medical Center — Danville, Virginia, United States
Medical Associates, Bellebue — Bellevue, Washington, United States
AKH University of Vienna, Abt. Medizinische Kardiologie — Vienna, Austria
Roskilde Amt Sygehus — Roskilde, Denmark
Hopital Ambroise Pare, Service de Cardiologie — Boulogne, France
Heart Failure clinic C.H. Dubos — Pontoise, France
Hopitaux Universitaires de Strasbourg, Hopital Hautepierre — Strasbourg, France
CHU Rangueil, Cardiologie A — Toulouse, France
Medizinische Klinik I, Universitatsklinikum Aachen — Aachen, Germany
Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie — Berlin, Germany
Georg-August-Universitat Gottingen, Zentrum fur Innere Med — Göttingen, Germany
Dept. of Cardiology, University of Athens, Alexandra Hospital — Athens, Greece
Barzilai Hospital — Ashkelon, Israel
Carmel Medical Center — Haifa, Israel
Wolfson Medical Center — Holon, Israel
Hadassah Hospital — Jerusalem, Israel
Nazareth Hospital EMMS — Nazareth, Israel
Assaf-Harofeh Medical Center — Ẕerifin, Israel
Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital — Bydgoszcz, Poland

Full record on ClinicalTrials.gov

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