EUCTR2007-004271-19-ES
Active, not recruiting
Phase 1
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.Estudio de fase II/III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de relaxina en sujetos con insuficiencia cardíaca aguda - RELAX-AHF
ConditionsPatients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment. Pacientes hospitalizados con insuficiencia cardíaca aguda (ICA), presión arterial normal o elevada y disfunción renal leve o moderadaMedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failure
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment. Pacientes hospitalizados con insuficiencia cardíaca aguda (ICA), presión arterial normal o elevada y disfunción renal leve o moderada
- Sponsor
- Corthera, Inc.
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Able to provide written informed consent
- •2\. Male or female ? 18 years of age, with body weight \<160 kg
- •3\. Systolic blood pressure \> 125 mmHg at the start of screening and at the end of screening
- •4\. Hospitalized for AHF. AHF is defined as including all of the following measured at any
- •time between presentation (including the emergency department \[ED]) and the end of
- •a. Dyspnea at rest or with minimal exertion
- •b. Pulmonary congestion on chest radiograph
- •c. BNP ? 350pg/mL or NT\-pro\-BNP ?1400 pg/mL
- •5\. Able to be randomized within 16 hours from presentation to the hospital, including the ED
- •6\. Received IV furosemide of at least 40 mg (or equivalent) at any time between admission
Exclusion Criteria
- •1\. Pregnant or breast\-feeding women (women of child bearing potential must have the
- •results of a negative pregnancy test recorded prior to study drug administration)
- •2\. Administration of intravenous radiographic contrast agent within 72 hours prior to
- •screening or acute contrast\-induced nephropathy at the time of screening
- •3\. Temperature \>38°C (oral or equivalent) or sepsis or active infection requiring IV anti\-
- •microbial treatment
- •4\. Current (within 2 hours prior to screening) or planned (through the completion of study
- •drug infusion) treatment with any IV therapies, including vasodilators (including
- •nesiritide), positive inotropic agents and vasopressors, or mechanical support (intra\-aortic
- •balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist
Outcomes
Primary Outcomes
Not specified
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A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-ControlledStudy to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure. - RELAX-AHFPatients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.MedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failureEUCTR2007-004271-19-FRCorthera, Inc.