Acute Heart Failure MedDRA version: 16.1 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: Serelaxin
Product Code: RLX030
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SERELAXIN
CAS Number: 99489-94-8
Other descriptive name: RLX030
Concentration unit: mg/ml m
Sponsors
Ospedale San Raffaele s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Dyspnea at rest or with minimal exertion Pulmonary congestion on chest radiograph Able to start serelaxin infusion within 16 hours from presentation to the hospital Received IV furosemide of at least 40 mg (or equivalent) at any time between admission to emergency services (either ambulance or hospital, including the ED) and the start of screening for the study. Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission between 30-75 mL/min/1•73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: Dyspnoea primarily due to non-cardiac causes Women of child bearing potential or pregnant or nursing (lactating) women Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment Current (within 2 hours prior to screening) or planned treatment with any IV vasoactive therapies, including vasodilators, positive inotropic agents and vasopressors, or mechanical support, with the exception of IV furosemide (or equivalent) or IV nitrates = 0.1mg/kg if the patient has a systolic BP >150 mmHg at screening Significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area 50 mmHg on prior or current echocardiogram) and severe mitral stenosis Known hepatic impairment, or AST or ALT >3 times Upper Limit of Normal of unknown source Known presence of active or recurrent bacterial, fungal or viral infection at the time of enrollment, e.g. evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infections (based on history and/or clinical findings, including laboratory results obtained during screening period, known significant pulmonary disease. Shock regardless of aetiology AHF caused by significant arrhythmias, acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy Clinical evidence of Acute Coronary Syndrome currently or diagnosed within 30 days prior to enrolment. (Note that the diagnosis of acute coronary syndrome is a clinical diagnosis and that the sole presence of elevated troponin concentrations is not sufficient for a diagnosis of acute coronary syndrome, given that troponin concentrations may be significantly increased in the setting of AHF) Troponin =3 times the level indicative of myocardial infarction Known hypersensitivity to Serelaxin or similar substances or to any of the excipients Pacemaker or ICD. Implanted ferromagnetic cerebrovascular clips. Claustrophobia. Involved in other research studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of a significant reduction in indexed left ventricular end systolic volume (LVESVi) assessed by cardiac magnetic resonance (CMR) in the serelaxin group compared to controls at 6 months follow up.;Secondary Objective: Changes in LVESVi, assessed by echo, between baseline and 6 month in the serelaxin group compared to controls. - Correlation between changes in echocardiographic parameters of cardiac function and cardiac, renal and hepatic biomarkers. - Changes in late gadolinium enhancement at CMR in the two groups between baseline and 6 months. - Comparison of the NYHA functional class at 6 months between the Serelaxin group and controls. ;Primary end point(s): The primary endpoint of the study is the demonstration of a significant reduction in indexed left ventricular end systolic volume (LVESVi) assessed by cardiac magnetic resonance (CMR) in the serelaxin group compared to controls at 6 months follow up.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in LVESVi, assessed by echo, between baseline and 6 month in the serelaxin group compared to controls. - Correlation between changes in echocardiographic parameters of cardiac function assessed at screening (visit 0), 24 hour, 48 hours, day 4 and at 1, 2, 6 months and cardiac, renal and hepatic biomarkers assessed at baseline, 24 hour, 48 hours, day 4 and at 6 months. - Changes in late gadolinium enhancement at CMR in the two groups between baseline and 6 months. - Comparison of the NYHA functional class at 6 month between the Serelaxin group and controls. ;Timepoint(s) of evaluation of this end point: Baseline, 24 hour, 48 hours, day 4 and at 6 months | — |
Countries
Italy
Contacts
Public ContactUfficio Ricerche Cliniche
Ospedale San Raffaele Srl
Outcome results
None listed