Single-center, randomized, open, controlled by echocardiography to evaluate the effect of serelaxina in the functioning of the right ventricle and its potential in the prognosis of acute heart failure impact.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2015
INTERVENTION: Product Name: Serelaxina Pharmaceutical Form: Solution for infusion INN or Proposed INN: SERELAXIN Current Sponsor code: RLX030 Concentration unit: µg/kg microgram(s)/kilogram Concentration type: equal Concentration number: 30‐ CONDITION: ICA hospitalized patients with high normal blood pressure, and mild to moderate renal failure at the time of selection ; MedDRA version: 18.0 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Clarify the pathophysiological mechanism that could contribute to a better outcome in patients treated with serelaxina, determining changes in the function of the right ventricle (RV) by echocardiography compared with patients receiving standard therapy only. Primary end point(s): The main variable is the difference between TAPSE values (mm) at baseline and 8‐12 hours post treatment and the difference between baseline values TAPSE After a week follow‐up Secondary Objective: Assessing changes in systolic pulmonary artery pressure (PSAP) after treatment with serelaxina compared to patients receiving only the reference therapy.; Evaluating changes in the size and volume of the right ventricle and atrium serelaxina after treatment compared with patients receiving only reference therapy.; Evaluate changes in systolic and diastolic left ventricular (LV) after treatment with serelaxina compared to patients receiving only standard therapy.; Assessing changes in BNP levels and troponin I after treatment with serelaxina compared to patients receiving only the reference therapy.; To evaluate the incidence of adverse events (AEs) and serious adverse events (AAGS) in the two study groups Timepoint(s) of evaluation of this end point: 17 months SECONDARY OUTCOME: Secondary end point(s): Changes in systolic pulmonary artery pressure (PASP); Changes in the size and volume of the RV and right atrium (RA); Changes in systolic and diastolic LV function; Changes in levels of BNP and troponin.; Hospital readmissions and deaths Timepoint(s) of evaluation of this end point: 17 months INCLUSION CRITERIA: 1. Patients who have signed the informed consent to participate in the study. 2. Systolic blood pressure> 125 mmHg and impaired renal function, defined as an estimated glomerular filtration rate (eGFR) between the presentation in the hospital and randomization of > or = 30 and < or = 75 ml / min / 1.73m2, calculated using the equation simplified Modification of Diet in Renal disease (sMDRD) 3. Patients admitted for AHF. 4. can start serelaxina infusion within 16 hours of presentation to hospital. 5. Have received intravenous furosemide at least 40 mg (or equivalent) at any time between admission to the emergency department and the beginning of the selection for the study. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Epistemonikos ID: c2de62d861a6526dad4b7957fb5671bdb60b8623
First added on: Aug 23, 2024