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
Conditions
Interventions
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: equa
Sponsors
Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Temperature> 38.5 ° C (oral or equivalent) or sepsis or active infection that requires antibiotic treatment iv 2. Dyspnea mainly due to noncardiac causes. 3. Clinical evidence of acute currently or within 30 days prior to enrollment coronary syndrome. 4. Significant tract obstruction greets the left ventricle, such as hypertrophic obstructive cardiomyopathy or severe aortic stenosis (ie, aortic valve area 50 mmHg in previous or current echocardiogram), severe aortic regurgitation and severe mitral stenosis. 5. Current treatment (within 2 hours prior to screening) or planned (until the end of the infusion of study medication) with any iv vasoactive therapy, including vasodilators, positive inotropes and vasopressors or mechanical support, except for iv furosemide (or equivalent), or nitrates i.v. at a dose of 150 mmHg in the selection. 6. ICA due to major arrhythmias (including any of the following: sustained ventricular tachycardia, bradycardia 130 beats per minute), acute myocarditis or hypertrophic obstructive cardiomyopathy, constrictive or restrictive. 7. Patients with severely impaired renal function defined as an eGFR <25 ml / min / 1.73m2, calculated using equation sMDRD. 8. Receiver of any organ or patient with anticipated / planned for next year transplant. 9. major or important in the 30 days prior to screening neurological event Surgery. 10. Hypersensitivity to serelaxina or similar substances or any other excipient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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;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;Timepoint(s) of evaluation of this end point: 17 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactDr. Jose Luis Zamorano Gómez
Hospital Ramón y Cajal
Outcome results
None listed