acute heart failure MedDRA version: 19.0 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: serelaxin
Product Code: RLX030
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: SERELAXIN
CAS Number: Not establis
Current Sponsor code: RLX030
Other descr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed 2. Male or female, birth to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hypovolemia 2. Moderate to severe left ventricular outflow tract (including sub-valvular, valvular and supra-valvular), mitral stenosis or aortic arch obstruction 3. Patients with single ventricle physiology before their Fontan operation (However, single ventricle patients post Glenn operation before their Fontan/Total cavopulmonary connection procedure (TCPC) can be enrolled.) 4. Patients on ECMO or VAD 5. Patients with fixed pulmonary hypertension 6. Patients with blood lactate levels >5 mmol/L at screening 7. Birth 20) 12. Current or planned use of the following concomitant medications during the duration of the study drug infusion: levosimendan, nesiritide 13. History or current diagnosis of cardiac electrocardiographic abnormalities 14. Any major solid organ transplant recipient within 1 year of transplantation 15. Any major solid organ transplant recipient who presents with severe organ rejection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - evaluate the safety and tolerability of an iv serelaxin infusion in addition to standard of care in hospitalized pediatric patients with AHF. - investigate the effects of age on the pharmacokinetics of serelaxin given as iv infusion in addition to standard of care in hospitalized pediatric patients with AHF;Secondary Objective: To evaluate the hemodynamic effects of different doses of serelaxin given as an iv infusion in addition to standard of care in hospitalized pediatric patients with AHF [efficacy parameters: arterial blood pressure, left atrial pressure (LAP), pulmonary artery pressure (PAP – systolic and diastolic), central venous and arterial oxygen saturation, urine output, and blood lactate levels].;Primary end point(s): - safety and tolerability: rate of adverse events and routine assessment of laboratory parameters including those for renal function - PK: Css and CL;Timepoint(s) of evaluation of this end point: -safety and tolerability: during the entire duration of the study -PK: Children in age cohorts 1-3 (1 month - <18 years): baseline (0), 2, 16, 22, 32, 40, 48 hours; post infusion 0.5, 4, 8 hours and day 28 Children in age cohort 4 (birth to <1 month): 16, 22, 32, 48 hr; post infusion 0.5, 4, 8 hr and if blood volume will allow, additional samples will be taken during the infusion at baseline, 2 and 40 hr and post infusion at day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): arterial BP and central venous pressure (CVP), left atrial pressure (LAP), pulmonary artery pressure (PAP – systolic and diastolic), central venous and arterial oxygen saturation, urine output and blood lactate levels.;Timepoint(s) of evaluation of this end point: at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion | — |
Countries
Germany, Switzerland, United Kingdom, United States
Contacts
Public ContactMedical Competence Center
Novartis Pharma GmbH - Medizinischer Infoservice
Outcome results
None listed