Pharmacokinetic and safety of serelaxin when added to standard of care in pediatric patients hospitalized with acute heart failure

Phase 1

• Conditions: acute heart failure; MedDRA version: 19.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002847-28-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-28
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 <18 years of age, with body weight =2.5 kg to =120 kg
3. Hospitalized in an intensive/critical care unit or continuously monitored step-down unit with the following:
a) signs and symptoms of AHF of any etiology
b) a stable dose of vasoactive and/or inotropic agents
c) for non-surgical patients (medical etiologies of AHF), echocardiographic evidence of reduced ventricular function is required as follows:
i.Ejection fraction of the systemic or pulmonary ventricle <50% in patients with systemic left ventricular dysfunction, or
ii.Fractional shortening <28% in patients with systemic left ventricular dysfunction, or
iii.Qualitative evidence of a dilated ventricle with at least mild systemic ventricular systolic dysfunction in patients with right ventricular or single ventricular physiology
4. Systolic blood pressure (SBP) consistently equal to or greater than the calculated 25th percentile SBP for age and gender per the protocol.
5. Stable pulmonary function, i.e. patient is extubated or is stable on ventilator support.

Additional details are listed in the clinical study protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 < 36 weeks post-conceptual age (applies only to children <1year old at baseline)
8. Confirmed or clinically suspected systemic infection (sepsis) or severe localized infection requiring iv antibiotics
9. Dyspnea or acute lung injury primarily due to non-cardiac causes
10. Patients with severe renal impairment, those known to have significant renal disease and those having current or planned renal replacement therapy
11. Excessive use of inotropic and/or vasoactive agents at screening (vasoactive score >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified