Clinical Trials Logo
  1. Home
  2. Acute Heart Failure
  3. NCT02151383

Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure — RELAX-PEDS-PK  

Acute Heart Failure Clinical Trial

Official title:
Multicenter, Open-label, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of RLX030 in Addition to Standard of Care in Pediatric Patients From Birth to <18 Years of Age, Hospitalized With Acute Heart Failure

Clinical Trial Summary

The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)

Clinical Trial Description

The study was terminated early and the pediatric development of serelaxin in the treatment of acute heart failure (AHF) discontinued, following the results of the phase III study RELAX-AHF-2 (CRLX030A2301/NCT01870778) study in adult patients with AHF. Whilst no new safety concerns associated with serelaxin were observed, the study in adults did not meet either of its primary endpoints ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02151383
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 2
Start date September 5, 2014
Completion date April 3, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT02135835 - A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure Phase 4
Recruiting NCT05556044 - Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction Phase 3
Recruiting NCT04363697 - Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68) Phase 4
Completed NCT02122640 - Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department N/A
Not yet recruiting NCT01211886 - Utility of Brain Natriuretic Peptide (BNP) in Patients With Type IV Cardio-renal Syndrome Admitted to the Intensive Care Unit (ICU) N/A
Completed NCT01193998 - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department N/A
Not yet recruiting NCT06465498 - Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography N/A
Recruiting NCT05276219 - Optimized Treatment of Pulmonary Edema or Congestion Phase 4
Recruiting NCT05392764 - Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure Phase 3
Recruiting NCT03157219 - Manipal Heart Failure Registry (MHFR) N/A
Completed NCT06024889 - Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure. Phase 1/Phase 2
Terminated NCT04174794 - Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial
Recruiting NCT05972746 - Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure N/A
Enrolling by invitation NCT02258984 - Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial N/A
Completed NCT02141607 - Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Completed NCT01870778 - Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF Phase 3
Recruiting NCT05986773 - Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance Phase 4
Recruiting NCT04163588 - Sequential Nephron Blockade in Acute Heart Failure Phase 3
Recruiting NCT04329234 - Korean Heart Failure Registry III
Recruiting NCT03717636 - Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure N/A