Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF (RELAX-AHF-2)
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|ClinicalTrials.gov Identifier: NCT01870778|
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : October 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Heart Failure||Drug: RLX030 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6566 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients|
|Actual Study Start Date :||October 2, 2013|
|Primary Completion Date :||January 23, 2017|
|Study Completion Date :||February 1, 2017|
Placebo Comparator: Placebo
patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.
Patients will receive continuous intravenous infusion of serelaxin for 48 hours.
- Time to confirmed cardiovascular (CV) death during the follow-up period of 180 days [ Time Frame: From baseline to 180 days ]Time-to-event is computed as the number of days from randomization to CV death.
- Time to worsening of heart failure (WHF) through Day 5 (considering death in the 5-day) [ Time Frame: From Baseline to Day 5 ]Time to event is computed as the number of days from randomization to WHF
- Time to all-cause death through Day 180 [ Time Frame: From baseline to 180 days ]Time to event is computed as the number of days from randomization to all cause death
- Length of total hospital stay (LOS) during the index acute heart failure (AHF) hospitalization [ Time Frame: From baseline to 180 days ]Length of stay will be defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day
- Time to first occurrence of the composite endpoint of CV death or rehospitalization due to heart failure or renal failure through day 180 [ Time Frame: From baseline to 180 days ]Time to first is computed as the number of days from randomization to event of interest
- Length of Intensive Care Unit (ICU) and/or Coronary care unit (CCU) stay for the index AHF hospitalization [ Time Frame: From baselint to 180 days ]Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day
- Change from baseline in congestive signs and symptoms of heart failure through Day 5 [ Time Frame: From baseline to Day 5 ]Change from baseline in congestive signs and symptoms of HF through Day 5 will be analyzed by displaying the change in percentage of patients by treatment and time points for each of the signs and symptoms variables.
- Change from baseline in selected biomarkers from baseline through Day 14 in a subset [ Time Frame: From baseline to Day 14 ]
- Number of patients reported with total adverse events, serious adverse events and death [ Time Frame: For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs. ]To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870778
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|