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
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
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
This Phase IIIb outcome study in AHF patients was designed as a multicenter, randomized, double-blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. The AHF patients randomized to either serelaxin or placebo in the study were followed for a period of 180 days, and were required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards.
Key Inclusion Criteria:
Male or female 18 years of age, with body weight ≤160 kg
Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department) and the end of screening:
Systolic BP ≥125 mmHg at the start and at the end of screening
Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode.
Key Exclusion Criteria:
CABA, Buenos Aires C1180AAX, Argentina
Caba, Buenos Aires C1280AEB, Argentina
Copenhagen NV, DK-2400, Denmark
Saint Herblain - Nantes, 44093, France
Koeln-Nippes, 50733, Germany
Lower Galilee, Israel 15208, Israel
Sefad, 13100, Israel
Tel Giborim, Holon, 58100, Israel
Lódz, 91-347, Poland
Carnaxide - Linda-A-Velha, Lisbon District 2790-134, Portugal
Tg. Mures, Mureș County 540136, Romania
S.-Petersburg, 192242, Russia
S.-Petersburg, 196247, Russia
S.-Petersburg, 198205, Russia
Western Cape, 7130, South Africa
Pendik / Istanbul, Turkey 34899, Turkey (Türkiye)
Haydarpasa/Istanbul, 34668, Turkey (Türkiye)