Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/12/2017
Start Date:October 2, 2013
End Date:February 1, 2017

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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 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 is 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 will be followed for a period of 180 days, and
are 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 requirment 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:

- Persistent dyspnea at rest or with minimal exertion

- Pulmonary congestion on chest radiograph

- BNP ≥500 pg/mL or NT-proBNP ≥2000 pg/mL; for patients ≥ 75 years of age or with
current atrial fibrillation (at the time of randomization), BNP ≥ 750 pg/mL or
NT-proBNP ≥ 3,000 pg/mL

- 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:

- Dyspnea primarily due to non-cardiac causes

- Known history of respiratory disorders requiring the daily use of IV or oral steroids
(does not include inhaled steroids); need for intubation or the current use of IV or
oral steroids for COPD

- Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV
anti-microbial treatment

- Clinical evidence of acute coronary syndrome currently or within 30 days prior to
enrollment.

- AHF due to significant arrhythmias, which include any of the following: sustained
ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per
minute, or atrial fibrillation/flutter with sustained ventricular response of >130
beats per minute

- Patients with severe renal impairment defined as pre-randomization eGFR < 25
mL/min/1.73m2 calculated using the sMDRD equation, and/or those receiving current or
planned dialysis or ultrafiltration

- Patients with hematocrit <25%, or a history of blood transfusion within the 14 days
prior to screening, or active life-threatening GI bleeding.

- Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased
ammonia levels, if performed) or history of cirrhosis with evidence of portal
hypertension such as varices.

- Significant, uncorrected, left ventricular outflow obstruction, such as obstructive
hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0
cm2 or mean gradient >40 mmHg on prior or current echocardiogram), and severe mitral
stenosis

- Severe aortic insufficiency or severe mitral regurgitation for which surgical or
percutaneous intervention is indicated.

- Documented, prior to or at the time of randomization, restrictive amyloid
myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or
constrictive cardiomyopathy (does NOT include restrictive mitral filling patterns seen
on Doppler echocardiographic assessments of diastolic function).
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