Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2014
End Date:September 2015

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Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

The purpose of this study is to assess the safety of repeat doses of serelaxin in chronic
heart failure. At the same time, markers of efficacy will also be collected as exploratory
measures.


Inclusion Criteria:

- Body weight of ≤ 160 kg.

- Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior
documented history of chronic heart failure.

- NT-proBNP >300 pg/ml (according to central measurement) at visit 1.

- Subjects treated with appropriate and guideline-indicated CHF standard of care.

- Ability to comply with all requirements, including ability to receive at least a 48
hour infusion plus follow-up time required for each dosing visit.

Exclusion Criteria:

- Current acute decompensated HF

- Any major solid organ transplant recipient or planned anticipated organ transplant
within 1 year.

- Documented history of untreated ventricular arrhythmia with syncopal episodes,
ventricular tachycardia, or ventricular fibrillation without ICD (implantable
cardioverter defibrillator) with significant hemodynamic consequences within the 3
months prior to screening.

- Presence of hemodynamically significant mitral and /or aortic valve disease, except
mitral regurgitation secondary to left ventricular dilatation: including significant
left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy,
severe aortic stenosis)

- Subjects with severe renal impairment defined as pre-randomization eGFR < 30
ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or
planned dialysis or ultrafiltration

Other protocol defined inclusion/exclusion criteria may apply.
We found this trial at
10
sites
Richmond, Virginia 23249
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Anaheim, California 92801
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Anaheim, CA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Geelong, Victoria 3220
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Geelong,
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Jacksonville, Florida 32216
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Jacksonville, FL
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Knoxville, Tennessee 37934
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Knoxville, TN
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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South Miami, Florida 33143
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South Miami, FL
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