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Clinical Research Study
Mercy St. Vincent Medical Center


Safety and Efficacy Study to Evaluate the Effect of SLV320
on Renal Function in Patients With Worsening Heart Failure

Sponsored by: Solvay Pharmaceuticals, January 2009

Purpose

The purpose of this study is to determine the efficacy and safety of I.V. SLV320 in acute heart failure patients with renal dysfunction.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • Renal dysfunction defined as estimated eGFR of 20-80 mL/min;
  • History of systolic or diastolic chronic heart failure of at least 14 days duration for which loop diuretic therapy has been prescribed;
  • Clinical evidence for volume overload;
  • BNP > 500 pg/mL or NT-pro-BNP > 2000 pg/mL;
  • Hospitalization
Exclusion Criteria:
  • Have low output syndrome, defined as having the need for treatment with I.V. inotropes or vasopressors;
  • Need mechanical ventilation
  • Have significant stenotic valvular disease (severe aortic or mitral stenosis);
  • Have myocardial infarction or hemodynamically destabilizing significant arrythmias (ventricular tachycardia, bradyarrythmias with slow ventricular rate [<45 bpm] or atrial fibrillation/flutter with a rapid ventricular response of >120 bpm), or electrocardiographic evidence of 2nd degree heart block (Mobitz Type II) or 3rd degree AV-block in the absence of a pacemaker, within 30 days of screening;
  • Have acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy

Contacts

Physicians:
Ameer Kabour, MD
Mohammad Alkhateeb, MD
Raza Hashmi, MD
Tarif Kanaan, MD

Coordinators:
Brenda Hoagland, RN, CCRC
Michelle Hickam, BSN
Julie Neidhardt, BSN

Please contact us at 419-251-4919 for more information about this study.
Click here for Printable copy of trial.
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