|
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.
|