Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaCardia, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Rolofylline

Criteria

Inclusion Criteria:

• Be able to provide written informed consent,

• Be a male or female at least 18 years of age,

• Be hospitalized for fluid overload requiring IV diuretic therapy

• History of use of diuretic therapy for CHF (including this admission),

• Be admitted to the hospital within 36 hours of the mandatory dose of IV furosemide 40 mg at between 2000 and 2200 hour on Day -1

Exclusion Criteria:

• Have had a myocardial infarction within 30 days prior to Day -1

• Be pregnant or breast-feeding

• Have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy

• Have had implantation of an automated implanted cardiac defibrillator (AICD) or synchronization device within the preceding 7 days

• Currently require mechanical ventilation, ultrafiltration, or hemodialysis,

• Have symptomatic ventricular tachycardia

• Be admitted for heart transplant surgery or have had a heart transplant,

• Have any other concomitant life-threatening disease,

• Have participated in a clinical trial of an investigational drug or device within 30 days before randomization

• Have a positive urine pregnancy test (for women of child-bearing capacity)

• Have an allergy to soybean oil and/or eggs