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

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

Official Title
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A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of The Effects of MK7418, Both as Monotherapy and in Combination With Furosemide, On Diuresis and Renal Function in Patients With Congestive Heart Failure (CHF) And Renal Impairment Treated With Oral Loop Diuretics Who Require Hospitalization For Fluid Overload

Conditions
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Congestive Heart Failure, Renal Impairment

Intervention / Treatment
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* Drug: rolofyline
* Drug: Comparator Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rolofyline 2.5 mg IV QD | Drug: rolofyline<br>* rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days<br>* Other names: MK7418;|
| Experimental: 2<br>rolofyline 15 mg IV QD | Drug: rolofyline<br>* rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days<br>* Other names: MK7418;|
| Experimental: 3<br>rolofyline 30 mg IV QD | Drug: rolofyline<br>* rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days<br>* Other names: MK7418;|
| Experimental: 4<br>rolofyline 60 mg IV QD | Drug: rolofyline<br>* rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days<br>* Other names: MK7418;|
| Placebo Comparator: 5<br>placebo for rolofyline IV QD | Drug: Comparator Placebo (unspecified)<br>* Matching placebo for rolofyline IV QD; 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the optimal dose range of intravenous (IV) study medication combination with IV furosemide, with or without other diuretics, in preventing deterioration of renal function in CHF patients |  | 30 Days |