Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: rolofylline; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00729222

7418-503

MK7418-503

2008_532

Details and patient eligibility

About

The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg

Exclusion criteria

• Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo

2

Experimental group

Description:

rolofylline

Treatment:

Drug: rolofylline