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

Merck Sharp & Dohme LLC60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Failure

Interventions

Comparator: PlaceboDRUG

rolofylline placebo IV infusion over 4 hours.

rolofyllineDRUG

rolofylline 30 mg IV infusion over 4 hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change in pulmonary capillary wedge pressure

Time frame: from baseline to 4 and 8 hours

Secondary Outcomes

Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure

Time frame: from baseline to 4 and 8 hours

Data from ClinicalTrials.gov

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