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

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: rolofylline

• Registration Number: NCT00729222
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Study Start: 2008-11
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	rolofylline	rolofylline

Primary Outcome Measures

Name	Time	Method
change in pulmonary capillary wedge pressure	from baseline to 4 and 8 hours

Secondary Outcome Measures

Name	Time	Method
Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure	from baseline to 4 and 8 hours