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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

rolofylline placebo IV infusion over 4 hours.

2

rolofylline

Group Type EXPERIMENTAL

rolofylline

Intervention Type DRUG

rolofylline 30 mg IV infusion over 4 hours.

Interventions

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Comparator: Placebo

rolofylline placebo IV infusion over 4 hours.

Intervention Type DRUG

rolofylline

rolofylline 30 mg IV infusion over 4 hours.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No