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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00729222

Enrollment

Registered

2008-08-07

Start date

2008-11-30

Completion date

2009-03-31

Last updated

2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DRUGComparator: Placebo

rolofylline placebo IV infusion over 4 hours.

DRUGrolofylline

rolofylline 30 mg IV infusion over 4 hours.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
change in pulmonary capillary wedge pressure	from baseline to 4 and 8 hours

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026