Skip to main content
OpenTrials
Completed

NCT Number: NCT00729222

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: placebo

Drug

rolofylline placebo IV infusion over 4 hours.

rolofylline

Drug

rolofylline 30 mg IV infusion over 4 hours.

Primary outcomes

  1. change in pulmonary capillary wedge pressure

    Time frame: from baseline to 4 and 8 hours

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • NovaCardia, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2008
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.