Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure - Full Text View

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: Comparator: Placebo Drug: Comparator: Rolofylline	Phase II

MedlinePlus related topics:

Heart Failure

ChemIDplus related topics:

1,3-Dipropyl-8-(3-noradamantyl)xanthine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official 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

Further study details as provided by Merck:

Primary Outcome Measures:

Change in pulmonary capillary wedge pressure [ Time Frame: from baseline to 4 and 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Comparator: Placebo Rolofylline placebo IV infusion over 4 hours.
2: Experimental Rolofylline	Drug: Comparator: Rolofylline Rolofylline 30 mg IV infusion over 4 hours.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with heart failure and renal impairment
Patient currently using furosemide, with systolic blood pressure >95 mmHg

Exclusion Criteria:

Patient has active infection
Patient has used of diuretic within 3 hours of screening visit
Patient has acute tubular necrosis or severe pulmonary disease
Patient has any heart problems within the last two weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729222

Contacts


Contact: Toll Free Number	1-888-577-8839

Sponsors and Collaborators

Merck

NovoCardia, Inc.

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_532, MK7418-503
First Received:	August 5, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00729222
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Failure

Heart Diseases

1,3-dipropyl-8-(3-noradamantyl)xanthine

Additional relevant MeSH terms:

Natriuretic Agents

Therapeutic Uses

Physiological Effects of Drugs

Diuretics

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Merck NovoCardia, Inc.
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00729222