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Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
NovaCardia, Inc.
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00729222
First received: August 5, 2008
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  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: rolofylline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Comparator: Placebo
rolofylline placebo IV infusion over 4 hours.
Experimental: 2
rolofylline
 Drug: 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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729222

Sponsors and Collaborators
Merck
NovaCardia, Inc.
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00729222     History of Changes
Other Study ID Numbers: 2008_532, MK7418-503
Study First Received: August 5, 2008
Last Updated: May 28, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
1,3-dipropyl-8-(3-noradamantyl)xanthine
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013