NCT00729222

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 heart-failure

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2 heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

August 5, 2008

Last Update Submit

October 19, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • change in pulmonary capillary wedge pressure

    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

    from baseline to 4 and 8 hours

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

2

EXPERIMENTAL

rolofylline

Drug: rolofylline

Interventions

Comparator: PlaceboDRUG

rolofylline placebo IV infusion over 4 hours.

1
rolofyllineDRUG

rolofylline 30 mg IV infusion over 4 hours.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure \>95 mm Hg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ponikowski P, Mitrovic V, O'Connor CM, Dittrich H, Cotter G, Massie BM, Givertz MM, Chen E, Murray M, Weatherley BD, Fujita KP, Metra M. Haemodynamic effects of rolofylline in the treatment of patients with heart failure and impaired renal function. Eur J Heart Fail. 2010 Nov;12(11):1238-46. doi: 10.1093/eurjhf/hfq137. Epub 2010 Sep 7.

    PMID: 20823097RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

rolofylline

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 7, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 20, 2015

Record last verified: 2015-10