Heart FailurePhase 2NCT00729222
Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)
A Phase 2 study testing rolofylline in people with Heart Failure, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- rolofylline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg
Who cannot join
- 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
About this 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
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.
- Conditions
- Heart Failure
- Being tested
- Comparator: Placebo, rolofylline
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: PlaceboDrug
rolofylline placebo IV infusion over 4 hours.
rolofyllineDrug
rolofylline 30 mg IV infusion over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
| 2 | Experimental | rolofylline Receives: Drug: rolofylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pulmonary capillary wedge pressure
Measured: 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
Measured: from baseline to 4 and 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NovaCardia, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729222
- Sponsor's protocol ID
- 7418-503
- Other IDs
- MK7418-503, 2008_532
- Status last verified
- Oct 2015
- First submitted
- 5 Aug 2008
- Last updated
- 20 Oct 2015
- Results posted
- No
Publications
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.
PubMed 20823097
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00729222
- Acronym / sponsor ID
- 7418-503
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- NovaCardia, Inc.
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
| 2 | Experimental | Drug: rolofyllinerolofylline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: Placeborolofylline placebo IV infusion over 4 hours. | Drug | 1 |
| rolofyllinerolofylline 30 mg IV infusion over 4 hours. | Drug | 2 |
Primary outcome
change in pulmonary capillary wedge pressure
Time frame: from baseline to 4 and 8 hours
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Results publication: PubMed 20823097Ponikowski 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rolofylline in people with Heart Failure, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pulmonary capillary wedge pressure (time frame: from baseline to 4 and 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.