Congestive Heart FailurePhase 2NCT00421746
A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
A Phase 2 study testing Piboserod in people with Congestive Heart Failure, run by Bio-Medisinsk Innovasjon at 17 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Piboserod
- How many people
- 137 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Jan 2006to Jul 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of CHF (NYHA class II-IV)
- Locally determined LVEF < 0.35 (by CMR, echocardiography, LV angiography, or radionuclide cardioangiography)
- Stable sinus rhythm
- Stable evidence based pharmacological treatment for CHF.
Who cannot join
- Unstable patients hospitalised within last 2 weeks
- Baseline prolongation of QTc interval
- Atrial fibrillation at randomisation
- MI or re-vascularisation last 3 months
- Stroke last 3 months.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Denmark8 sites
Rigshospitalet
Copenhagen, 2100
Amager Hospital
Copenhagen, 2300
Bispebjerg Hospital
Copenhagen, 2400
Frederiksberg Hospital
Frederiksberg, 2000
Amtsygehuset i Herlev
Herlev, 2730
Hvidovre Hospital
Hvidovre, 2650
Odense Universitets Hospital
Odense, 5000
Svendborg Sygehus
Svendborg, 5700
Norway6 sites
Østlandske Hjertesenter
Moss, 1530
Fana Hjertesenter
Nesttun, 5221
Rikshospitalet
Oslo, 0027
Ullevål Universitetssykehus
Oslo, 0407
Stavanger Universitetssjukehus
Stavanger
St. Olavs Hospital
Trondheim, 7006
United Kingdom3 sites
Bridlington and District General Hospital
Bridlington, YO16 4QP
Castel Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
Western Infirmary
Glasgow, G11 6NT
About this study
Official title: A Proof of Biological Efficacy Study Assessing the Potential of Piboserod, a Specific 5-HT4 Antagonist, for the Treatment of Symptomatic Congestive Heart Failure on Top of Usual Evidence Based Pharmacological Treatment
The purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.
Read the detailed description
Despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. There is an obvious need for new drugs, especially drugs which may have a different mode of action than the existing ones on the market.
The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.
- Conditions
- Congestive Heart Failure
- Being tested
- Piboserod
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiboserodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
Measured: 6 months
Secondary outcomes (5)
Change in LV systolic and diastolic volume (and/or diameter) by CMR
Measured: 6 months
Change in NYHA functional class
Measured: 6 months
Change in various biomarkers for heart failure
Measured: 6 months
Change in QoL-scores
Measured: 6 months
Change in 6-minute walk distance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startJan 2006
- Study completionJul 2007
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 Congestive Heart FailureStudies of the same condition, open and under way.
- 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
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Medisinsk Innovasjon
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS
- Investigators
- Christian Torp-Pedersen, Dr. Med, Study chair, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421746
- Sponsor's protocol ID
- BMI 001 / SMR-1389
- Status last verified
- Aug 2007
- First submitted
- 11 Jan 2007
- Last updated
- 3 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kjekshus JK, Torp-Pedersen C, Gullestad L, Kober L, Edvardsen T, Olsen IC, Sjaastad I, Qvigstad E, Skomedal T, Osnes JB, Levy FO. Effect of piboserod, a 5-HT4 serotonin receptor antagonist, on left ventricular function in patients with symptomatic heart failure. Eur J Heart Fail. 2009 Aug;11(8):771-8. doi: 10.1093/eurjhf/hfp087. Epub 2009 Jun 30.
PubMed 19567409
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Biological Efficacy Study Assessing the Potential of Piboserod, a Specific 5-HT4 Antagonist, for the Treatment of Symptomatic Congestive Heart Failure on Top of Usual Evidence Based Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT00421746
- Acronym / sponsor ID
- BMI 001 / SMR-1389
- Conditions
- Congestive Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Bio-Medisinsk InnovasjonIndustry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS
- Study start
- Jan 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Jan 2007 (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 purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.
Detailed description
Despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. There is an obvious need for new drugs, especially drugs which may have a different mode of action than the existing ones on the market.
The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of CHF (NYHA class II-IV)
- Locally determined LVEF < 0.35 (by CMR, echocardiography, LV angiography, or radionuclide cardioangiography)
- Stable sinus rhythm
- Stable evidence based pharmacological treatment for CHF.
Key exclusion criteria (5 listed)
- Unstable patients hospitalised within last 2 weeks
- Baseline prolongation of QTc interval
- Atrial fibrillation at randomisation
- MI or re-vascularisation last 3 months
- Stroke last 3 months.
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 |
|---|---|---|
| Piboserod | Drug | – |
Primary outcome
Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging
Time frame: 6 months
5 secondary outcomes
Change in LV systolic and diastolic volume (and/or diameter) by CMR
Time frame: 6 months
Change in NYHA functional class
Time frame: 6 months
Change in various biomarkers for heart failure
Time frame: 6 months
Change in QoL-scores
Time frame: 6 months
Change in 6-minute walk distance
Time frame: 6 months
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 3 Aug 2007.
- Derived from this study: PubMed 19567409Kjekshus JK, Torp-Pedersen C, Gullestad L, Kober L, Edvardsen T, Olsen IC, Sjaastad I, Qvigstad E, Skomedal T, Osnes JB, Levy FO. Effect of piboserod, a 5-HT4 serotonin receptor antagonist, on left ventricular function in patients with symptomatic heart failure. Eur J Heart Fail. 2009 Aug;11(8):771-8. doi: 10.1093/eurjhf/hfp087. Epub 2009 Jun 30.
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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.
Christian Torp-Pedersen, Dr. Med study chair
Bispebjerg Hospital
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Piboserod in people with Congestive Heart Failure, run by Bio-Medisinsk Innovasjon at 17 sites in 3 countries.
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 4 inclusion and 5 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 3 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Denmark, Norway, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging (time frame: 6 months). 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 NCT00421746, 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 3 Aug 2007.