A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421746
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : August 3, 2007
Smerud Medical Research International AS
Information provided by:
Bio-Medisinsk Innovasjon

Brief 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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Piboserod Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in LV systolic and diastolic volume (and/or diameter) by CMR [ Time Frame: 6 months ]
  2. Change in NYHA functional class [ Time Frame: 6 months ]
  3. Change in various biomarkers for heart failure [ Time Frame: 6 months ]
  4. Change in QoL-scores [ Time Frame: 6 months ]
  5. Change in 6-minute walk distance [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421746

Copenhagen, Denmark, 2100
Amager Hospital
Copenhagen, Denmark, 2300
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Amtsygehuset i Herlev
Herlev, Denmark, 2730
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense Universitets Hospital
Odense, Denmark, 5000
Svendborg Sygehus
Svendborg, Denmark, 5700
Østlandske Hjertesenter
Moss, Norway, 1530
Fana Hjertesenter
Nesttun, Norway, 5221
Oslo, Norway, 0027
Ullevål Universitetssykehus
Oslo, Norway, 0407
Stavanger Universitetssjukehus
Stavanger, Norway
St. Olavs Hospital
Trondheim, Norway, 7006
United Kingdom
Castel Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Bridlington and District General Hospital
Bridlington, United Kingdom, YO16 4QP
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Bio-Medisinsk Innovasjon
Smerud Medical Research International AS
Study Chair: Christian Torp-Pedersen, Dr. Med Bispebjerg Hospital, Copenhagen, Denmark

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00421746     History of Changes
Other Study ID Numbers: BMI 001 / SMR-1389
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: August 3, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases