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

This study has been completed.
Sponsor:
Collaborator:
Smerud Medical Research International AS
Information provided by:
Bio-Medisinsk Innovasjon
ClinicalTrials.gov Identifier:
NCT00421746
First received: January 11, 2007
Last updated: August 2, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Congestive Heart Failure
Drug: Piboserod
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Bio-Medisinsk Innovasjon:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 137
Study Start Date: January 2006
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421746

Locations
Denmark
Rigshospitalet
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
Norway
Østlandske Hjertesenter
Moss, Norway, 1530
Fana Hjertesenter
Nesttun, Norway, 5221
Rikshospitalet
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
Investigators
Study Chair: Christian Torp-Pedersen, Dr. Med Bispebjerg Hospital, Copenhagen, Denmark
  More Information

Additional Information:
No publications provided by Bio-Medisinsk Innovasjon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421746     History of Changes
Other Study ID Numbers: BMI 001 / SMR-1389
Study First Received: January 11, 2007
Last Updated: August 2, 2007
Health Authority: Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Serotonin 5-HT4 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014