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Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00202579
First received: September 12, 2005
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

To evaluate the effects on heart function of ivabradine administered to patients with severe chronic heart failure


Condition Intervention Phase
Heart Failure, Congestive
 Drug: Ivabradine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Effects on Peripheral and Central Haemodynamics Parameters, Safety, and Tolerance of Three-hour Intravenous Perfusion (0.1 mg/kg) of Ivabradine Given to Severe Congestive Heart Failure Patients

Resource links provided by NLM:

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

Further study details as provided by Servier:

Primary Outcome Measures:
  • Haemodynamic parameters
  • Twelve-lead ECG
  • Systolic and diastolic blood pressure

Secondary Outcome Measures:
  • Echocardiography
  • Neurohormones

Estimated Enrollment: 12
Study Start Date: September 2004
Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systolic congestive heart failure
  • sinus rhythm, HR >= 80bpm

Exclusion Criteria:

  • unstable cardiovascular condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202579

Locations
Italy
Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
Study Chair: Luigi Tavazzi, Pr Policlinico San Matteo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00202579     History of Changes
Other Study ID Numbers: CL2-16257-053
Study First Received: September 12, 2005
Last Updated: June 15, 2011
Health Authority: Italy: IRCCS Policlinico San Matteo di Pavia

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013