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Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure
This study is currently recruiting participants.
Verified by Servier, September 2005
First Received: September 12, 2005   Last Updated: September 13, 2005   History of Changes
Sponsored by: Institut De Recherche International Servier
Information provided by: Servier
ClinicalTrials.gov Identifier: NCT00202579
  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 II

Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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:


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
  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

Contacts
Contact: Gaetano M De Ferrari, Dr +39 03 82 503 972

Locations
Italy
Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Luigi Tavazzi, Pr     + 39 03 82 503 157        
Sponsors and Collaborators
Institut De Recherche International Servier
Investigators
Study Chair: Luigi Tavazzi, Pr Policlinico San Matteo
  More Information

No publications provided

Study ID Numbers: CL2-16257-053
Study First Received: September 12, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00202579     History of Changes
Health Authority: Italy: IRCCS Policlinico San Matteo di Pavia

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2009