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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014