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NCT00202579 Clinical Trial

Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00202579
Other study ID # CL2-16257-053
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated March 13, 2018
Start date September 2004
Est. completion date February 2006

Study information
Verified date March 2018
Source Servier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- systolic congestive heart failure

- sinus rhythm, HR >= 80bpm

Exclusion Criteria:

- unstable cardiovascular condition

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ivabradine

Locations
Country Name City State
Italy Policlinico San Matteo Pavia

Sponsors (1)
Lead Sponsor Collaborator
Institut de Recherches Internationales Servier

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Haemodynamic parameters
Primary Twelve-lead ECG
Primary Systolic and diastolic blood pressure
Secondary Echocardiography
Secondary Neurohormones
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