Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure
Sponsor
Institut de Recherches Internationales Servier (Other)
Overall Status
Completed
CT.gov ID
NCT00202579
Collaborator
(none)
12
1
17
0.7
Study Details
Study Description
Brief Summary
To evaluate the effects on heart function of ivabradine administered to patients with severe chronic heart failure
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
12 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date
:
Sep 1, 2004
Actual Study Completion Date
:
Feb 1, 2006
Outcome Measures
Primary Outcome Measures
- Haemodynamic parameters []
- Twelve-lead ECG []
- Systolic and diastolic blood pressure []
Secondary Outcome Measures
- Echocardiography []
- Neurohormones []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
systolic congestive heart failure
-
sinus rhythm, HR >= 80bpm
Exclusion Criteria:
- unstable cardiovascular condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Policlinico San Matteo | Pavia | Italy | 27100 |
Sponsors and Collaborators
- Institut de Recherches Internationales Servier
Investigators
- Study Chair: Luigi Tavazzi, Pr, Policlinico San Matteo
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00202579
Other Study ID Numbers:
- CL2-16257-053
First Posted:
Sep 20, 2005
Last Update Posted:
Mar 15, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: