Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00202579 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2018
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure, Congestive | Drug: Ivabradine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | September 2004 |
Actual Study Completion Date : | February 2006 |

- Haemodynamic parameters
- Twelve-lead ECG
- Systolic and diastolic blood pressure
- Echocardiography
- Neurohormones

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- systolic congestive heart failure
- sinus rhythm, HR >= 80bpm
Exclusion Criteria:
- unstable cardiovascular condition

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202579
Italy | |
Policlinico San Matteo | |
Pavia, Italy, 27100 |
Study Chair: | Luigi Tavazzi, Pr | Policlinico San Matteo |
ClinicalTrials.gov Identifier: | NCT00202579 |
Other Study ID Numbers: |
CL2-16257-053 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | March 15, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies:
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Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After Marketing Authorisation in EEA or US if the study is used for the approval. |
Access Criteria: | Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed. |
URL: | http://clinicaltrials.servier.com |
Heart Failure Heart Diseases Cardiovascular Diseases |