## Protocol Section
### Identification Module
**NCT ID:** NCT00202579

**Brief Title:** Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

**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

#### Organization Study ID Info
**ID:** CL2-16257-053
#### Organization
**Class:** INDUSTRY
**Full Name:** Servier
### Status Module
#### Completion Date
**Date:** 2006-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-15

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-13

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2004-09

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2005-09-20
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-12
**Study First Submit QC Date:** 2005-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institut de Recherches Internationales Servier

### Description Module

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

### Conditions Module

**Conditions:**

- Heart Failure, Congestive

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 12

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Ivabradine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Haemodynamic parameters

**Measure:** Twelve-lead ECG

**Measure:** Systolic and diastolic blood pressure

#### Secondary Outcomes

**Measure:** Echocardiography

**Measure:** Neurohormones

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* systolic congestive heart failure
* sinus rhythm, HR \>= 80bpm

Exclusion Criteria:

* unstable cardiovascular condition

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pavia

**Country:** Italy

**Facility:** Policlinico San Matteo

**Zip:** 27100

#### Overall Officials

**Official 1:**

**Affiliation:** Policlinico San Matteo

**Name:** Luigi Tavazzi, Pr

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**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.

**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:

* submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** After Marketing Authorisation in EEA or US if the study is used for the approval.

**URL:** http://clinicaltrials.servier.com

### References Module

#### See Also Links

**Label:** Results summary

**URL:** http://clinicaltrials.servier.com/wp-content/uploads/CL2-16257-053_synopsis_report.pdf

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24
