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CompletedNCT00202579Updated Jul 25, 2024

Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

A Phase 2 interventional study of Ivabradine in Heart Failure, Congestive, sponsored by Institut de Recherches Internationales Servier. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Institut de Recherches Internationales Servier · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

02

Conditions studied

  • Heart Failure, Congestive

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 12 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Institut de Recherches Internationales Servier is the lead sponsor of 64 studies on the registry; 5 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • unstable cardiovascular condition
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • DrugIvabradine
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What researchers measure

Primary outcomes

  1. Haemodynamic parameters

  2. Twelve-lead ECG

  3. Systolic and diastolic blood pressure

Secondary outcomes

  1. Echocardiography

  2. Neurohormones

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Study locations

1 site
  • Policlinico San Matteo
    Pavia, 27100, Italy
08

References and documents

Related links

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00202579
Lead sponsor
Institut de Recherches Internationales Servier
First posted
Sep 20, 2005
Start date
Sep 2004
Completion
Feb 2006
Last update
Jul 25, 2024

Study contacts

Luigi Tavazzi, Pr
study chair · Policlinico San Matteo
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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