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Completed

NCT Number: NCT02441218

Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study

The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Pitié-Salpétrière, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic Chronic heart failure (NYHA II, III or IV)
  • Left ventricular systolic dysfunction (LVEF ≤ 35%)
  • Sinus rhythm and resting heart rate ≥ 70 bpm
  • Optimal and unchanged CHF medications or dosages

Exclusion criteria

  • Unstable condition within previous 4 weeks
  • Myocardial infarction or coronary revascularisation within previous 2 months
  • Stroke or transient cerebral ischaemia within previous 4 weeks
  • Congenital heart disease
  • Severe valvular disease
  • Active myocarditis
  • Permanent atrial fibrillation or flutter

Treatment and study plan

Ivabradine

Drug

2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.

Placebo

Drug

Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.

Primary outcomes

  1. Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.

    Time frame: All over the study (up to 42 months).

    Number of patients having experienced the Primary Composite Endpoint.

Secondary outcomes

  1. Cardiovascular Death

    Time frame: From the date of randomization until the date of death, up to 42 months

    Component of the primary composite endpoint

  2. Hospitalisation for Worsening Heart Failure

    Time frame: From the date of randomization to the date of first documented hospitalisation, up to 42 months

  3. All-cause Mortality

    Time frame: From the date of randomisation to death, up to 42 months.

  4. Death From Heart Failure

    Time frame: From the date of randomisation to death, up to 42 months.

    Component of cardiovascular death

  5. Hospitalisation for Any Cause

    Time frame: From the date of randomisation to the date of first documented hospitalisation, up to 42 months

  6. Hospitalisation for Cardiovascular Reason

    Time frame: From the date of randomisation to the first documented hospitalisation, up to 42 months

  7. Unplanned Hospitalisation for Any Cause

    Time frame: From the date of randomisation to the first documented hospitalisation, up to 42 months

  8. Unplanned Hospitalisation for CV Reason

    Time frame: From the date of randomisation to the first documented hospitalisation, up to 42 months.

  9. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of the first event, up to 42 months

    CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Acronym: SHIFT

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 12, 2015
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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