Status:

NOT_YET_RECRUITING

VITAL - the Heart Failure With Reduced Ejection Fraction Sub-study

Lead Sponsor:

University College, London

Conditions:

Heart Failure With Reduced Ejection Fraction

Eligibility:

All Genders

19-100 years

Brief Summary

Heart failure affects over 1 million people in the United Kingdom. Approximately 50% have heart failure with reduced ejection fraction (HFrEF), a condition where the heart muscle does not contract pro...

Detailed Description

Heart failure affects over 1 million people in the United Kingdom. Approximately 50% of these people have heart failure with reduced ejection fraction (HFrEF), a condition where the muscle of the hear...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Age: \>18 years old
  • Confirmed indication for CRT-device implantation (heart failure with reduced ejection fraction and dyssynchrony on ECG)
  • Exclusion criteria:
  • Pregnancy
  • Any typical contra-indication to a MRI scan (e.g. ferromagnetic fragments in the body
  • Chronic kidney disease stage 4 or 5)
  • Not able to mobilise (as they will not be able to participate in a 6 minute step test)
  • Extreme frailty or life expectancy \< 6 months
  • Recent myocardial infarction within 3 months
  • Cardiac revascularisation or valve surgery/ implantation within the last 3 months
  • Participation in a trial that includes active treatment
  • Anyone with untreated symptomatic cardiovascular disease or severe hypertension

Exclusion

    Key Trial Info

    Start Date :

    October 1 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2028

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT06534151

    Start Date

    October 1 2024

    End Date

    December 31 2028

    Last Update

    August 2 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Royal Free Hospital NHS Trust (RFH)

    London, United Kingdom