Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?

Study acronym: ELASTOCARDIO2
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2025 → Dec 31, 2026
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from French Cardiology Society

Record History

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  1. Primary and study completion pushed from Dec 31, 2025 to Dec 31, 2026 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 90 → 140 participants
    • Eligibility criteria expanded, about 203 words
    • Secondary endpoints: 2 to 4
  2. Primary completion date: Nov 30, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v8
  3. Primary completion date: Aug 31, 2023 to Nov 30, 2024
    • Study completion date: Aug 31, 2023 to Dec 31, 2024
    v7
  4. Primary and study completion dates: Nov 1, 2021 to Aug 31, 2023
    • Start date: Dec 1, 2019 to Jan 24, 2020
    v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2019 to Dec 1, 2019
    • Site details revised
    v4
  2. Start date: May 1, 2019 to Sep 1, 2019v3
  3. Study description revisedv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of frames per second and provide quantitative mapping of the elasticity of the tissues. This current project aims is to focus on myocardial rigidity in diastole to better assess the function of the heart failure.
Trial Details
NCT Number NCT03895541
Lead Sponsor French Cardiology Society
Conditions
(from sponsor)		 Cardiovascular Diseases in Old Age
Related terms Heart Failure
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov