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Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT04570098
Collaborator
(none)
1,000
Enrollment
1
Location
41.2
Anticipated Duration (Months)
24.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Moderate to severe tricuspid regurgitation (TR) is a frequent result of left heart failure causing a limiting prognosis. The new interventional therapies have given more relevance to the questions of the prognostic significance of severe TR in the various heart failure entities.

    Important but currently unanswered questions for the establishment of successful, interventional therapies of TR are:

    1. What effect does TR have on patients with heart failure?

    2. Which patients at which stage of the disease benefit from interventional TR-therapies? In order to answer these questions, the aim of the study is to prospectively record the prevalence of TR (including quantification) in all heart failure patients at the Charité, followed by long-term observation to assess its prognostic relevance.

    In addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. A comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies.

    Primary endpoint: death Secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to NYHA classification

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
    Actual Study Start Date :
    Jul 26, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Overall mortality [3 months after enrolment]

      Overall mortality after 3 months (number of deceased patients)

    2. Overall mortality [24 months after enrolment]

      Overall mortality after 24 months (number of deceased patients)

    Secondary Outcome Measures

    1. hospitalization due to cardiac decompensation [3 months after enrolment]

      number of hospitalized patients after 3 months

    2. exercise capacity according to NYHA classification [3 months after enrolment]

    3. hospitalization due to cardiac decompensation [24 months after enrolment]

      number of hospitalized patients after 24 months

    4. exercise capacity according to NYHA classification [24 months after enrolment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with transthoracic echocardiography (TTE) and heart failure

    • Reported heart failure symptoms within the last two years

    • 18 years

    • Written, documented consent

    Exclusion Criteria:
    • Patients in care or unable to consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité - Universitätsmedizin Berlin Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Henryk Dreger, Professor, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT04570098
    Other Study ID Numbers:
    • EA1/178/19
    First Posted:
    Sep 30, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Tricuspid Valve Insufficiency

    Study Results

    No Results Posted as of Mar 9, 2022