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Completed

NCT Number: NCT04570098

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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:

  • What effect does TR have on patients with heart failure?
  • 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Overall mortality

    Time frame: 3 months after enrolment

    Overall mortality after 3 months (number of deceased patients)

  2. Overall mortality

    Time frame: 24 months after enrolment

    Overall mortality after 24 months (number of deceased patients)

Secondary outcomes

  1. hospitalization due to cardiac decompensation

    Time frame: 3 months after enrolment

    number of hospitalized patients after 3 months

  2. exercise capacity according to NYHA classification

    Time frame: 3 months after enrolment

  3. hospitalization due to cardiac decompensation

    Time frame: 24 months after enrolment

    number of hospitalized patients after 24 months

  4. exercise capacity according to NYHA classification

    Time frame: 24 months after enrolment

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2020
Registry last updated
Feb 12, 2025

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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