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

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ClinicalTrials.gov Identifier: NCT04570098
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Henryk Dreger, Charite University, Berlin, Germany

Study Description
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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
Tricuspid Regurgitation Heart Failure

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
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Study Type : Observational
Estimated 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 : July 26, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population include patients with heart failure (all three entities). All patients will be examined with an echocardiography at the Charité, followed by long-term observation to assess the prognostic relevance of tricuspid regurgitation in heart failure.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570098


Locations
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Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Henryk Dreger, Prof. Dr. med.    +49 (0) 30 450 61 34 96    henryk.dreger@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Prof. Dr. Henryk Dreger, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04570098    
Other Study ID Numbers: EA1/178/19
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As part of the expected publications, it is planned to provide data of the study participants and more detailed information on inclusion and exclusion criteria (study protocol).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases