NCT04570098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4.2 years

First QC Date

September 20, 2020

Last Update Submit

February 10, 2025

Conditions

Tricuspid RegurgitationHeart Failure

Outcome Measures

Primary Outcomes (2)

  • Overall mortality

    Overall mortality after 3 months (number of deceased patients)

    3 months after enrolment

  • Overall mortality

    Overall mortality after 24 months (number of deceased patients)

    24 months after enrolment

Secondary Outcomes (4)

  • hospitalization due to cardiac decompensation

    3 months after enrolment

  • exercise capacity according to NYHA classification

    3 months after enrolment

  • hospitalization due to cardiac decompensation

    24 months after enrolment

  • exercise capacity according to NYHA classification

    24 months after enrolment

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients with transthoracic echocardiography (TTE) and heart failure
  • Reported heart failure symptoms within the last two years
  • \>18 years
  • Written, documented consent

You may not qualify if:

  • \- Patients in care or unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2020

First Posted

September 30, 2020

Study Start

July 26, 2020

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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).

Locations

DE(1)