Berlin Registry of Right Heart Interventions

The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Regurgitation; Tricuspid Regurgitation
• Intervention / Treatment: Device: Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)

Detailed Description

The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most.

Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization.

Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Henryk Dreger, Prof. Dr. med.; Phone Number: +4930450613496; Email: henryk.dreger@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Henryk Dreger, Prof. Dr. med.; Phone Number: +49 (0) 30 450 61 34 96; Email: henryk.dreger@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients after interventional therapy of valvular diseases of the right heart (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin).

Description

Inclusion Criteria:

• Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
• >18 years
• Written, documented consent

Exclusion Criteria:

• Patients in care or unable to consent
• Patients who are unable to comply with follow-up examinations
• Patients who are detained in an institution

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Number of deceased participants after 2 months after intervention	2 months after intervention
Cardiovascular mortality	Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)	2 months after intervention
Unscheduled hospitalization for heart failure progression	Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention	2 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA class	New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients)	2 months after intervention
NTproBNP	Laboratory measurement of NTproBNP 2 months after intervention	2 months after intervention
valve function	Echocardiographic quantification of valve function (proximal isovelocity surface area [PISA] method, effective regurgitant orifice [ERO], vena contracta [VC]) after 2 months after intervention	2 months after intervention
liver function	Laboratory measurement of bilirubin 2 months after intervention	2 months after intervention
kidney function	Laboratory measurement of creatinine 2 months after intervention	2 months after intervention
cardiac function	Echocardiographic measurement of cardiac function (left ventricular ejection fraction, tricuspid anular plane systolic excursion) after 2 months after intervention	2 months after intervention
cardiac morphology	Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention	2 months after intervention

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Pulmonary Valve Insufficiency; Tricuspid Valve Insufficiency
• Other Study ID Numbers: EA1/043/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No