Berlin Registry of Right Heart Interventions

Recruiting

• Conditions: Pulmonary Regurgitation; Tricuspid Regurgitation

• Registration Number: NCT04570163
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

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 Timeline

• Study Start: 2020-06-16
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany