Berlin Registry of Right Heart Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Overall mortality
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall mortality
Time Frame: 2 months after intervention
Number of deceased participants after 2 months after intervention
Cardiovascular mortality
Time Frame: 2 months after intervention
Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)
Unscheduled hospitalization for heart failure progression
Time Frame: 2 months after intervention
Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention
Secondary Outcomes
- valve function(2 months after intervention)
- NYHA class(2 months after intervention)
- liver function(2 months after intervention)
- cardiac function(2 months after intervention)
- NTproBNP(2 months after intervention)
- kidney function(2 months after intervention)
- cardiac morphology(2 months after intervention)
Investigators
Prof. Dr. Henryk Dreger
Professor
Charite University, Berlin, Germany