Berlin Registry of Right Heart Interventions

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04570163
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 42.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation; Pulmonary Regurgitation	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Berlin Registry of Right Heart Interventions
• Actual Study Start Date: Jun 16, 2020
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Overall mortality [2 months after intervention]

   Number of deceased participants after 2 months after intervention

2. Cardiovascular mortality [2 months after intervention]

   Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)

3. 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

1. NYHA class [2 months after intervention]

   New York Heart Association (NYHA) class (to rate dyspnea in heart failure patients)

2. NTproBNP [2 months after intervention]

   Laboratory measurement of NTproBNP 2 months after intervention

3. 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

4. liver function [2 months after intervention]

   Laboratory measurement of bilirubin 2 months after intervention

5. kidney function [2 months after intervention]

   Laboratory measurement of creatinine 2 months after intervention

6. 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

7. cardiac morphology [2 months after intervention]

   Echocardiographic measurement of cardiac morphology (right ventricular and right atrial diameter) after 2 months after intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. Henryk Dreger, Professor, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04570163
• Other Study ID Numbers: EA1/043/20
• First Posted: Sep 30, 2020
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency; Pulmonary Valve Insufficiency

Study Results

No Results Posted as of Mar 9, 2022