Monitoring patients with severe tricuspid regurgitation in Hamburg
Official title: Tricuspid Regurgitation Hamburg Cohort
Run by Universitätsklinikum Hamburg-Eppendorf · NCT04755842 · Data updated 2026-11-12
This study is looking at patients with serious tricuspid regurgitation to see what factors can help predict their health outcomes and improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | June 1, 2020 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | May 31, 2022 |
| Trial ID | NCT04755842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals over 18 years old with clinically relevant tricuspid regurgitation of at least Grade III.
✕Probably not a fit
Patients who are unable to understand the study documents due to language barriers or those who cannot cooperate due to physical or psychological issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with clinically relevant tricuspid regurgitation (TR), a condition linked to high mortality rates. It aims to identify predictors of outcomes in patients suffering from TR, particularly in the context of left-sided heart disease, pulmonary hypertension, or atrial fibrillation. The study will monitor these patients to improve risk prediction for various treatment options, including medical, surgical, and interventional approaches. The research is conducted at the University Heart and Vascular Center Hamburg.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies and outcomes for patients with severe tricuspid regurgitation.
How similar studies have gone: While the study addresses a significant clinical issue, the approach of monitoring and defining predictors in this specific cohort is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation. * Individuals over the age of 18 years. * Patients with clinically relevant tricuspid regurgitation (≥ severe TR, at least Grade III of V) Exclusion Criteria: * Insufficient knowledge of the German language, to understand study documents and interview without translation * Physical or psychological incapability to cooperate in the investigation
Where it's running
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University Heart and Vascular Center Hamburg
Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Daniel Kalbacher, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Benedikt Koell, MD
- Email: b.koell@uke.de
- Phone: +494074100
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
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Compare leadless and left bundle branch pacemakers for heart and valve function
This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.
-
TriClip for treating tricuspid regurgitation in Japan
This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.
-
Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults
This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
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TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation
This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.
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Pivot Extend device to treat severe tricuspid regurgitation
This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.