Tricuspid RegUrgitaTion Hamburg Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tricuspid Regurgitation Hamburg Cohort
Overview
Tricuspid regurgitation (TR) is frequent and has been directly related to high mortality rates. The pathophysiology of TR is mainly functional as it occurs predominantly in the context of left-sided heart disease, pulmonary hypertension, or atrial fibrillation. Surgery is currently the primary treatment option in patients with functional TR. However, isolated tricuspid valve surgery is associated with an intolerable high risk of operative mortality and poor outcomes. New transcatheter options could be used in high-surgical risk patients. However, with often severely dilated annuli with a non-planar and elliptical shape, absence of calcification, and proximity of structures, the tricuspid valve anatomy poses many challenges. Predictors of outcome are yet to be defined in patients with TR in order to improve risk prediction for the different treatment modalities (medical, surgical, interventional). The Tricuspid Regurgitation Hamburg Cohort (TRUTH) aims to monitor patients with relevant TR, irrespective of the underlying etiology or therapeutic approach. In addition to available evidence from previously published clinical trials, elaborate prospective clinical registries, such as TRUTH, that monitor clinical routine and current practice, will be of significant importance to further enhance therapeutic options.
Primary outcome measures
- All-cause mortality [Time frame: 6-60 months]
- Cardiovascular mortality [Time frame: 6-60 months]
- Rehospitalization for congestive heart failure [Time frame: 6-60 months]
- Unplanned tricuspid valve intervention [Time frame: 6-60 months]
- Tricuspid regurgitation severity [Time frame: 6-60 months]
Secondary outcome measures (3)
- Change in 6-minute-walking-test (6MWT) distance [Time frame: 6-60 months]
- Change in quality of life [Time frame: 6-60 months]
- Change in New York Heart Association (NYHA) functional class [Time frame: 6-60 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Heart and Vascular Center Hamburg — Hamburg
Identifiers
NCT: NCT04755842 · TRUTH