Clinical trial NCT04755842: Tricuspid RegUrgitaTion Hamburg Cohort
Official title: Tricuspid Regurgitation Hamburg Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Tricuspid Regurgitation Hamburg Cohort (TRUTH) aims to monitor patients with severe TR, irrespective of the underlying etiology or therapeutic approach.

Brief summary: 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.


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

Primary outcomes:
measure: All-cause mortality
timeFrame: 6-60 months
measure: Cardiovascular mortality
timeFrame: 6-60 months
measure: Rehospitalization for congestive heart failure
timeFrame: 6-60 months
measure: Unplanned tricuspid valve intervention
timeFrame: 6-60 months
measure: Tricuspid regurgitation severity
timeFrame: 6-60 months
Secondary outcomes:
measure: Change in 6-minute-walking-test (6MWT) distance
timeFrame: 6-60 months
measure: Change in quality of life
timeFrame: 6-60 months
measure: Change in New York Heart Association (NYHA) functional class
timeFrame: 6-60 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
Study officials:
affiliation: University Heart and Vascular Center Hamburg
name: Daniel Kalbacher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart and Vascular Center Hamburg
name: Edith Lubos, MD
role: PRINCIPAL_INVESTIGATOR
References: