Tricuspid RegurgitationTRUTHNCT04755842
Tricuspid RegUrgitaTion Hamburg Cohort
An observational study of Tricuspid Regurgitation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Tricuspid Regurgitation Hamburg Cohort (TRUTH) aims to monitor patients with severe TR, irrespective of the underlying etiology or therapeutic approach.
Who may be able to join
- 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)
Who cannot join
- Insufficient knowledge of the German language, to understand study documents and interview without translation
- Physical or psychological incapability to cooperate in the investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian Ludwig, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Heart and Vascular Center Hamburg
Hamburg, 20246
Benedikt Koell, MD
About this study
Official title: Tricuspid Regurgitation Hamburg Cohort
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.
- Conditions
- Tricuspid Regurgitation
- Medical subject headings
- Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Incidence of death from any cause.
Measured: 6-60 months
Cardiovascular mortality
Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Measured: 6-60 months
Rehospitalization for congestive heart failure
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.
Measured: 6-60 months
Unplanned tricuspid valve intervention
Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.
Measured: 6-60 months
Tricuspid regurgitation severity
Tricuspid regurgitation (TR) severity measured by transthoracic and transesophageal echocardiography. Assessment of TR severity according to current recommendations for valvular heart disease.
Measured: 6-60 months
Secondary outcomes (3)
Change in 6-minute-walking-test (6MWT) distance
6MWT will be performed by all participants at baseline and at follow-up visits.
Measured: 6-60 months
Change in quality of life
Quality of life will be assessed by a standardized questionnaire [Kansas City Cardiomyopathy Questionnaire [KCCQ]) in all participants at baseline and at follow-up visits (or by phone interviews).
The score is represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and a score of 100 indicates no symptoms, no limitations, and excellent quality of life.
Measured: 6-60 months
Change in New York Heart Association (NYHA) functional class
New York Heart Association [NYHA] functional class (I-IV) will be assessed in all participants at baseline and at follow-up visits (or by phone interviews).
NYHA Class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
NYHA Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
NYHA Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
NYHA Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: 6-60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Kalbacher, MD, Principal investigator, Universitätsklinikum Hamburg-EppendorfEdith Lubos, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755842
- Sponsor's protocol ID
- TRUTH
- Acronym
- TRUTH
- Status last verified
- May 2022
- First submitted
- 7 Feb 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No