Tricuspid RegUrgitaTion Hamburg Cohort (TRUTH)

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Benedikt Koell, MD; Phone Number: +494074100; Email: b.koell@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Heart and Vascular Center Hamburg
    • Contact: Benedikt Koell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Incidence of death from any cause.	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.	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.	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.	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.	6-60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-minute-walking-test (6MWT) distance	6MWT will be performed by all participants at baseline and at follow-up visits.	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.	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.	6-60 months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Daniel Kalbacher, MD, University Heart and Vascular Center Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TRUTH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No