Tricuspid RegUrgitaTion Hamburg Cohort

NCT04755842 | Recruiting

• 1 other identifier: TRUTH
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change in 6-minute-walking-test (6MWT) distance

  6-60 months

• Change in quality of life

  6-60 months

• Change in New York Heart Association (NYHA) functional class

  6-60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Insufficient knowledge of the German language, to understand study documents and interview without translation
• Physical or psychological incapability to cooperate in the investigation

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Standardized methods for sample collection, processing, and storage, as well as appropriate storage facilities, are established and managed in accordance with the highest scientific and ethical standards. To ensure uniformity, quality, and reproducibility for the collection, processing, and storage of biomaterial, standard operating procedures (SOPs) are implemented. The following biomaterial will be sampled for additional biobanking within study visits, as described above: * Blood (whole blood, serum, plasma (EDTA, citrated,), DNA, RNA, washed erythrocytes * Urine * Tissue/ cells

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Daniel Kalbacher, MD

  University Heart and Vascular Center Hamburg

  PRINCIPAL INVESTIGATOR

• Edith Lubos, MD

  University Heart and Vascular Center Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedikt Koell, MD

CONTACT

+494074100; b.koell@uke.de

Sebastian Ludwig, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 16, 2021
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

DE (1)