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NCT Number: NCT04755842

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Benedikt Koell, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 6-60 months

    Incidence of death from any cause.

  2. Cardiovascular mortality

    Time frame: 6-60 months

    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.

  3. Rehospitalization for congestive heart failure

    Time frame: 6-60 months

    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.

  4. Unplanned tricuspid valve intervention

    Time frame: 6-60 months

    Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.

  5. Tricuspid regurgitation severity

    Time frame: 6-60 months

    Tricuspid regurgitation (TR) severity measured by transthoracic and transesophageal echocardiography. Assessment of TR severity according to current recommendations for valvular heart disease.

Secondary outcomes

  1. Change in 6-minute-walking-test (6MWT) distance

    Time frame: 6-60 months

    6MWT will be performed by all participants at baseline and at follow-up visits.

  2. Change in quality of life

    Time frame: 6-60 months

    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.

  3. Change in New York Heart Association (NYHA) functional class

    Time frame: 6-60 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benedikt Koell, MD

CONTACT

[email protected]

+494074100

Sebastian Ludwig, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: TRUTH

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Feb 16, 2021
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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