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Hypothyroidism After the TAVI Procedure in Elderly Patients

Key facts

Where
Brussels, BelgiumSee the site

Where in Belgium

  • UZ BrusselBrussels, BelgiumContact: Nathalie Compté, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Universitair Ziekenhuis Brussel
Trial code
NCT04831957
Record updated
9 December 2024
Original description
Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.Read full original descriptionShow less

Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.

Inclusion: Provision of signed and dated, written Informed Consent prior to any study specific proce-dures; Patient: males and females must be ≥ 70 years old; Patients who will undergo a TAVI procedure.

Exclusion: Patients receiving any of the following: Lithium, Strumazol or a recent treatment of radio-Iode; - No obtained signed, dated and written Informed Consent; Known thyroid dysfunction (for example: Basedow, Hashimoto,...).

ClinicalTrials.gov NCT04831957