RecruitingNot ApplicableNCT04831957

Hypothyroidism After the TAVI Procedure in Elderly Patients


Sponsor

Universitair Ziekenhuis Brussel

Enrollment

20 participants

Start Date

Jul 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 70 Years

Inclusion Criteria3

  • 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 Criteria3

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

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Interventions

DIAGNOSTIC_TESTAssesment of thyroïd function

Blood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample


Locations(1)

UZ brussel

Brussels, Belgium

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NCT04831957


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