Hypothyroidism After the TAVI Procedure in Elderly Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- 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
Trial design
Design model
Single group
Treatments tested in this trial
Assesment of thyroïd function
Diagnostic testBlood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patient underwent TAVI procedureOther 1 intervention
Trial outcomes
Primary outcomes
1
to assess prospectively the incidence of hypothyroidism after a TAVI procedure.
Change is value of TSH and fT4,
Time frame
Baseline, at 4-8-12 weeks2
To assess the underlying thyroid disease
Presence of thyroid nodule door ultra sound
Time frame
At baseline3
To assess the influence of iodinated constrast on hypothyroidism
Value of presence of Iodine in urine sample
Time frame
At 4 weeks4
To assess the influence of autoimmune disease on hypothyroidism after TAVI
Anti TPO
Time frame
BaselineSecondary outcomes
1
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on dependence level
Value of dependance through : \- Katz scale (ADL: assessment of activities of daily living): It rates 6 tasks of daily liv-ing (bathing, dressing, toilet, transfer, continence and eating) on a scale from 1 to 4. A low score means absence of dependence, and a high score the maximum of de-pendence for the task
Time frame
Baseline and at 1 month2
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on the cognitive function
Value of MMSE (Mini Mental Status Examination): a 0-30 score of cognitive func-tions,\<25/30 meaning cognitive function impairment
Time frame
Baseline and at 1 month3
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on depression
Value of GDS (geriatric depression scale) a 0-15 score. A score \> 15 means risk for depression
Time frame
Baseline and at 1 month4
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on mobility
Value of mobility through * Tinetti : a 0-28 score : a score \< 26 means mobility problems * Timed up and go : Impaired mobility if \> 12.5s * 4 meter walking speed : risico for sarcopenia if speed \> 0.7m/s
Time frame
Baseline and at 1 monthSponsors and contacts
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Source ClinicalTrials.gov