Hypothyroidism After the TAVI Procedure in Elderly Patients

NCT04831957 | Recruiting DMC

• 1 other identifier: UZCompte3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypothyroidism; TAVI

Keywords

Hypothyroidism; TAVI

Outcome Measures

Primary Outcomes (5)

• to assess prospectively the incidence of hypothyroidism after a TAVI procedure.

  Change is value of TSH and fT4,

  Baseline, at 4-8-12 weeks

• To assess the underlying thyroid disease

  Presence of thyroid nodule door ultra sound

  At baseline

• To assess the influence of iodinated constrast on hypothyroidism

  Value of presence of Iodine in urine sample

  At 4 weeks

• To assess the influence of autoimmune disease on hypothyroidism after TAVI

  Anti TPO

  Baseline

• To assess the influence of presence of antibodies on hypothyroidism after TAVI

  Anti TG

  Baseline

Secondary Outcomes (5)

• to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on dependence level

  Baseline and at 1 month

• to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on the cognitive function

  Baseline and at 1 month

• to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on depression

  Baseline and at 1 month

• to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on mobility

  Baseline and at 1 month

• to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on instrumental daily living

  Baseline and at 1 month

Study Arms (1)

Patient underwent TAVI procedure

OTHER

\- Elderly patients who will undergo a TAVI procedure coming to the geriatric day hospital

Diagnostic Test: Assesment of thyroïd function

Interventions

Assesment of thyroïd function DIAGNOSTIC_TEST

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

Patient underwent TAVI procedure

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ brussel

Brussels, 1090, Belgium

RECRUITING

Related Publications (5)

• Stone ML, Kern JA, Sade RM. Transcatheter aortic valve replacement: clinical aspects and ethical considerations. Ann Thorac Surg. 2012 Dec;94(6):1791-5. doi: 10.1016/j.athoracsur.2012.09.047. No abstract available.

  PMID: 23176901 BACKGROUND

• Leontyev S, Walther T, Borger MA, Lehmann S, Funkat AK, Rastan A, Kempfert J, Falk V, Mohr FW. Aortic valve replacement in octogenarians: utility of risk stratification with EuroSCORE. Ann Thorac Surg. 2009 May;87(5):1440-5. doi: 10.1016/j.athoracsur.2009.01.057.

  PMID: 19379882 BACKGROUND

• Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

  PMID: 22443479 BACKGROUND

• Leung AM, Braverman LE. Iodine-induced thyroid dysfunction. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):414-9. doi: 10.1097/MED.0b013e3283565bb2.

  PMID: 22820214 BACKGROUND

• Trohman RG, Sharma PS, McAninch EA, Bianco AC. Amiodarone and thyroid physiology, pathophysiology, diagnosis and management. Trends Cardiovasc Med. 2019 Jul;29(5):285-295. doi: 10.1016/j.tcm.2018.09.005. Epub 2018 Sep 20.

  PMID: 30309693 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

nathalie Compté, Dr, PhD

CONTACT

024749159; nath_compte@hotmail.com

Bert Bravenboer, Dr, PhD

CONTACT

024749512; bert.Bravenboer@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic head of geriatric unit

Model Details: Academic trial, prospective study

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 5, 2021
• Study Start: July 26, 2021
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)