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Hypothyroidism After the TAVI Procedure in Elderly Patients

Primary Purpose

Hypothyroidism, TAVI

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Assesment of thyroïd function
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypothyroidism focused on measuring Hypothyroidism, TAVI

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • - 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

Sites / Locations

  • UZ brusselRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient underwent TAVI procedure

Arm Description

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

Outcomes

Primary Outcome Measures

to assess prospectively the incidence of hypothyroidism after a TAVI procedure.
Change is value of TSH and fT4,
To assess the underlying thyroid disease
Presence of thyroid nodule door ultra sound
To assess the influence of iodinated constrast on hypothyroidism
Value of presence of Iodine in urine sample
To assess the influence of autoimmune disease on hypothyroidism after TAVI
Anti TPO
To assess the influence of presence of antibodies on hypothyroidism after TAVI
Anti TG

Secondary Outcome Measures

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
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
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
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
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on instrumental daily living
- lawton scale (assessment of instrumentary assessment of activities of daily living) a 0-27 score; a high score means independence; a low score means dependence

Full Information

First Posted
March 19, 2021
Last Updated
May 10, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04831957
Brief Title
Hypothyroidism After the TAVI Procedure in Elderly Patients
Official Title
Hypothyroidism After the TAVI Procedure in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Aortic stenosis is highly prevalent in advancing age. The prevalence is 2.5% at an age of 75 years and 8.1% at an age of 85 years. The estimated mortality after onset of symptoms (dizziness, syncope, thoracic pain and dyspnea) with conventional medical treatment is 75% after 3 years follow up. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve. However, an open surgical procedure is not always possible in high risk patients for anatomical reasons (sternotomy, radiation and chest deformation) or comorbidities defined by the Euroscore and the Society of Thoracic Surgeons' risk score (STS score). Trans-catheter aortic valve replacement (TAVI) is becoming the standard care of patients suffering of non-operable, high risk severe and symptomatic aortic stenosis. The TAVI procedure is associated with immediate hemodynamic improvement characterized by a decreased aortic valve mean pressure gradient, an improved left ventricular end systolic volume and mass, a decreased end ventricular diastolic volume and a better ejection fraction. This hemodynamic improvement translates into better clinical outcomes. Mortality rates (2.2% and 6.7% at one month and at one year) and long term stroke rate are similar after TAVI or surgical replacement. The TAVI procedure is also successful in octogenarian and in frail patients. Consequently, patient's frailty is a growing argument to refer the patient for a percutaneous treatment of valve disease instead of a conventional surgical approach. The standard evaluation before the TAVI procedure comprises some radiologic studies with iodinated contrast agent (coronarography, thoracic CT scanner and the TAVI procedure itself). Furthermore, some patients require a treatment with Amiodarone® because of the occurrence of atrial fibrillation during the procedure. A typical iodinated contrast study confers 13500 µg of free iodine and 15-60g of bound iodine (several hundred thousand times above the recommended daily intake). An excess of iodium expo-sure can lead to thyroid dysfunction: Hyperthyroidism particularly in patients with underlying nodular thyroid disease (Jod-Basedow effect). Hypothyroidism in patients with underlying thyroid disease or in patients who are taking medication (lithium, amiodarone) which can lead to thyroid dysfunction. The mechanism of iodinated contrast agent hypothyroidism is the failure to escape of the acute Wolf-Chaikoff effect. Amiodarone confers 3-21 mg iodine daily and can also lead to thyroid dysfunction particularly in patients with underlying thyroid disease because of the failure to escape of the acute Wolf-Chaikoff effect. An autoimmune mechanism is also described. Epidemiology In our recent clinical practice (geriatric day hospital UZ Brussel), an increased incidence of hypothyroidism in elderly patients after a TAVI procedure has been observed. In our knowledge, there are no data about the incidence of hypothyroidism and what could be the impact for elderly patients after a TAVI procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, TAVI
Keywords
Hypothyroidism, TAVI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Academic trial, prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient underwent TAVI procedure
Arm Type
Other
Arm Description
- Elderly patients who will undergo a TAVI procedure coming to the geriatric day hospital
Intervention Type
Diagnostic Test
Intervention Name(s)
Assesment of thyroïd function
Intervention Description
Blood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample
Primary Outcome Measure Information:
Title
to assess prospectively the incidence of hypothyroidism after a TAVI procedure.
Description
Change is value of TSH and fT4,
Time Frame
Baseline, at 4-8-12 weeks
Title
To assess the underlying thyroid disease
Description
Presence of thyroid nodule door ultra sound
Time Frame
At baseline
Title
To assess the influence of iodinated constrast on hypothyroidism
Description
Value of presence of Iodine in urine sample
Time Frame
At 4 weeks
Title
To assess the influence of autoimmune disease on hypothyroidism after TAVI
Description
Anti TPO
Time Frame
Baseline
Title
To assess the influence of presence of antibodies on hypothyroidism after TAVI
Description
Anti TG
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on dependence level
Description
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 month
Title
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on the cognitive function
Description
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 month
Title
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on depression
Description
Value of GDS (geriatric depression scale) a 0-15 score. A score > 15 means risk for depression
Time Frame
Baseline and at 1 month
Title
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on mobility
Description
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 month
Title
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on instrumental daily living
Description
- lawton scale (assessment of instrumentary assessment of activities of daily living) a 0-27 score; a high score means independence; a low score means dependence
Time Frame
Baseline and at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: - 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nathalie Compté, Dr, PhD
Phone
024749159
Ext
9159
Email
nath_compte@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bert Bravenboer, Dr, PhD
Phone
024749512
Ext
9512
Email
bert.Bravenboer@uzbrussel.be
Facility Information:
Facility Name
UZ brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Compté, PhD
Phone
024749159
Ext
9159
Email
nath_compte@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bert Bravenboer, PhD
Phone
024749512
Ext
9512
Email
bert.bravenboer@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no sharing plan
Citations:
PubMed Identifier
23176901
Citation
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.
Results Reference
background
PubMed Identifier
19379882
Citation
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.
Results Reference
background
PubMed Identifier
22443479
Citation
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.
Results Reference
background
PubMed Identifier
22820214
Citation
Leung AM, Braverman LE. Iodine-induced thyroid dysfunction. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):414-9. doi: 10.1097/MED.0b013e3283565bb2.
Results Reference
background
PubMed Identifier
30309693
Citation
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.
Results Reference
background

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Hypothyroidism After the TAVI Procedure in Elderly Patients

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