HypothyroidismNCT04831957
Hypothyroidism After the TAVI Procedure in Elderly Patients
A study testing Assesment of thyroïd function in people with Hypothyroidism and TAVI, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hypothyroidism, TAVI
- What is being tested?
- Assesment of thyroïd function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jul 2021to 31 Dec 2050
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- - 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ brussel
Brussels, 1090
Nathalie Compté, PhD, 024749159 ext. 9159, nath_compte@hotmail.com
Bert Bravenboer, PhD, 024749512 ext. 9512, bert.bravenboer@uzbrussel.be
About this study
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 the 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.
- Conditions
- Hypothyroidism, TAVI
- Being tested
- Assesment of thyroïd function
- Keywords
- Hypothyroidism, TAVI
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of thyroïd functionDiagnostic test
Blood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample
| Study group | Role | What they receive |
|---|---|---|
| Patient underwent TAVI procedure | Other | - Elderly patients who will undergo a TAVI procedure coming to the geriatric day hospital Receives: Diagnostic Test: Assesment of thyroïd function |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess prospectively the incidence of hypothyroidism after a TAVI procedure.
Change is value of TSH and fT4,
Measured: Baseline, at 4-8-12 weeks
To assess the underlying thyroid disease
Presence of thyroid nodule door ultra sound
Measured: At baseline
To assess the influence of iodinated constrast on hypothyroidism
Value of presence of Iodine in urine sample
Measured: At 4 weeks
To assess the influence of autoimmune disease on hypothyroidism after TAVI
Anti TPO
Measured: Baseline
To assess the influence of presence of antibodies on hypothyroidism after TAVI
Anti TG
Measured: Baseline
Secondary outcomes (5)
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
Measured: Baseline and at 1 month
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
Measured: Baseline and at 1 month
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
Measured: Baseline and at 1 month
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
Measured: Baseline and at 1 month
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
Measured: Baseline and at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start26 Jul 2021
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Academic trial, prospective study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie compté, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831957
- Sponsor's protocol ID
- UZCompte3
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing plan
Publications
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.
PubMed 23176901Leontyev 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.
PubMed 19379882Kodali 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.
PubMed 22443479Leung AM, Braverman LE. Iodine-induced thyroid dysfunction. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):414-9. doi: 10.1097/MED.0b013e3283565bb2.
PubMed 22820214Trohman 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.
PubMed 30309693
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothyroidism After the TAVI Procedure in Elderly Patients
- ClinicalTrials.gov ID
- NCT04831957
- Acronym / sponsor ID
- UZCompte3
- Conditions
- Hypothyroidism, TAVI
- Keywords
- Hypothyroidism, TAVI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Academic trial, prospective study
| Arm | Type | Receives |
|---|---|---|
| Patient underwent TAVI procedure | Other | Diagnostic Test: Assesment of thyroïd function- Elderly patients who will undergo a TAVI procedure coming to the geriatric day hospital |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assesment of thyroïd functionBlood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample | Diagnostic test | Patient underwent TAVI procedure |
Primary outcome
to assess prospectively the incidence of hypothyroidism after a TAVI procedure.
Time frame: Baseline, at 4-8-12 weeks
Change is value of TSH and fT4,
To assess the underlying thyroid disease
Time frame: At baseline
Presence of thyroid nodule door ultra sound
To assess the influence of iodinated constrast on hypothyroidism
Time frame: At 4 weeks
Value of presence of Iodine in urine sample
To assess the influence of autoimmune disease on hypothyroidism after TAVI
Time frame: Baseline
Anti TPO
To assess the influence of presence of antibodies on hypothyroidism after TAVI
Time frame: Baseline
Anti TG
5 secondary outcomes
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on dependence level
Time frame: Baseline and at 1 month
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on the cognitive function
Time frame: Baseline and at 1 month
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on depression
Time frame: Baseline and at 1 month
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on mobility
Time frame: Baseline and at 1 month
to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on instrumental daily living
Time frame: Baseline and at 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 23176901Stone 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.
- Background: PubMed 19379882Leontyev 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.
- Background: PubMed 22443479Kodali 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.
- Background: PubMed 22820214Leung AM, Braverman LE. Iodine-induced thyroid dysfunction. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):414-9. doi: 10.1097/MED.0b013e3283565bb2.
- Background: PubMed 30309693Trohman 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.
- Individual participant dataSharing planned: No. no sharing plan
Related trials for Hypothyroidism
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assesment of thyroïd function in people with Hypothyroidism and TAVI, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nathalie Compté, Dr, PhD (024749159 ext. 9159, nath_compte@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess prospectively the incidence of hypothyroidism after a TAVI procedure. (time frame: Baseline, at 4-8-12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831957, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.