Transcatheter aortic valve replacement: clinical aspects and ethical considerations.
Matthew L Stone, John A Kern, Robert M Sade
https://pubmed.ncbi.nlm.nih.gov/23176901Actively Recruiting
Phase Not Applicable
Age: 70Years +
All Genders
ID04831957
Hypothyroidism After the TAVI Procedure in Elderly Patients
Led by Universitair Ziekenhuis Brussel · Updated on 2024-12-09
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Aortic stenosis is a common condition as people age, especially after age 75, and can lead to serious symptoms and high mortality without treatment. This research investigates hypothyroidism occurring after trans-catheter aortic valve replacement (TAVI), a less invasive alternative to surgery for high-risk or frail elderly patients. The study aims to prospectively identify how often hypothyroidism develops after TAVI and what factors like thyroid disease or medications might predict it, as well as how hypothyroidism affects patients' overall health and function. The study involves elderly patients undergoing the TAVI procedure, which improves heart function by replacing the aortic valve through a catheter. Before and after TAVI, patients receive diagnostic tests including blood samples to assess thyroid function and iodine exposure. The study monitors thyroid hormone levels and antibodies at baseline and up to 12 weeks post-procedure to detect hypothyroidism and its causes. Researchers also evaluate the impact of hypothyroidism on patients' dependence, cognitive function, mood, mobility, and daily living during the first month after TAVI. Participants will have blood and urine tests at specific intervals to measure thyroid hormones and iodine levels, along with ultrasound imaging of the thyroid. Assessments of physical and mental health are performed before TAVI and one month after to understand hypothyroidism's effects. The main outcomes include how many patients develop hypothyroidism and the role of underlying thyroid conditions or iodine exposure. The study follows patients over several weeks to gather detailed information on thyroid health and related functional changes after TAVI.
CONDITIONS
Brief Title
Hypothyroidism After the TAVI Procedure in Elderly Patients
Who Can Participate
Age: 70Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent provided before any study procedures
- Male or female patients aged 70 years or older
- Patients scheduled to undergo a TAVI procedure
You will not qualify if you...
- No signed, dated, and written informed consent obtained
- Known thyroid dysfunction such as Basedow or Hashimoto disease
- Patients currently taking Lithium, Strumazol, or who had recent radio-iodine treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 12 weeks
Participants undergo thyroid function assessments including blood samples for thyroid hormones and antibodies, thyroid ultrasound, and iodine urine samples before and after the TAVI procedure.
1 visit at baseline and 3 follow-up visits at 4, 8, and 12 weeks
Long-term Monitoring
Duration - 1 month
Participants are monitored to assess the development of hypothyroidism and its impact on dependence level, cognitive function, depression, mobility, and daily living after the TAVI procedure.
2 visits at baseline and 1 month
Trial Site Locations
Total: 1 location
1
UZ brussel
Brussels, Belgium, 1090
Actively Recruiting
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Research Team
N
nathalie Compté, Dr, PhD
B
Bert Bravenboer, Dr, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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