We hypothesize that quick cycling from hypothyroidism to hyperthyroidism in early treatment of DTC has deleterious effects on cardiac function.
ID
Bron
Verkorte titel
Aandoening
Differentiated thyroid carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To compare the effects of hypothyroidism and hyperthyroidism on cardiac left ventricular function, as assessed by CMR, in subjects with differentiated thyroid cancer during their early treatment.
Achtergrond van het onderzoek
The THETA-study is a longitudinal observational study in patients with differentiated thyroid carcinoma. The primary objective is to compare the effects of hypothyroidism and hyperthyroidism on cardiovascular function.
Doel van het onderzoek
We hypothesize that quick cycling from hypothyroidism to hyperthyroidism in early treatment of DTC has deleterious effects on cardiac function.
Onderzoeksopzet
The study will have three main visits, the first visit will be combined with the hospitalisation for regular iodine treatment. The screening visit takes place before radioiodine ablation therapy. Subjects will subsequently be invited at week 0, 10, and 20. Patients with a DTC diagnosis after hemithyroidectomy will be asked to participate in a baseline visit. This visit takes place after hemithyroidectomy and before total thyroidectomy, during euthyroidism.
Onderzoeksproduct en/of interventie
None
Publiek
PO Box 30.001
T.P. Links
University Medical Center Groningen
PO Box 30.001
Groningen 9700 RB
The Netherlands
t.p.links@int.umcg.nl
Wetenschappelijk
PO Box 30.001
T.P. Links
University Medical Center Groningen
PO Box 30.001
Groningen 9700 RB
The Netherlands
t.p.links@int.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
The subject has a histologically confirmed diagnosis of DTC.
The subject is at least 18 years old.
The subject has written informed consent
The subject is mentally competent (according to the criteria mentioned in ¡¥WGBO boek 2, bijlage 9¡¦)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
„h The subject is 75 years or older.
„h The subject will receive treatment with rhTSH before radioiodine ablation therapy.
„h The subject has a history of severe lung disease (COPD gold class III or worse).
„h The subject has a history of cerebrovascular or coronary events.
„h The subject has a history of atrial fibrillation.
„h The subject has a history of heart failure NYHA class III or worse.
„h The subject has a severe limited physical strain (NYHA class IV)
„h The subject is unable or not willing to sign informed consent.
„h The subject is pregnant
„h The subject has contra-indications for MRI, defined as severe claustrophobia, having an implantable cardioverter-defibrillator, known allergy for gadolinium, known renal dysfunction with eGFR <30, treated with haemodialysis, or body weight >200 kg.
For the secondary objective cholesterol function and balance, subjects who meets any of the following criteria will be excluded from participation in this sub-study.
„h The subject uses lipid lowering medication
„h The subjects uses laxatives
For subjects participating in the baseline measurements:
„h The subject uses thyroid hormone medication
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL7228 |
NTR-old | NTR7427 |
CCMO | NL52832.042.15 |
OMON | NL-OMON43803 |