Cycling from hypothyroidism to hyperthyroidism during early treatment of differentiated thyroid carcinoma

Cycling from hypothyroidism to hyperthyroidism during early treatment of differentiated thyroid carcinoma - THETA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43803

Enrollment

Registered

2015-07-30

Start date

2016-10-20

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

differentiated thyroid carcinoma - cancer of the thyroid gland

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: The subject is 75 years or older. The subject received treatment with rhTSH after thyroidectomy. The subject has a history of severe lung disease (COPD gold class III or worse). The subject has a history of cerebrovascular or coronary events. The subject is pregnant The subject has a history of atrial fibrillation. The subject has a history of heart failure NYHA class III or worse. The subject has a severe limited physical strain The subject is unable or not willing to sign informed consent.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the difference in left ventricular ejection fraction, as assessed by CMR, between week 0 and week 20. Differences will be tested with a paired t-test or, Wilcoxon test in case of a non-normal distribution.	—

Secondary

Measure	Time frame
Vascular function • Coagulation o Prothrombin, fibrogen, factor VIII o Protein C, Protein S, antithrombin III o Plasminogen, tPA • Cardial parameters, measured by Cardiac magnetic resonance imaging (CMR) o Left ventricular end diastolic diameter o Right ventricular end diastolic diameter o End diastolic thickness o Right atrial end diastolic diameter o Left atrial end diastolic diameter o End diastolic volume o End systolic volume • Cardiac output, systemic vascular resistance, stroke volume, measured by pulse wave analysis of noninvasive beat-to-beat heart rate and blood pressure recordings by a Portapres ® Cardiovascular risk profile • Total cholesterol, HDL, LDL, triglycerides, Apo A1, Apo B100 • eGFR, morning urine sample (albumin, creatinin) • sex, age, smoking habits • systolic and diastolic blood pressure • Endothelial function o Carotid distensibility o Carotid pulse wave velocity (PWV) • ECG • Cardiovascular autonomic function, derived from noninvasive beat-to-beat heart rate and blood pressure recordings by a Portapres ® o Heart Rate Variability o Baroreflex Sensitivity • Cardiovascular biomarkers o NT-proBNP o Troponin o Galactin-3 Cardiorespiratory fitness • Maximal oxygen uptake (VO2max) • Maximal respiratory exchange ratio (RERmax) • Power (W) at RER >= 1 • Maximal power (Wmax) • Maximal heart rate (Hfmax) • Rate pressure product (RPP) at Wmax, by measuring blood pressure during exercise protocol. Thyroid markers • TSH, Tg Metabolic function • Body composition o BMI • SHBG • Liver function o ASAT, ALAT, gGT • Glucose o Glucose, HbA1c Mood and cognitive function • Digit Symbol Test • Digit Span Test • Profile of Mood States (POMS) • Beck Depression Inventory II (BDI-II) Quality of Life • RAND-36 • WHO-5 • EORTC THETA Cholesterol function and balance • Plasma: Absorption plasma ratios of plant sterols to cholesterol, lathosterol/cholesterol ratio,as marker fof cholersterol synthesis, biomarker	—

Measure

Time frame

Vascular function • Coagulation o Prothrombin, fibrogen, factor VIII o Protein C, Protein S, antithrombin III o Plasminogen, tPA • Cardial parameters, measured by Cardiac magnetic resonance imaging (CMR) o Left ventricular end diastolic diameter o Right ventricular end diastolic diameter o End diastolic thickness o Right atrial end diastolic diameter o Left atrial end diastolic diameter o End diastolic volume o End systolic volume • Cardiac output, systemic vascular resistance, stroke volume, measured by pulse wave analysis of noninvasive beat-to-beat heart rate and blood pressure recordings by a Portapres ® Cardiovascular risk profile • Total cholesterol, HDL, LDL, triglycerides, Apo A1, Apo B100 • eGFR, morning urine sample (albumin, creatinin) • sex, age, smoking habits • systolic and diastolic blood pressure • Endothelial function o Carotid distensibility o Carotid pulse wave velocity (PWV) • ECG • Cardiovascular autonomic function, derived from noninvasive beat-to-beat heart rate and blood pressure recordings by a Portapres ® o Heart Rate Variability o Baroreflex Sensitivity • Cardiovascular biomarkers o NT-proBNP o Troponin o Galactin-3 Cardiorespiratory fitness • Maximal oxygen uptake (VO2max) • Maximal respiratory exchange ratio (RERmax) • Power (W) at RER >= 1 • Maximal power (Wmax) • Maximal heart rate (Hfmax) • Rate pressure product (RPP) at Wmax, by measuring blood pressure during exercise protocol. Thyroid markers • TSH, Tg Metabolic function • Body composition o BMI • SHBG • Liver function o ASAT, ALAT, gGT • Glucose o Glucose, HbA1c Mood and cognitive function • Digit Symbol Test • Digit Span Test • Profile of Mood States (POMS) • Beck Depression Inventory II (BDI-II) Quality of Life • RAND-36 • WHO-5 • EORTC THETA Cholesterol function and balance • Plasma: Absorption plasma ratios of plant sterols to cholesterol, lathosterol/cholesterol ratio,as marker fof cholersterol synthesis, biomarker

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Countries

Netherlands

Outcome results