Central Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005184-15-GB

Enrollment

Registered

2005-04-29

Start date

2005-05-24

Completion date

Unknown

Last updated

2013-01-21

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

Conditions

Central (secondary/tertiary) hypothyroidism (subclinical)

Interventions

Trade Name: Levothyroxine Product Name: Levothyroxine Pharmaceutical Form: Capsule* INN or Proposed INN: Levothyroxine Concentration unit: µg microgram(s) Concentration type: range Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 20-70 with hypopituitarism and free thyroxine levels within the lower third of the reference range Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: thyrotoxicosis, uncontrolled cardiac arrhythmias or unstable ischaemic heart disease, treatment with amiodarone/lithium within the last 6 months, acromegaly, Cushing's disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of change in quality of life assessed by standard questionnaires (SF-36, EQ-5D);Secondary Objective: Changes in cardiovascular parameters (24hour Holter ECG, carotid intima-media thickness), body composition (assessed by total body dual x-ray absorptiometry), lipid profile, creatine kinase, quality of life assessment by AGHDA (Adult Growth Hormone Deficiency Assessment) questionnaire, and thyroid symptom score;Primary end point(s): changes in quality of life assessed by SF-36, EQ-5D	—

Measure

Time frame

Main Objective: Assessment of change in quality of life assessed by standard questionnaires (SF-36, EQ-5D);Secondary Objective: Changes in cardiovascular parameters (24hour Holter ECG, carotid intima-media thickness), body composition (assessed by total body dual x-ray absorptiometry), lipid profile, creatine kinase, quality of life assessment by AGHDA (Adult Growth Hormone Deficiency Assessment) questionnaire, and thyroid symptom score;Primary end point(s): changes in quality of life assessed by SF-36, EQ-5D

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026