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Effect of thyroid hormone on CVD risk in elderly patients with SCH: a multicenter, open-label, randomized controlled trial

Effect of thyroid hormone on CVD risk in elderly patients with SCH: a multicenter, open-label, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092634
Enrollment
Unknown
Registered
2024-11-20
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Subclinical hypothyroidism in the elderly

Interventions

Control group:Only regular follow-up visits were received
LT4 group:Receive levothyroxine supplementation therapy, which will be adjusted to the normal range based on thyroid stimulating hormone (TSH) levels.

Sponsors

Suqian Hospital of Nanjing Drum Tower Hospital Group
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=65 years old. 2. Diagnosis is consistent with SCH. Diagnosis of SCH is based on at least 2 measurements of TSH (more than 3 months apart) above the upper limit of the TSH reference range and FT4 within the normal range. 3. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. The subject has a history of use of levothyroxine, antithyroid drugs, amiodarone or lithium preparations in the past 3 months. 2. Thyroid surgery or radioactive iodine contact in the past 12 months. 3. Heart failure. New York Heart Association (NYHA) Class IV. 4. Cognitive dysfunction. 5. Hospitalization due to major illness or elective surgery in the past 3 months. 6. History of acute coronary syndrome, including myocardial infarction or unstable angina pectoris, in the past 3 months. 7. Untreated adrenal insufficiency or adrenal dysfunction. 8. Patients with acute infection, severe liver and kidney insufficiency, and tumors. 9. Subjects participating in ongoing randomized controlled trials of therapeutic interventions (including clinical trials of investigational drugs).

Design outcomes

Primary

MeasureTime frame
Carotid intima-media thickness;Mean of maximum plaque change at the last follow-up;

Secondary

MeasureTime frame
Fatal and non-fatal cardiovascular events (acute myocardial infarction; Stroke; amputation of peripheral vascular disease; Atherosclerotic vascular disease, including acute coronary syndrome and heart failure hospitalizations.;Difference in left ventricular ejection fraction at 12 months from baseline;Performed at 1 year versus baseline Differences in cognitive function;Difference in blood pressure (systolic and diastolic) at 12 months from baseline;Differences in lipid profiles (total cholesterol, LDL cholesterol) between 12 months and baseline.;Bone mineral density differed at baseline and at the last follow-up visit at 12 months.;

Countries

China

Contacts

Public ContactSun Yu

Suqian Hospital of Nanjing Drum Tower Hospital Group

sqsunyu@126.com+86 139 5109 8611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026