STUDY TO EVALUATE THE EFFICACY OF LEVOTHYROXINE AND LIOTIRONINE IN POST-SURGICAL HYPOTHYROIDISM PATIENTS: EFFECTS ON METABOLIC AND CARDIAC PARAMETERS AND QUALITY OF LIFE

Phase 1

• Conditions: POST-SURGICAL HYPOTHYROIDISM; MedDRA version: 20.0Level: LLTClassification code 10036429Term: Postsurgical hypothyroidismSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-001261-25-IT
• Lead Sponsor: AOU FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

- Age between 18 and 50 years
- Patients with diagnosis of post-surgical hypothyroidism after total thyroidectomy for nodular goiter or differentiated thyroid cancer
- Patients in therapy with LT4 with biochemical euthyroidism (TSH 1.5 -2,5 mIU/L)
- Patients able to give informed consent

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 86
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with metastatic differentiated thyroid carcinoma
- Post surgical hypoparathyroidism
- Current major medical disorders (renal, hepatic, neurologic or psychiatric diseases, diabetes mellitus)
- Cardiovascular disease (arterial hypertension, atrial or ventricular arrhythmias, shortened P-R interval, coronary heart disease, heart failure)
-Gastrointestinal disease: malabsorption syndromes (celiac disease, lactose intolerance) and gastric diseases (gastroesophageal reflux disease, autoimmune gastritis, Helicobacter pylori gastritis)
- Administration of drugs interfering with LT4 absorption, drugs that increase gastric PH (antacids such as proton pump inhibitors and H2 receptor antagonists...) or may have an altered clearance of LT4 or deiodinase activity
- Pregnancy
- Age < 18 and age >50 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.;Secondary Objective: Evaluation of the efficacy and risk/ benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life<br>- Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning)<br>;Primary end point(s): To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of the efficacy and risk / benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life - Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning);Timepoint(s) of evaluation of this end point: 12 months