Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypothyroidism; Myocardial Infarction

Treatments: Drug: Levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02512978

Z15110700400000

Details and patient eligibility

About

Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

Full description

The primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for AMI is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 - 75, male or non-pregnant female;
2. Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);
3. With presence of hypothyroid status (i.e., TSH >7.0 mIU/L and (or) fT3 <1.79 pg/mL);
4. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion criteria

1. Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;
2. Symptoms of severe heart failure (Killip Class III and above);
3. Severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
4. Impaired liver function before surgery: Serum GPT > 120U/L;
5. Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;
6. Those taking medicine which can affect the test of thyroid function;
7. Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;
8. Those having prior myocardial infarction;
9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Levothyroxine group

Experimental group

Description:

The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.

Treatment:

Drug: Levothyroxine

Standard therapy group

No Intervention group

Description:

The patients in this group receive standard therapy in consistent with the local clinical practice.