Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)

NCT03606824 | Unknown

• 1 other identifier: 2018-zx7
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

In ASCVD patients complicated with subclinical hypothyroidism, the percentage of those who did not reach the target of lipid-lowering therapy (LDL-C\>1.8mmol/L) is usually higher than that in population with normal thyroid function. The present study aims to randomly compare two lipid-lowering therapeutic strategies (statins only vs. statins combined with thyroid hormone supplement).

Conditions

Dyslipidemia; Subclinical hypothyroïdism; Statin; ASCVD

Keywords

Thyroid Hormone Replacement; Subclinical Hypothyroidism; Dyslipidemia; ASCVD; Statin

Outcome Measures

Primary Outcomes (1)

• Change of LDL-C levels

  Absolute change value of serum LDL-C levels between the baseline and 6-month assessment.

  Baseline and 6-month.

Secondary Outcomes (8)

• Changes of non-LDL lipid levels (TC, TG, HDL-C, non-HDL-C)

  Baseline and 6-month

• LDL-C control rate

  Baseline and 1-, 2-, 3- and 6-month assessment.

• Dosage of treatment drugs (pitavastatin and levothyroxine)

  At 6-month assessment.

• Levels of thyroid hormones at 6-month assessment

  At 6-month assessment.

• Rates of major adverse cardiac and cerebrovascular events at 6-month assessment

  During 6-month follow-up.

Study Arms (2)

Pivastatin and placebo

PLACEBO COMPARATOR

After randomization, patients in Pivastatin + placebo group will receive pitavastatin and placebo.

Drug: Pitavastatin and placebo

Pivastatin and LT-4

EXPERIMENTAL

After randomization, patients in combination group will receive pitavastatin as the lipid-lowering therapy and take levothyroxine as the thyroid hormone supplement.

Drug: Pitavastatin and levothyroxine

Interventions

Pitavastatin and placebo DRUG

The initial dosage of pitavastatin is 2mg, and it will be regulated according to the level of LDL-C and the upper limit is 4mg.Since the investigators are blind to the arms,the fake regulation of placebo dosage will be same as the Pitavastatin and levothyroxine group.

Pivastatin and placebo

Pitavastatin and levothyroxine DRUG

The initial dosage of pitavastatin is 2mg and the initial dosage of levothyroxine is 12.5ug. The dosage of levothyroxine will be regulated according to thyroid function test every 2-3 weeks. The regulation of pitavastatin dosage is same as the monotherapy group.

Pivastatin and LT-4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female;
• Stable or unstable angina with evidence of myocardial ischemia; coronary angiography reveals stenosis lesions;
• Subclinical hypothyroidism defined as mild TSH elevation within 5-10mIU/L and normal serum thyroid hormone levels within reference ranges;
• Level of LDL-C is more than 1.8mmol/L before randomization.
• Participate in the trial voluntarily and signs the written informed consent form.

You may not qualify if:

• Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
• Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventricle ngiography);
• Pregnant or lactating women;
• Complicated with severe organ dysfunction: large number of pericardial effusion; acute myocardial infarction; acute myocarditis; acute left heart failure; cardiogenic shock; severe arrhythmia, such as ventricular tachycardia, ventricular fibrillation, frequent atrial / ventricular premature beat, poor control of fast ventricular fibrillation, and bradycardia requiring pacemaker therapy, etc.
• Patients who are unable to withstand lipid-lowering therapy or thyroid hormone replacement due to allergy to statins or levothyroxine;
• Serum AST/ALT is three times higher than the upper limits of normal.
• Patient's life expectancy is less than 12 months;
• Those waiting for heart transplantation;
• Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Sponsors & Collaborators

• Shaochun.Li: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Peking University Third Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Fuwai Hospital, China National Center for Cardiovascular Diseases

Beijing, 100031, China

RECRUITING

Related Publications (6)

• Gjedde S, Gormsen LC, Rungby J, Nielsen S, Jorgensen JO, Pedersen SB, Riis AL, Weeke J, Moller N. Decreased lipid intermediate levels and lipid oxidation rates despite normal lipolysis in patients with hypothyroidism. Thyroid. 2010 Aug;20(8):843-9. doi: 10.1089/thy.2009.0212.

  PMID: 20615126 BACKGROUND

• Tzotzas T, Krassas GE, Konstantinidis T, Bougoulia M. Changes in lipoprotein(a) levels in overt and subclinical hypothyroidism before and during treatment. Thyroid. 2000 Sep;10(9):803-8. doi: 10.1089/thy.2000.10.803.

  PMID: 11041458 BACKGROUND

• Pazos F, Alvarez JJ, Rubies-Prat J, Varela C, Lasuncion MA. Long-term thyroid replacement therapy and levels of lipoprotein(a) and other lipoproteins. J Clin Endocrinol Metab. 1995 Feb;80(2):562-6. doi: 10.1210/jcem.80.2.7852521.

  PMID: 7852521 BACKGROUND

• Pearce EN, Wilson PW, Yang Q, Vasan RS, Braverman LE. Thyroid function and lipid subparticle sizes in patients with short-term hypothyroidism and a population-based cohort. J Clin Endocrinol Metab. 2008 Mar;93(3):888-94. doi: 10.1210/jc.2007-1987. Epub 2007 Dec 11.

  PMID: 18073305 BACKGROUND

• Lando HM, Burman KD. Two cases of statin-induced myopathy caused by induced hypothyroidism. Endocr Pract. 2008 Sep;14(6):726-31. doi: 10.4158/EP.14.6.726.

  PMID: 18996793 BACKGROUND

• Willard DL, Leung AM, Pearce EN. Thyroid function testing in patients with newly diagnosed hyperlipidemia. JAMA Intern Med. 2014 Feb 1;174(2):287-9. doi: 10.1001/jamainternmed.2013.12188. No abstract available.

  PMID: 24217672 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Interventions

pitavastatin; Thyroxine

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yi-Da Tang, MD

  Fuwai Hospital, China National Center for Cardiovascular Diseases

  STUDY CHAIR

Central Study Contacts

Chunli Shao, MD

CONTACT

0086-10-88396171; chunlishao@126.com

Wenyao Wang, MD, PhD

CONTACT

0086-10-88396173; wwypumc@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant physician

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 31, 2018
• Study Start: March 25, 2019
• Primary Completion: February 28, 2020
• Study Completion: May 31, 2020
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

CN (1)