DyslipidemiaNCT03606824
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)
A study testing Pitavastatin and levothyroxine in people with Dyslipidemia and Subclinical hypothyroïdism, run by Shaochun.Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia, Subclinical hypothyroïdism, Statin
- What is being tested?
- Pitavastatin and levothyroxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, China National Center for Cardiovascular Diseases
Beijing, 100031
Wenyao Wang, MD, PhD, 0086-10-88396171, wwypumc@126.com
About this study
Official title: Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in Patients With Atherosclerotic Cardiovascular Diseases (ThyroHeart-Lipid Study)
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
- Being tested
- Pitavastatin and placebo, Pitavastatin and levothyroxine
- Keywords
- Thyroid Hormone Replacement, Subclinical Hypothyroidism, Dyslipidemia, ASCVD, Statin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin and placeboDrug
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.
Pitavastatin and levothyroxineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pivastatin and placebo | Placebo comparator | After randomization, patients in Pivastatin + placebo group will receive pitavastatin and placebo. Receives: 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. Receives: Drug: Pitavastatin and levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of LDL-C levels
Absolute change value of serum LDL-C levels between the baseline and 6-month assessment.
Measured: Baseline and 6-month.
Secondary outcomes (8)
Changes of non-LDL lipid levels (TC, TG, HDL-C, non-HDL-C)
Absolute change value of serum non-LDL lipid levels (including TC, TG, HDL-C, non-HDL-C) between the baseline and 6-month assessment.
Measured: Baseline and 6-month
LDL-C control rate
Percentages of patients who had LDL-C values below the treatment goal (LDL-C<1.8mmol/L) at 1-, 2-, 3- and 6-month assessment.
Measured: Baseline and 1-, 2-, 3- and 6-month assessment.
Dosage of treatment drugs (pitavastatin and levothyroxine)
The dosage of pitavastatin and levothyroxine in combination group at 6-month assessment; The dosage of pitavastatin in control group at 6-month assessment
Measured: At 6-month assessment.
Levels of thyroid hormones at 6-month assessment
Levels of thyroid hormones (thyroid-stimulating hormone, free triiodothyronine, free thyroxine, total triiodothyronine, and total thyroxine) at 6-month assessment
Measured: At 6-month assessment.
Rates of major adverse cardiac and cerebrovascular events at 6-month assessment
Rates of major adverse cardiac and cerebrovascular events (MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events) during 6 months follow-up.
Measured: During 6-month follow-up.
Levels of glutamic-pyruvic transaminase (ALT) at 1-, 2-, 3- and 6-month assessment
Safety endpoint: live injury parameters, including levels of glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST).
Measured: Baseline and 1-, 2-, 3- and 6-month assessment.
Levels of glutamic-oxaloacetic transaminase (AST) at 1-, 2-, 3- and 6-month assessment
Safety endpoint: live injury parameters, including levels of glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST).
Measured: Baseline and 1-, 2-, 3- and 6-month assessment.
Levels of serum creatine kinase (CK) at 1-, 2-, 3- and 6-month assessment
Safety endpoint: muscle injury parameter--serum creatine kinase (CK)
Measured: Baseline and 1-, 2-, 3- and 6-month assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start25 Mar 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaochun.Li
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Peking University Third Hospital, Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Beijing Friendship Hospital
- Responsible party
- Sponsor-investigator, Shaochun.Li, China National Center for Cardiovascular Diseases
- Investigators
- Yi-Da Tang, MD, Study chair, Fuwai Hospital, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606824
- Sponsor's protocol ID
- 2018-zx7
- Status last verified
- Mar 2019
- First submitted
- 11 Jul 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20615126Tzotzas 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.
PubMed 11041458Pazos 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.
PubMed 7852521Pearce 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.
PubMed 18073305Lando 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.
PubMed 18996793Willard 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.
PubMed 24217672
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in Patients With Atherosclerotic Cardiovascular Diseases (ThyroHeart-Lipid Study)
- ClinicalTrials.gov ID
- NCT03606824
- Acronym / sponsor ID
- 2018-zx7
- Conditions
- Dyslipidemia, Subclinical hypothyroïdism, Statin, ASCVD
- Keywords
- Thyroid Hormone Replacement, Subclinical Hypothyroidism, Dyslipidemia, ASCVD, Statin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Shaochun.LiOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Peking University Third Hospital, Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Beijing Friendship Hospital
- Study start
- 25 Mar 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivastatin and placebo | Placebo comparator | Drug: Pitavastatin and placeboAfter randomization, patients in Pivastatin + placebo group will receive pitavastatin and placebo. |
| Pivastatin and LT-4 | Experimental | Drug: Pitavastatin and levothyroxineAfter randomization, patients in combination group will receive pitavastatin as the lipid-lowering therapy and take levothyroxine as the thyroid hormone supplement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitavastatin and placeboThe 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. | Drug | Pivastatin and placebo |
| Pitavastatin and levothyroxineThe 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. | Drug | Pivastatin and LT-4 |
Primary outcome
Change of LDL-C levels
Time frame: Baseline and 6-month.
Absolute change value of serum LDL-C levels between the baseline and 6-month assessment.
8 secondary outcomes
Changes of non-LDL lipid levels (TC, TG, HDL-C, non-HDL-C)
Time frame: Baseline and 6-month
LDL-C control rate
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Dosage of treatment drugs (pitavastatin and levothyroxine)
Time frame: At 6-month assessment.
Levels of thyroid hormones at 6-month assessment
Time frame: At 6-month assessment.
Rates of major adverse cardiac and cerebrovascular events at 6-month assessment
Time frame: During 6-month follow-up.
Levels of glutamic-pyruvic transaminase (ALT) at 1-, 2-, 3- and 6-month assessment
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Levels of glutamic-oxaloacetic transaminase (AST) at 1-, 2-, 3- and 6-month assessment
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Levels of serum creatine kinase (CK) at 1-, 2-, 3- and 6-month assessment
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Background: PubMed 20615126Gjedde 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.
- Background: PubMed 11041458Tzotzas 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.
- Background: PubMed 7852521Pazos 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.
- Background: PubMed 18073305Pearce 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.
- Background: PubMed 18996793Lando 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.
- Background: PubMed 24217672Willard 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Da Tang, MD study chair
Fuwai Hospital, China National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pitavastatin and levothyroxine in people with Dyslipidemia and Subclinical hypothyroïdism, run by Shaochun.Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunli Shao, MD (0086-10-88396171, chunlishao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of LDL-C levels (time frame: Baseline and 6-month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606824, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.