Heart FailurePhase 4NCT03096613
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)
A Phase 4 study testing Levothyroxine in people with Heart Failure and Subclinical Hypothyroidism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (HF) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with HF and subclinical hypothyroidism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Subclinical Hypothyroidism
- What is being tested?
- Levothyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2017to Feb 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, male or female.
- Systolic heart failure with New York Heart Association (NYHA) class II-III.
- Left ventricular ejection fraction (LVEF) less than 40% by echocardiography during screening and randomization.
- SCH (TSH: upper limits of normal (ULN) -10mIU/L, and FT4 level within reference range).
- Having received standard HF therapy for at least 2 weeks, having reached target dose or max tolerable dose.
- Provided informed consent.
Who cannot join
- Acute heart failure or acute exacerbation of chronic heart failure within the past 2 weeks.
- Scheduled cardiac resynchronization therapy or heart transplantation.
- History of malignant tumor or life expectancy under 12 months.
- Already on medications that may affect thyroid function (L-T4, carbimazole, propylthiouracil, amiodarone, lithium).
- Pregnancy and lactation period.
- Participation in another clinical trial within the past 30 days.
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- Contraindication or intolerance to evidence-based therapy for CHF, such as beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.
- Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s).
- Untreated adrenal insufficiency.
- Untreated pituitary insufficiency.
- Untreated thyrotoxicosis.
- Treatment with levothyroxine must not be initiated in patients with acute myocardial infarction, acute myocarditis, or acute pancarditis.
- Severe renal dysfunction (eGFR≤30 ml/min/1.73m2).
- Significant hepatic impairment (Serum GPT > 120 U/L).
- Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Wenyao Wang, MD, 00861088396173, wwypumc@126.com
About this study
Official title: Efficacy and Safety of Levothyroxine (L-T4) Replacement on Exercise Capability in Chronic Systolic Heart Failure Patients With Subclinical Hypothyroidism: A 24-week, Multi-center, Open Label, Randomized, Parallel Group Trial
Based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (HF) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with HF and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard therapy in stable chronic heart failure patients with subclinical hypothyroidism.
Read the detailed description
The primary objective of this trial is to determine whether the 24-week L-T4 replacement therapy, as an adjunct to standard treatment, would improve exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism compared to the standard treatment.
- Conditions
- Heart Failure, Subclinical Hypothyroidism
- Being tested
- Levothyroxine
- Keywords
- heart failure, Subclinical Hypothyroidism, levothyroxine, 6-minute walk test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Euthyrox
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine group | Experimental | The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug. Receives: Drug: Levothyroxine |
| Standard therapy group | No intervention | The patients in this group receive standard therapy in consistent with the local clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline
Measured: Within 6 months of patient enrolled
Secondary outcomes (8)
Difference of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level between week 24 and baseline
Measured: Within 6 months of patient enrolled
Change in NYHA classification between week 24 and baseline.
Measured: Within 6 months of patient enrolled
Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment
Measured: Within 6 months of patient enrolled
Composite of cardiovascular death, re-hospitalization for cardiovascular disease, severe arrhythmia, and stroke during the 24 weeks treatment
Measured: Within 6 months of patient enrolled
Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline
Measured: Within 6 months of patient enrolled
Difference of MLHFQ between week 24 and baseline
Measured: Within 6 months of patient enrolled
Difference of serum lipid profiles between week 24 and baseline
Measured: Within 6 months of patient enrolled
Adverse events
Measured: Within 6 months of patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start18 Apr 2017
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University, Tianjin Medical University Second Hospital, The First Hospital of Hebei Medical University, Henan Provincial People's Hospital
- Responsible party
- Principal investigator, Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yi-Da Tang, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096613
- Sponsor's protocol ID
- 2016-798
- Status last verified
- Mar 2018
- First submitted
- 25 Mar 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang W, Zhang X, Gao J, Meng X, Wang J, Zhang K, Chen J, Qi J, Shao C, Tang YD. Effects of levothyroxine in subclinical hypothyroidism and heart failure with reduced ejection fraction: An open-label randomized trial. Cell Rep Med. 2024 Apr 16;5(4):101473. doi: 10.1016/j.xcrm.2024.101473. Epub 2024 Mar 26.
PubMed 38537636Zhang X, Wang WY, Zhang K, Tian J, Zheng JL, Chen J, An SM, Wang SY, Liu YP, Zhao Y, Wang JJ, Yang M, Tang YD. Efficacy and safety of levothyroxine (L-T4) replacement on the exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism: Study protocol for a multi-center, open label, randomized, parallel group trial (ThyroHeart-CHF). Trials. 2019 Feb 19;20(1):143. doi: 10.1186/s13063-019-3219-5.
PubMed 30782213
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Levothyroxine (L-T4) Replacement on Exercise Capability in Chronic Systolic Heart Failure Patients With Subclinical Hypothyroidism: A 24-week, Multi-center, Open Label, Randomized, Parallel Group Trial
- ClinicalTrials.gov ID
- NCT03096613
- Acronym / sponsor ID
- 2016-798
- Conditions
- Heart Failure, Subclinical Hypothyroidism
- Keywords
- heart failure, Subclinical Hypothyroidism, levothyroxine, 6-minute walk test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University, Tianjin Medical University Second Hospital, The First Hospital of Hebei Medical University, Henan Provincial People's Hospital
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 30 Mar 2017 (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.
Based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (HF) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with HF and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard therapy in stable chronic heart failure patients with subclinical hypothyroidism.
Detailed description
The primary objective of this trial is to determine whether the 24-week L-T4 replacement therapy, as an adjunct to standard treatment, would improve exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism compared to the standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine group | Experimental | Drug: LevothyroxineThe patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug. |
| Standard therapy group | No intervention | –The patients in this group receive standard therapy in consistent with the local clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older, male or female.
- Systolic heart failure with New York Heart Association (NYHA) class II-III.
- Left ventricular ejection fraction (LVEF) less than 40% by echocardiography during screening and randomization.
- SCH (TSH: upper limits of normal (ULN) -10mIU/L, and FT4 level within reference range).
- Having received standard HF therapy for at least 2 weeks, having reached target dose or max tolerable dose.
Key exclusion criteria (15 listed)
- Acute heart failure or acute exacerbation of chronic heart failure within the past 2 weeks.
- Scheduled cardiac resynchronization therapy or heart transplantation.
- History of malignant tumor or life expectancy under 12 months.
- Already on medications that may affect thyroid function (L-T4, carbimazole, propylthiouracil, amiodarone, lithium).
- Pregnancy and lactation period.
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 |
|---|---|---|
| LevothyroxineAlso: EuthyroxLevothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine. | Drug | Levothyroxine group |
Primary outcome
Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline
Time frame: Within 6 months of patient enrolled
8 secondary outcomes
Difference of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level between week 24 and baseline
Time frame: Within 6 months of patient enrolled
Change in NYHA classification between week 24 and baseline.
Time frame: Within 6 months of patient enrolled
Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment
Time frame: Within 6 months of patient enrolled
Composite of cardiovascular death, re-hospitalization for cardiovascular disease, severe arrhythmia, and stroke during the 24 weeks treatment
Time frame: Within 6 months of patient enrolled
Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline
Time frame: Within 6 months of patient enrolled
Difference of MLHFQ between week 24 and baseline
Time frame: Within 6 months of patient enrolled
Difference of serum lipid profiles between week 24 and baseline
Time frame: Within 6 months of patient enrolled
Adverse events
Time frame: Within 6 months of patient enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 38537636Wang W, Zhang X, Gao J, Meng X, Wang J, Zhang K, Chen J, Qi J, Shao C, Tang YD. Effects of levothyroxine in subclinical hypothyroidism and heart failure with reduced ejection fraction: An open-label randomized trial. Cell Rep Med. 2024 Apr 16;5(4):101473. doi: 10.1016/j.xcrm.2024.101473. Epub 2024 Mar 26.
- Derived from this study: PubMed 30782213Zhang X, Wang WY, Zhang K, Tian J, Zheng JL, Chen J, An SM, Wang SY, Liu YP, Zhao Y, Wang JJ, Yang M, Tang YD. Efficacy and safety of levothyroxine (L-T4) replacement on the exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism: Study protocol for a multi-center, open label, randomized, parallel group trial (ThyroHeart-CHF). Trials. 2019 Feb 19;20(1):143. doi: 10.1186/s13063-019-3219-5.
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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, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine in people with Heart Failure and Subclinical Hypothyroidism, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 6 inclusion and 15 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 29 Mar 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xuan Zhang, MD (00861088396173, katiechang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline (time frame: Within 6 months of patient enrolled). 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 NCT03096613, which also lists 2 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 29 Mar 2018.