Heart Failure, Subclinical Hypothyroidism
Conditions
Keywords
heart failure, Subclinical Hypothyroidism, levothyroxine, 6-minute walk test
Brief 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. 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.
Interventions
DRUGLevothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Sponsors
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
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline | Within 6 months of patient enrolled |
Secondary
| Measure | Time frame |
|---|---|
| Change in NYHA classification between week 24 and baseline. | Within 6 months of patient enrolled |
| Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment | Within 6 months of patient enrolled |
| Composite of cardiovascular death, re-hospitalization for cardiovascular disease, severe arrhythmia, and stroke during the 24 weeks treatment | Within 6 months of patient enrolled |
| Difference of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level between week 24 and baseline | Within 6 months of patient enrolled |
| Difference of MLHFQ between week 24 and baseline | Within 6 months of patient enrolled |
| Difference of serum lipid profiles between week 24 and baseline | Within 6 months of patient enrolled |
| Adverse events | Within 6 months of patient enrolled |
| Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline | Within 6 months of patient enrolled |
Countries
China
Contacts
Primary ContactXuan Zhang, MD
Backup ContactKuo Zhang, MD
Outcome results
None listed