Phase
Condition
Hormone Deficiencies
Female Hormonal Deficiencies/abnormalities
Congestive Heart Failure
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 duringscreening and randomization.
SCH (TSH: upper limits of normal (ULN) -10mIU/L, and FT4 level within referencerange).
Having received standard HF therapy for at least 2 weeks, having reached target doseor max tolerable dose.
Provided informed consent.
Exclusion
Exclusion Criteria:
Acute heart failure or acute exacerbation of chronic heart failure within the past 2weeks.
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 asbeta-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 myocardialinfarction, 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'ssafety or compliance with the protocol.
Study Design
Study Description
Connect with a study center
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing 100037
ChinaActive - Recruiting

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