Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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

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Heart Failure Subclinical Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levothyroxine group

The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.

Standard therapy group

The patients in this group receive standard therapy in consistent with the local clinical practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levothyroxine

Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.

Intervention Type DRUG

Other Intervention Names

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Euthyrox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No