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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096613
• Other study ID #: 2016-798
• Status: Recruiting
• Phase: Phase 4
• First received: March 25, 2017
• Last updated: March 28, 2018
• Start date: April 18, 2017
• Est. completion date: February 2019

Study information

• Verified date: March 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xuan Zhang, MD
• Phone: 00861088396173
• Email: katiechang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Hypothyroidism
• Subclinical Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Henan Provincial Hospital, The First Hospital of Hebei Medical University, The Luhe Teaching Hospital of the Capital Medical University, Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline		Within 6 months of patient enrolled
Secondary	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
Secondary	Change in NYHA classification between week 24 and baseline.		Within 6 months of patient enrolled
Secondary	Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment		Within 6 months of patient enrolled
Secondary	Composite of cardiovascular death, re-hospitalization for cardiovascular disease, severe arrhythmia, and stroke during the 24 weeks treatment		Within 6 months of patient enrolled
Secondary	Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline		Within 6 months of patient enrolled
Secondary	Difference of MLHFQ between week 24 and baseline		Within 6 months of patient enrolled
Secondary	Difference of serum lipid profiles between week 24 and baseline		Within 6 months of patient enrolled
Secondary	Adverse events		Within 6 months of patient enrolled