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

Primary Purpose

Heart Failure, Subclinical Hypothyroidism

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Levothyroxine
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, Subclinical Hypothyroidism, levothyroxine, 6-minute walk test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical Sciences, Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Levothyroxine group

Standard therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline

Secondary Outcome Measures

Difference of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level between week 24 and baseline
Change in NYHA classification between week 24 and baseline.
Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment
Composite of cardiovascular death, re-hospitalization for cardiovascular disease, severe arrhythmia, and stroke during the 24 weeks treatment
Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline
Difference of MLHFQ between week 24 and baseline
Difference of serum lipid profiles between week 24 and baseline
Adverse events

Full Information

First Posted
March 25, 2017
Last Updated
March 28, 2018
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT03096613
Brief Title
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Subclinical Hypothyroidism
Keywords
heart failure, Subclinical Hypothyroidism, levothyroxine, 6-minute walk test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levothyroxine group
Arm Type
Experimental
Arm Description
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
Arm Title
Standard therapy group
Arm Type
No Intervention
Arm Description
The patients in this group receive standard therapy in consistent with the local clinical practice.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Euthyrox
Intervention Description
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Primary Outcome Measure Information:
Title
Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline
Time Frame
Within 6 months of patient enrolled
Secondary Outcome Measure Information:
Title
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
Title
Change in NYHA classification between week 24 and baseline.
Time Frame
Within 6 months of patient enrolled
Title
Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment
Time Frame
Within 6 months of patient enrolled
Title
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
Title
Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline
Time Frame
Within 6 months of patient enrolled
Title
Difference of MLHFQ between week 24 and baseline
Time Frame
Within 6 months of patient enrolled
Title
Difference of serum lipid profiles between week 24 and baseline
Time Frame
Within 6 months of patient enrolled
Title
Adverse events
Time Frame
Within 6 months of patient enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Zhang, MD
Phone
00861088396173
Email
katiechang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo Zhang, MD
Phone
008618813019602
Email
kzhang23@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Da Tang, MD, PhD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences, Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyao Wang, MD
Phone
00861088396173
Email
wwypumc@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30782213
Citation
Zhang 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.
Results Reference
derived

Learn more about this trial

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

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