NCT03096613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

March 25, 2017

Last Update Submit

March 28, 2018

Conditions

Heart FailureSubclinical Hypothyroidism

Keywords

heart failureSubclinical Hypothyroidismlevothyroxine6-minute walk test

Outcome Measures

Primary Outcomes (1)

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

    Within 6 months of patient enrolled

Secondary Outcomes (8)

  • 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

  • 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 echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline

    Within 6 months of patient enrolled

  • +3 more secondary outcomes

Study Arms (2)

Levothyroxine group

EXPERIMENTAL

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

Drug: Levothyroxine

Standard therapy group

NO INTERVENTION

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

Interventions

LevothyroxineDRUG

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

Also known as: Euthyrox
Levothyroxine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (2)

  • Wang W, Zhang X, Gao J, Meng X, Wang J, Zhang K, Chen J, Qi J, Shao C, Tang YD. Effects of levothyroxine in subclinical hypothyroidism and heart failure with reduced ejection fraction: An open-label randomized trial. Cell Rep Med. 2024 Apr 16;5(4):101473. doi: 10.1016/j.xcrm.2024.101473. Epub 2024 Mar 26.

    PMID: 38537636DERIVED

  • 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.

    PMID: 30782213DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Yi-Da Tang, MD, PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Zhang, MD

CONTACT

00861088396173katiechang@163.com

Kuo Zhang, MD

CONTACT

008618813019602kzhang23@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, chief physician

Study Record Dates

First Submitted

March 25, 2017

First Posted

March 30, 2017

Study Start

April 18, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

CN(1)