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Status unknownNCT03096613Updated Mar 29, 2018

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

A Phase 4 interventional study of Levothyroxine in Heart Failure and Subclinical Hypothyroidism, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Subclinical Hypothyroidism

Keywords

  • heart failure
  • Subclinical Hypothyroidism
  • levothyroxine
  • 6-minute walk test
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 124 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Levothyroxine group

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

    Drug: Levothyroxine

  • No intervention
    Standard therapy group

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

Interventions

  • DrugLevothyroxine

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

    Also known as: Euthyrox

06

What researchers measure

Primary outcomes

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

    Time frame: Within 6 months of patient enrolled

Secondary outcomes

  1. 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

  2. Change in NYHA classification between week 24 and baseline.

    Time frame: Within 6 months of patient enrolled

  3. Composite of cardiovascular death or heart failure re-hospitalization during the 24 weeks treatment

    Time frame: Within 6 months of patient enrolled

  4. 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

  5. Difference of echocardiographic and cardiac magnetic resonance imaging measures between week 24 and baseline

    Time frame: Within 6 months of patient enrolled

  6. Difference of MLHFQ between week 24 and baseline

    Time frame: Within 6 months of patient enrolled

  7. Difference of serum lipid profiles between week 24 and baseline

    Time frame: Within 6 months of patient enrolled

  8. Adverse events

    Time frame: Within 6 months of patient enrolled

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences, Fuwai Hospital
    Beijing, Beijing 100037, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 30782213 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03096613
Lead 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
Responsible party
Yi-Da Tang (Professor, chief physician, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Mar 30, 2017
Start date
Apr 18, 2017
Primary completion
Feb 2019 (estimated)
Completion
Feb 2019 (estimated)
Last update
Mar 29, 2018

Study contacts

Xuan Zhang, MD
Contact
katiechang@163.com
00861088396173
Kuo Zhang, MD
Contact
kzhang23@126.com
008618813019602
Yi-Da Tang, MD, PhD
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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