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

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ClinicalTrials.gov Identifier: NCT03096613
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
The Luhe Teaching Hospital of the Capital Medical University
Tianjin Medical University Second Hospital
The First Hospital of Hebei Medical University
Henan Provincial Hospital
Information provided by (Responsible Party):
Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Subclinical Hypothyroidism Drug: Levothyroxine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levothyroxine group
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
Drug: Levothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Other Name: Euthyrox

No Intervention: Standard therapy group
The patients in this group receive standard therapy in consistent with the local clinical practice.



Primary Outcome Measures :
  1. Distance difference of Six-minute Walk Test (6MWT) between week 24 and baseline [ Time Frame: Within 6 months of patient enrolled ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096613


Contacts
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Contact: Xuan Zhang, MD 00861088396173 katiechang@163.com
Contact: Kuo Zhang, MD 008618813019602 kzhang23@126.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences, Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Wenyao Wang, MD    00861088396173    wwypumc@126.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
The Luhe Teaching Hospital of the Capital Medical University
Tianjin Medical University Second Hospital
The First Hospital of Hebei Medical University
Henan Provincial Hospital
Investigators
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Principal Investigator: Yi-Da Tang, MD, PhD Chinese Academy of Medical Sciences, Fuwai Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi-Da Tang, Professor, chief physician, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03096613     History of Changes
Other Study ID Numbers: 2016-798
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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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
Keywords provided by Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital:
heart failure
Subclinical Hypothyroidism
levothyroxine
6-minute walk test
Additional relevant MeSH terms:
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Heart Failure
Hypothyroidism
Heart Diseases
Cardiovascular Diseases
Thyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs