NCT03096613

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Subclinical Hypothyroidism

Interventions

Type	Name	Description
DRUG	Levothyroxine	Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.

Timeline

• Start date: 2017-04-18
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2017-03-30
• Last updated: 2018-03-29

Locations

1 site across 1 country: China