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Effects of Levothyroxine Treatment on Hemodynamic and Renal Functions in Subclinical Hypothyroidism

NCT ID: NCT02186405

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-06-30

Brief Summary

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Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution.

Detailed Description

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Animal experimental hypothyroidism is associated with renal and hemodynamic abnormalities. In human, exact measurements of GFR showed a decline in GFR after thyroidectomy and an increase in GFR and renal blood flow after hormone replacement. Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies. A retrospective study suggests that treatment of subclinical hypothyroidism may slow the degradation rate of renal function estimated by MDRD. However, the potential hemodynamic benefit of treatment has not yet been studied.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution. This open prospective study will include 16 patients in order to detect an increase of 1.2 standard deviation for the measured glomerular filtration.

Conditions

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Subclinical hypothyroïdism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LEVOTHYROXINE

administration of levothyroxine

Group Type EXPERIMENTAL

LEVOTHYROXINE

Intervention Type DRUG

administration of levothyroxine

Interventions

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LEVOTHYROXINE

administration of levothyroxine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* over 18 years
* chronic kidney disease
* subclinical hypothyroidism


* insulin-dependent diabetes
* dialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume FAVRE, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Nephrology Department

Nice, , France

Site Status

Countries

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France

Other Identifiers

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14-AOI-03

Identifier Type: -

Identifier Source: org_study_id