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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02186405

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Subclinical hypothyroïdism	Drug: LEVOTHYROXINE	Phase 4

Detailed Description

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LEVOTHYROXINE administration of levothyroxine	Drug: LEVOTHYROXINE administration of levothyroxine

Arm

Intervention/Treatment

Experimental: LEVOTHYROXINE

administration of levothyroxine

Drug: LEVOTHYROXINE

administration of levothyroxine

Outcome Measures

Primary Outcome Measures

KIDNEY CLEARANCE [Before treatment and 6 months after treatment]
(51)Cr-EDTA clearance after 6 months of hormonal replacement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

over 18 years
chronic kidney disease
subclinical hypothyroidism

non-inclusion Criteria:

insulin-dependent diabetes
dialysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nephrology Department	Nice		France	06202

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: Guillaume FAVRE, PhD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT02186405

Other Study ID Numbers:

14-AOI-03

First Posted:

Jul 10, 2014

Last Update Posted:

Oct 28, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Hypothyroidism

Study Results

No Results Posted as of Oct 28, 2016