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

Information source: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Subclinical hypothyroïdism

Intervention: LEVOTHYROXINE (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Centre Hospitalier Universitaire de Nice

Overall contact:
Marine LOCHOUARN, Email: lochouarn.m@chu-nice.fr

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. 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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: KIDNEY CLEARANCE

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. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- over 18 years

- chronic kidney disease

- subclinical hypothyroidism

non-inclusion Criteria:

- insulin-dependent diabetes

- dialysis

Locations and Contacts

Marine LOCHOUARN, Email: lochouarn.m@chu-nice.fr

Nephrology Department, Nice 06202, France; Not yet recruiting
marine LOCHOUARN, Email: lochouarn.m@chu-nice.fr
Guillaume FAVRE, PhD, Principal Investigator
Additional Information

Starting date: December 2014
Last updated: November 4, 2014

Page last updated: August 23, 2015

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