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

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ClinicalTrials.gov Identifier: NCT02186405
Recruitment Status : Withdrawn (No patient corresponding to inclusion criteria couldn't be enrolled in the study)
First Posted : July 10, 2014
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

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.


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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. KIDNEY CLEARANCE [ Time Frame: Before treatment and 6 months after treatment ]
    (51)Cr-EDTA clearance after 6 months of hormonal replacement



Information from the National Library of Medicine

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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:

  • over 18 years
  • chronic kidney disease
  • subclinical hypothyroidism

non-inclusion Criteria:

  • insulin-dependent diabetes
  • dialysis

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): NCT02186405


Locations
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France
Nephrology Department
Nice, France, 06202
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Guillaume FAVRE, PhD Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02186405     History of Changes
Other Study ID Numbers: 14-AOI-03
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases