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

Primary Purpose

Subclinical hypothyroïdism

Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
LEVOTHYROXINE
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subclinical hypothyroïdism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years
  • chronic kidney disease
  • subclinical hypothyroidism

non-inclusion Criteria:

  • insulin-dependent diabetes
  • dialysis

Sites / Locations

  • Nephrology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LEVOTHYROXINE

Arm Description

administration of levothyroxine

Outcomes

Primary Outcome Measures

KIDNEY CLEARANCE
(51)Cr-EDTA clearance after 6 months of hormonal replacement

Secondary Outcome Measures

Full Information

First Posted
July 8, 2014
Last Updated
October 27, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02186405
Brief Title
Effects of Levothyroxine Treatment on Hemodynamic and Renal Functions in Subclinical Hypothyroidism
Official Title
Effects of Levothyroxine Treatment on Hemodynamic and Isotopic Renal Functions in Subclinical Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No patient corresponding to inclusion criteria couldn't be enrolled in the study
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. 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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical hypothyroïdism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEVOTHYROXINE
Arm Type
Experimental
Arm Description
administration of levothyroxine
Intervention Type
Drug
Intervention Name(s)
LEVOTHYROXINE
Intervention Description
administration of levothyroxine
Primary Outcome Measure Information:
Title
KIDNEY CLEARANCE
Description
(51)Cr-EDTA clearance after 6 months of hormonal replacement
Time Frame
Before treatment and 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years chronic kidney disease subclinical hypothyroidism non-inclusion Criteria: insulin-dependent diabetes dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume FAVRE, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Department
City
Nice
ZIP/Postal Code
06202
Country
France

12. IPD Sharing Statement

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

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