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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02186405

Enrollment

Registered

2014-07-10

Start date

2015-10-31

Completion date

2017-06-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclinical hypothyroïdism

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.

Interventions

DRUGLEVOTHYROXINE

administration of levothyroxine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* over 18 years * chronic kidney disease * subclinical hypothyroidism non-inclusion Criteria: * insulin-dependent diabetes * dialysis

Design outcomes

Primary

Measure	Time frame	Description
KIDNEY CLEARANCE	Before treatment and 6 months after treatment	(51)Cr-EDTA clearance after 6 months of hormonal replacement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026