NCT02186405

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

July 8, 2014

Last Update Submit

October 27, 2016

Conditions

Subclinical hypothyroïdism

Outcome Measures

Primary Outcomes (1)

  • KIDNEY CLEARANCE

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

    Before treatment and 6 months after treatment

Study Arms (1)

LEVOTHYROXINE

EXPERIMENTAL

administration of levothyroxine

Drug: LEVOTHYROXINE

Interventions

LEVOTHYROXINEDRUG

administration of levothyroxine

LEVOTHYROXINE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years
  • chronic kidney disease
  • subclinical hypothyroidism
  • insulin-dependent diabetes
  • dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department

Nice, 06202, France

Location

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Guillaume FAVRE, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

June 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

FR(1)