NCT03639909

Brief Summary

Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes. CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing). First screening for CAN (as proposed in diabetic patients) can be performed by assessing heart rate (HR) response to deep breathing, blood pressure (BP) and HR response to a 5 minutes stand test

Trial Health

100
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 17, 2018

Last Update Submit

August 20, 2018

Conditions

Keywords

sweat gland

Outcome Measures

Primary Outcomes (1)

  • Sweating autonomic test

    Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD

    baseline

Study Arms (2)

MSA-P

Patients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function

Procedure: sweating functionProcedure: Cardiovascular function

PD patients

Parkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function

Procedure: sweating functionProcedure: Cardiovascular function

Interventions

Sweating dysfunction by Sudoscan

Also known as: sweating dysfunction by Sudoscan
MSA-PPD patients

Cardiovascular (CV) tests

MSA-PPD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the autonomic laboratory of the neurology department at Toulouse University Hospital

You may qualify if:

  • Patients with MSA-P or PD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nervous System Diseases

Interventions

SweatingCardiovascular Physiological Phenomena

Intervention Hierarchy (Ancestors)

Body Temperature RegulationBody TemperaturePhysiological PhenomenaHomeostasisSkin Physiological PhenomenaIntegumentary System Physiological PhenomenaAdaptation, PhysiologicalAdaptation, BiologicalBiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Anne Pavy-Le Traon, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share