Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

Healthy Clinical Trial

— AUTOCARD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517177
• Other study ID #: 11-008
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: August 5, 2015
• Start date: June 2011

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.

Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy male volunteer

• aged from 20 to 35

• affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)

• who accepts to take part in the study

• who has given their written stated consent

• who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude .There will be no additional test

Exclusion Criteria:

• persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,

• persons who take any medication or drugs influencing the autonomic cardiovascular control

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Parabolic flight

• Cardiovascular parameters measurements

Locations

Country	Name	City	State
France	Umr Ucbn/Inserm U1075 Comete	Caen CEDEX	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The heart rate (HR) and the heart rate variability (HRV) derived from the ECG		baseline	No
Primary	The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)		baseline	No
Primary	The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV.		baseline	No
Primary	the blood pressure variability (BPV) derived from the continuous blood pressure recording		baseline	No