Cardiovascular Response to Orthostatic Fractional Gravity

Healthy Volunteers Clinical Trial

— ORB  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02508818
• Other study ID #: 11-010
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2015
• Last updated: July 23, 2015
• Start date: June 2011

Study information

• Verified date: July 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

There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research).

Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers (men or women)

• Aged from 18 to 55

• Affiliated to a Social Security System

• Who accepted to take part in the study

• Who have given their written stated consent

• Who already participated in parabolic flights or performed a centrifuge run up to 4 G with head movements without occurrence of serious nausea or vomiting or cardiovascular discomfort.

• Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

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

• Pregnant women

• Medication with beta blockers, ACE inhibitors, calcium channel blockers or diuretics.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Parabolic flight

• Cardiovascular 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	systolic finger blood pressure		baseline	No
Primary	Heart rate		baseline	No