NCT03436030

Brief Summary

Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

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

November 18, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

April 22, 2019

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

December 15, 2017

Last Update Submit

April 19, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver

    Echocardiographic measure, comparing control measurement to measurement during breathing manoeuver

    30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence

Study Arms (1)

Single arm, breathing manuevers

EXPERIMENTAL

All subjects perform/undergo Valsalva, Muller, CPAP, hand grip, and passive leg raise, with ultrasound examination of heart recorded before and during the manoeuvre.

Other: Simple breathing manuevers during brief echocardiographic imaging

Interventions

Simple breathing manuevers during brief echocardiographic imagingOTHER

Valsalva, Muller, light mask CPAP, leg raising, hand grip.

Single arm, breathing manuevers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults

You may not qualify if:

  • known heart or lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University, and the University Hospital of Umeå

Umeå, 90185, Sweden

Location

Related Publications (1)

  • Gottfridsson P, A'Roch R, Lindqvist P, Law L, Myrberg T, Hultin M, A'Roch A, Haney M. Left atrial contraction strain and controlled preload alterations, a study in healthy individuals. Cardiovasc Ultrasound. 2022 Mar 30;20(1):8. doi: 10.1186/s12947-022-00278-1.

    PMID: 35354482DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

February 19, 2018

Study Start

November 18, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 22, 2019

Record last verified: 2018-02

Locations

SE(1)