NCT02685371

Brief Summary

This study will evaluate the effect of deep breathing manoeuvres on inter ventricular interdependency physiology. By providing further insight in this basic physiology we want to add more comprehensive data in favor or not of constrictive pericarditis diagnostic criteria currently used in cardiovascular magnetic resonance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

3.4 years

First QC Date

January 13, 2016

Last Update Submit

September 1, 2018

Conditions

Constrictive Pericarditis

Outcome Measures

Primary Outcomes (1)

  • Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.

    Analysis of respiratory-related septal excursion. The relative position of the septum can be obtained by dividing the distance between RV free wall and septum by the biventricular distance. If done during inspiration and expiration, at early ventricular filling, the respiratory-related septal excursion can be quantified.

    Immediate

Secondary Outcomes (6)

  • Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.

    Immediate

  • Measurement of the variation of flow through the mitral and tricuspid valve between inspiration and expiration as assessed by CMR.

    Immediate

  • Biventricular Index: measurement of the heart contour between inspiration and expiration as assessed by CMR.

    Immediate

  • Presence or absence (categorical variable) of diastolic flow reversal in inferior vein cave as assessed by cardiovascular magnetic resonance (CMR).

    Immediate

  • Presence or Absence of lack of myocardial slippage in relation to the pericardium as assessed by CMR (tagging sequence)

    Immediate

  • +1 more secondary outcomes

Study Arms (1)

Breathing effort type

Current known criteria for constrictive pericarditis will be test under: 1- spontaneous breathing 2- Breathing with a negative pressure of -15 to - 30 cm of water 3- Breathing with a negative pressure of more than - 30 cm of water.

Behavioral: Breathing

Interventions

BreathingBEHAVIORAL

Subjects will have to breath 1- Spontaneously 2- to produce a negative pressure of -15 to -30 cm of water and 3- to produce a negative pressure more than -30 cm of water.

Breathing effort type

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population consists of healthy subjects not know for any cardiovascular disease.

You may qualify if:

  • Men and women between 18 and 80 years old
  • Normal transthoracic echocardiogram if older than 41 years old
  • Normal standardized history and physical examination
  • Normal blood pressure (\<130/80)
  • Normal 12-lead ECG at rest.

You may not qualify if:

  • No prior pulmonary or cardiac diseases
  • Unexplained symptoms that could be related to a heart or pulmonary problems.
  • Symptoms of or active cardiovascular or pulmonary problems
  • Hepatic or kidney dysfunction
  • Blood cell dyscrasia
  • Cardiovascular risk factor (smoking, hypertension, dyslipidemia, diabetes)
  • Obesity (BMI \> 30)
  • Pregnancy or pregnancy in the last year
  • Cardiac congenital anomalies discovered during the cardiovascular magnetic resonance
  • Current medication with cardiovascular side effects known (diuretics, beta-blockers, calcium channel blockers)
  • Contraindication to cardiovascular magnetic resonance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paul

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Pericarditis, Constrictive

Interventions

Respiration

Condition Hierarchy (Ancestors)

PericarditisHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Farand Paul, M.D.

CONTACT

819-346-1110paul.farand@usherbrooke.ca

Etienne L Couture, M.D.

CONTACT

819-346-1110etienne.couture@usherbrooke.ca

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 13, 2016

First Posted

February 18, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

CA(1)