NCT01727310

Brief Summary

Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic". it is characterized by discomfort LV filling may worsen and lead typically to a pressure increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction. Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. The onset of symptoms sign an intolerance to the increase in LV filling pressures and LA , causing pulmonary hypertension . Therefore, the study of the level of LV and LA filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced. Pressures filling pressures can be explored by two methods:

  • cardiac catheterization, which is a direct and invasive measurement method
  • echocardiography, which is an indirect measurement method which has the advantage of being non-invasive The goal of this research is to compare the two methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

2 active sites

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 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.5 years

First QC Date

November 12, 2012

Last Update Submit

May 24, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • quality of echocardiography

    Evaluate the diagnostic quality of echocardiography to measure the volume of the LA indexed to body surface area compared to cardiac catheterization

Eligibility Criteria

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

Patients of both gender hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization .

You may qualify if:

  • Older than 18 years;
  • Patients hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization

You may not qualify if:

  • Pregnant women
  • Patients with a history of valve replacement surgery,
  • Patients with other valvular\> grade 2 associated with the coarctation
  • Patients known to have ischemic heart disease or in whom angiography showed significant coronary artery disease;
  • Patients with chronic or paroxysmal atrial fibrillation
  • Patients with a permanently pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departement de Cardiologie

Limoges, 87042, France

Location

Departement de Cardiologie

Montpellier, 34295, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 15, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations