Clinical Trials Directory

Trials / Completed

CompletedNCT01091467

Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony

Status
Completed
Phase
Study type
Observational
Enrollment
362 (actual)
Sponsor
French Cardiology Society · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to examine electrical and echocardiographic characteristics and prognosis of consecutive patients admitted with acute heart failure and diagnosed to have heart failure with preserved ejection fraction (HFPEF).

Detailed description

* Time 0: Patients will be screened at the time of presentation to the hospital at participating centres * Usually patients will be hospitalised for an acute dyspnea in relation with a pulmonary congestion. This congestion does not necessarily justify a hospitalization and for part of the patients a consultation and a dedicated treatment would be good enough to cure the symptoms. * Thus, patients seen in emergency for a congestion and diagnosed or known to have a preserved left ventricular ejection fraction (LV EF \> 45%) will be proposed to participate to the study. * Patients meeting inclusion criteria will be invited back to the clinic in stable condition, approximately 4-8 weeks after the initial hospitalization. * Time 4-8 weeks after initial hospitalisation (NOT after discharge): Comprehensive history-taking and examinations. * Any information necessary for the study will be collected by the principal investigator in each participating center in a dedicated, secure, e-CRF. The access to the e-CRF will be restrictive to the only principal investigator of each center. The lonely other persons able to take look to the e-CRF are the study monitors. * Time 6, 12, and 18 months: Follow up by phone call or review of charts or other records such as death registries. This part of the study will be performed by the CRAs in the French Society of Cardiology

Conditions

Timeline

Start date
2008-10-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2010-03-24
Last updated
2019-08-08

Locations

2 sites across 2 countries: France, Sweden

Source: ClinicalTrials.gov record NCT01091467. Inclusion in this directory is not an endorsement.