Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction (KaRen)
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).
Congestive Heart Failure
Left Ventricular Ejection Fraction
Heart Failure With Preserved Ejection Fraction
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony|
- Death rate [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Analyse survival (all-cause death)
- Hospitalization for HF [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Hospitalization for Heart Failure
- Cardiovascular death [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Cardiovascular death
|Study Start Date:||October 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Patients with HF
Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45%
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091467
|Rennes, France, 35000|
|Karolinska University Hospital|