Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction (KaRen)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01091467|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : November 24, 2017
|Condition or disease|
|Congestive Heart Failure Left Ventricular Ejection Fraction Heart Failure With Preserved Ejection Fraction|
- 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
|Study Type :||Observational|
|Actual Enrollment :||362 participants|
|Official Title:||Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony|
|Study Start Date :||October 2008|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Patients with HF
Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45%
- Death rate [ Time Frame: 18 months ]Analyse survival (all-cause death)
- Hospitalization for HF [ Time Frame: 18 months ]Hospitalization for Heart Failure
- Cardiovascular death [ Time Frame: 18 months ]Cardiovascular death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091467
|Rennes, France, 35000|
|Karolinska University Hospital|