Ignite Creation Date:
2024-05-05 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00774709
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2008-10-16
Brief Title:
Karolinska-Rennes KaRen Prospective Study of Exercise Stress Echocardiography in Heart Failure With Preserved Ejection Fraction
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
Ancillary Study of the Registry Karolinska-Rennes KaRen Prospective Study of Dyssynchrony in Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KaRen
Brief Summary:
Background
Heart failure with preserved ejection fraction HFPEF is common but not well understood Electrical dyssynchrony in systolic heart failure is harmful Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF
Methods
We have designed a prospective multicentre international observational study to characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects prognosis Patients presenting with acute heart failure will be screened
Inclusion criteria will be
acute presentation with Framingham criteria for heart failure left ventricular EF 45 BNP 100 ngL or NT-proBNP 300 ngL Patients will return in stable condition 4-8 weeks after the index presentation and undergo questionnaires serology ECG and Dopplerechocardiography Thereafter patients will be followed for mortality and heart failure hospitalization every 6 months for at least 18 months Sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography
Conclusion
KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in the HFPEF The ancillary study of the exercise stress echocardiography sought to improve our understanding of HFPEF and generate answers to the question whether dyssynchrony could be a target for therapy in HFPEF
Heart failure with preserved ejection fraction HFPEF is common but not well understood Electrical dyssynchrony in systolic heart failure is harmful Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF
Methods
We have designed a prospective multicentre international observational study to characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects prognosis Patients presenting with acute heart failure will be screened
Inclusion criteria will be
acute presentation with Framingham criteria for heart failure left ventricular EF 45 BNP 100 ngL or NT-proBNP 300 ngL Patients will return in stable condition 4-8 weeks after the index presentation and undergo questionnaires serology ECG and Dopplerechocardiography Thereafter patients will be followed for mortality and heart failure hospitalization every 6 months for at least 18 months Sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography
Conclusion
KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in the HFPEF The ancillary study of the exercise stress echocardiography sought to improve our understanding of HFPEF and generate answers to the question whether dyssynchrony could be a target for therapy in HFPEF
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None