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Sponsors and Collaborators: |
French Cardiology Society Fédération Française de Cardiologie |
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Information provided by: | French Cardiology Society |
ClinicalTrials.gov Identifier: | NCT00774709 |
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 ng/L or NT-proBNP >300 ng/L. 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.
Condition |
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Heart Failure |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Ancillary Study of the Registry Karolinska-Rennes (KaRen) : Prospective Study of Dyssynchrony in Heart Failure With Preserved Ejection Fraction |
Estimated Enrollment: | 90 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients presenting acutely of congestive heart failure and diagnosed according to current ESC guidelines to have an heart failure with preserved ejection fraction (LV EF > or = 45%)
Inclusion Criteria:
Exclusion Criteria:
Contact: Erwan DONAL, MD, PhD | 33 6 17 70 85 67 | erwan.donal@chu-rennes.fr |
France | |
Service de Cardiologie et CIT-IC 804, LTSI INSERM U 642 | |
RENNES, France, 35033 |
Responsible Party: | Service de Cardiologie - CIT-IC 804, LTSI INSERM U ( DONAL Erwan, MD, PhD ) |
Study ID Numbers: | CCP 08 / 20- 679 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774709 |
Health Authority: | France: Ministry of Health |
Heart failure Preserved ejection fraction Diastolic dysfunction Dyssynchrony Echocardiography |
Patients with acute heart failure clinically diagnosed BNP level > 100 ng / l or NT-proBNP > 300 ng /l Preserved left ventricular ejection fraction(LVEF ≥ 45%) |
Heart Failure Heart Diseases Stress |
Cardiovascular Diseases |