CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00774709
NCT00774709N/ACompleted

Ancillary Study of the Registry Karolinska-Rennes (KaRen) : Prospective Study of Dyssynchrony in Heart Failure With Preserved Ejection Fraction

French Cardiology Society·observational·Posted Oct 17, 2008·Updated Sep 30, 2013

In Brief

An observational study for Heart Failure. Completed, enrolled 90 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesFrance

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.7 years ago