Karolinska-Rennes (KaRen) Prospective Study of Exercise Stress Echocardiography in Heart Failure With Preserved Ejection Fraction

Sponsor

French Cardiology Society (Other)

Overall Status

Completed

CT.gov ID

NCT00774709

Collaborator

Fédération Française de Cardiologie (Other)

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Heart Failure

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1

Outcome Measures

Primary Outcome Measures

Echocardiographic parameter [4 to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute presentation to the hospital with clinical signs and symptoms of HF, according to the Framingham criteria [19].
LVEF ≥ 45% by echocardiography within the first 72 hours. The measurement will be carried out according to guidelines
BNP >100 ng/L or NT-proBNP >300 ng/L.

Exclusion Criteria:

Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
Known cause of right heart failure not related to left ventricular dysfunction
Pericardial constriction
Clinically significant pulmonary disease, as evidenced by requirement of current home oxygen
End-stage renal disease currently requiring dialysis
Bi-ventricular pacemaker (CRT). (Patients who have a conventional pacemaker may be included)
Anticipated or indication for cardiac surgery. (Patients who have indication for surgery but may not undergo surgery because of some contraindication, for example age, may NOT be included).
Anticipated percutaneous intervention on aortic stenosis. (Patients who undergo other percutaneous intervention, for example PCI, may be included).