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

This study has been completed.
Sponsor:
Collaborator:
Fédération Française de Cardiologie
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00774709
First received: October 16, 2008
Last updated: September 27, 2013
Last verified: September 2013

October 16, 2008
September 27, 2013
October 2008
October 2012   (final data collection date for primary outcome measure)
Echocardiographic parameter [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00774709 on ClinicalTrials.gov Archive Site
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Karolinska-Rennes (KaRen) Prospective Study of Exercise Stress Echocardiography in Heart Failure With Preserved Ejection Fraction
Ancillary Study of the Registry Karolinska-Rennes (KaRen) : Prospective Study of Dyssynchrony in Heart Failure With Preserved Ejection Fraction

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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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%)

Heart Failure
Not Provided
1
Donal E, Lund LH, Oger E, Hage C, Persson H, Reynaud A, Ennezat PV, Bauer F, Sportouch-Dukhan C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Baseline characteristics of patients with heart failure and preserved ejection fraction included in the Karolinska Rennes (KaRen) study. Arch Cardiovasc Dis. 2014 Feb;107(2):112-21. doi: 10.1016/j.acvd.2013.11.002. Epub 2013 Dec 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
  2. Known cause of right heart failure not related to left ventricular dysfunction
  3. Pericardial constriction
  4. Clinically significant pulmonary disease, as evidenced by requirement of current home oxygen
  5. End-stage renal disease currently requiring dialysis
  6. Bi-ventricular pacemaker (CRT). (Patients who have a conventional pacemaker may be included)
  7. 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).
  8. Anticipated percutaneous intervention on aortic stenosis. (Patients who undergo other percutaneous intervention, for example PCI, may be included).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00774709
CCP 08 / 20- 679
Yes
French Cardiology Society
French Cardiology Society
Fédération Française de Cardiologie
Principal Investigator: Erwan Donal, MD, PhD Service de Cardiologie - CHU Rennes
French Cardiology Society
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP