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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: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Echocardiographic parameter [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2008
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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%)

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774709

Locations
France
Service de Cardiologie et CIT-IC 804, LTSI INSERM U 642
Rennes, France, 35033
Sponsors and Collaborators
French Cardiology Society
Fédération Française de Cardiologie
Investigators
Principal Investigator: Erwan Donal, MD, PhD Service de Cardiologie - CHU Rennes
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT00774709     History of Changes
Other Study ID Numbers: CCP 08 / 20- 679
Study First Received: October 16, 2008
Last Updated: November 20, 2012
Health Authority: France: Ministry of Health

Keywords provided by French Cardiology Society:
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%)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013