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Completed

NCT Number: NCT00774709

Karolinska-Rennes (KaRen) Prospective Study of Exercise Stress Echocardiography 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Disease Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Cardiologie et CIT-IC 804, LTSI INSERM U 642

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Echocardiographic parameter

    Time frame: 4 to 8 weeks

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • Fédération Française de Cardiologie

Registry information

Official study title

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

Acronym: KaRen

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2008
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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