Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction (KaRen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091467
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Donal Erwan, French Cardiology Society

Brief Summary:
The purpose of this study is to examine electrical and echocardiographic characteristics and prognosis of consecutive patients admitted with acute heart failure and diagnosed to have heart failure with preserved ejection fraction (HFPEF).

Condition or disease
Congestive Heart Failure Left Ventricular Ejection Fraction Heart Failure With Preserved Ejection Fraction

Detailed Description:
  • Time 0: Patients will be screened at the time of presentation to the hospital at participating centres
  • Usually patients will be hospitalised for an acute dyspnea in relation with a pulmonary congestion. This congestion does not necessarily justify a hospitalization and for part of the patients a consultation and a dedicated treatment would be good enough to cure the symptoms.
  • Thus, patients seen in emergency for a congestion and diagnosed or known to have a preserved left ventricular ejection fraction (LV EF > 45%) will be proposed to participate to the study.
  • Patients meeting inclusion criteria will be invited back to the clinic in stable condition, approximately 4-8 weeks after the initial hospitalization.
  • Time 4-8 weeks after initial hospitalisation (NOT after discharge): Comprehensive history-taking and examinations.
  • Any information necessary for the study will be collected by the principal investigator in each participating center in a dedicated, secure, e-CRF. The access to the e-CRF will be restrictive to the only principal investigator of each center. The lonely other persons able to take look to the e-CRF are the study monitors.
  • Time 6, 12, and 18 months: Follow up by phone call or review of charts or other records such as death registries. This part of the study will be performed by the CRAs in the French Society of Cardiology

Study Type : Observational
Actual Enrollment : 362 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony
Study Start Date : October 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Patients with HF
Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45%

Primary Outcome Measures :
  1. Death rate [ Time Frame: 18 months ]
    Analyse survival (all-cause death)

Secondary Outcome Measures :
  1. Hospitalization for HF [ Time Frame: 18 months ]
    Hospitalization for Heart Failure

  2. Cardiovascular death [ Time Frame: 18 months ]
    Cardiovascular death

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the hospital with congestive heart failure

Inclusion Criteria:

  • Patient presenting to the hospital with congestive heart failure, defined as:

    1. Clinical signs of heart failure

      Major criteria

      • Paroxysmal nocturnal dyspnea
      • Orthopnea
      • Jugular venous distension
      • Pulmonary crackling rales
      • 3rd heart sound
      • Cardiothoracic ratio > 0.5 on X-ray
      • Pulmonary oedema on X-ray

      Minor Criteria

      • peripheral oedema
      • nocturnal cough
      • dyspnoea at exercise
      • hepatomegaly
      • pleural effusion
      • tachycardia (defined as ≥ 100 beats per minute)

      Heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria

    2. LVEF ≥ 45% by echocardiography within 72h
    3. 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 home oxygen.
  • End-stage renal disease requiring dialysis
  • Bi-ventricular pacemaker (CRT)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091467

Pontchaillou Hospital
Rennes, France, 35000
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
French Cardiology Society

Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Donal Erwan, Assistant Professor, French Cardiology Society Identifier: NCT01091467     History of Changes
Other Study ID Numbers: 08140
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Donal Erwan, French Cardiology Society:
Heart Failure
Ejection Fraction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases