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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donal Erwan, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01091467
First received: March 8, 2010
Last updated: September 27, 2013
Last verified: September 2013

March 8, 2010
September 27, 2013
October 2008
December 2012   (final data collection date for primary outcome measure)
Death rate [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Analyse survival (all-cause death)
Same as current
Complete list of historical versions of study NCT01091467 on ClinicalTrials.gov Archive Site
  • Hospitalization for HF [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Hospitalization for Heart Failure
  • Cardiovascular death [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Cardiovascular death
Same as current
Not Provided
Not Provided
 
Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction
Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony

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).

  • 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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients presenting to the hospital with congestive heart failure

  • Congestive Heart Failure
  • Left Ventricular Ejection Fraction
  • Heart Failure With Preserved Ejection Fraction
Not Provided
Patients with HF
Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Sweden
 
NCT01091467
08140
Yes
Donal Erwan, French Cardiology Society
French Cardiology Society
Not Provided
Not Provided
French Cardiology Society
September 2013

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