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
  Purpose

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
Congestive Heart Failure
Left Ventricular Ejection Fraction
Heart Failure With Preserved Ejection Fraction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Death rate [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Analyse survival (all-cause death)


Secondary Outcome Measures:
  • 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


Enrollment: 362
Study Start Date: October 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with HF
Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45%

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
  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 to the hospital with congestive heart failure

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091467

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donal Erwan, Assistant Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01091467     History of Changes
Other Study ID Numbers: 08140
Study First Received: March 8, 2010
Last Updated: September 27, 2013
Health Authority: France : National Commission on Informatics and Freedoms

Keywords provided by French Cardiology Society:
Heart Failure
Ejection Fraction
Echocardiography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014