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Completed

NCT Number: NCT01091467

Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pontchaillou Hospital, Rennes, France

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • LVEF ≥ 45% by echocardiography within 72h
  • 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)

Treatment and study plan

Primary outcomes

  1. Death rate

    Time frame: 18 months

    Analyse survival (all-cause death)

Secondary outcomes

  1. Hospitalization for HF

    Time frame: 18 months

    Hospitalization for Heart Failure

  2. Cardiovascular death

    Time frame: 18 months

    Cardiovascular death

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony

Acronym: KaRen

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 24, 2010
Registry last updated
Aug 8, 2019

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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