Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

Completed

• Conditions: Congestive Heart Failure; Heart Failure With Preserved Ejection Fraction; Left Ventricular Ejection Fraction

• Registration Number: NCT01091467
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death rate	18 months	Analyse survival (all-cause death)

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	18 months	Cardiovascular death
Hospitalization for HF	18 months	Hospitalization for Heart Failure

Trial Locations

Locations (2)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Pontchaillou Hospital; 🇫🇷 Rennes, France