Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

Congestive Heart Failure Clinical Trial

— KaRen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091467
• Other study ID #: 08140
• Status: Completed
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: August 2019
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Pontchaillou Hospital	Rennes
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Countries where clinical trial is conducted

France,  Sweden, 

References & Publications (17)

Bosseau C, Donal E, Lund LH, Oger E, Hage C, Mulak G, Daubert JC, Linde C; KaRen investigators. The prognostic significance of atrial fibrillation in heart failure with preserved ejection function: insights from KaRen, a prospective and multicenter study. — View Citation

Donal E, Lund L, Linde C, Daubert JC; KaRen investigators. Is cardiac resynchronization therapy an option in heart failure patients with preserved ejection fraction? Justification for the ongoing KaRen project. Arch Cardiovasc Dis. 2010 Jun-Jul;103(6-7):4 — View Citation

Donal E, Lund LH, Linde C, Edner M, Lafitte S, Persson H, Bauer F, Ohrvik J, Ennezat PV, Hage C, Löfman I, Juilliere Y, Logeart D, Derumeaux G, Gueret P, Daubert JC. Rationale and design of the Karolinska-Rennes (KaRen) prospective study of dyssynchrony i — View Citation

Donal E, Lund LH, Oger E, Bosseau C, Reynaud A, Hage C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Importance of combined left atrial size and estimated pulmonary pressure for clinical outcome in patients presenting with heart failure with preser — View Citation

Donal E, Lund LH, Oger E, Hage C, Persson H, Reynaud A, Ennezat PV, Bauer F, Drouet E, Linde C, Daubert C; KaRen investigators. New echocardiographic predictors of clinical outcome in patients presenting with heart failure and a preserved left ventricular — View Citation

Donal E, Lund LH, Oger E, Hage C, Persson H, Reynaud A, Ennezat PV, Bauer F, Sportouch-Dukhan C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Baseline characteristics of patients with heart failure and preserved ejection fraction included in the Ka — View Citation

Donal E, Lund LH, Oger E, Reynaud A, Schnell F, Persson H, Drouet E, Linde C, Daubert C; KaRen investigators. Value of exercise echocardiography in heart failure with preserved ejection fraction: a substudy from the KaRen study. Eur Heart J Cardiovasc Ima — View Citation

Faxén UL, Hage C, Donal E, Daubert JC, Linde C, Lund LH. Patient reported outcome in HFpEF: Sex-specific differences in quality of life and association with outcome. Int J Cardiol. 2018 Sep 15;267:128-132. doi: 10.1016/j.ijcard.2018.04.102. — View Citation

Hage C, Lund LH, Donal E, Daubert JC, Linde C, Mellbin L. Copeptin in patients with heart failure and preserved ejection fraction: a report from the prospective KaRen-study. Open Heart. 2015 Nov 3;2(1):e000260. doi: 10.1136/openhrt-2015-000260. eCollectio — View Citation

Hage C, Michaëlsson E, Linde C, Donal E, Daubert JC, Gan LM, Lund LH. Inflammatory Biomarkers Predict Heart Failure Severity and Prognosis in Patients With Heart Failure With Preserved Ejection Fraction: A Holistic Proteomic Approach. Circ Cardiovasc Gene — View Citation

Löfström U, Hage C, Savarese G, Donal E, Daubert JC, Lund LH, Linde C. Prognostic impact of Framingham heart failure criteria in heart failure with preserved ejection fraction. ESC Heart Fail. 2019 Aug;6(4):830-839. doi: 10.1002/ehf2.12458. Epub 2019 Jun — View Citation

Lund LH, Donal E, Oger E, Hage C, Persson H, Haugen-Löfman I, Ennezat PV, Sportouch-Dukhan C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Association between cardiovascular vs. non-cardiovascular co-morbidities and outcomes in heart failure with p — View Citation

Nagy AI, Hage C, Merkely B, Donal E, Daubert JC, Linde C, Lund LH, Manouras A. Left atrial rather than left ventricular impaired mechanics are associated with the pro-fibrotic ST2 marker and outcomes in heart failure with preserved ejection fraction. J In — View Citation

Najjar E, Faxén UL, Hage C, Donal E, Daubert JC, Linde C, Lund LH. ST2 in heart failure with preserved and reduced ejection fraction. Scand Cardiovasc J. 2019 Feb;53(1):21-27. doi: 10.1080/14017431.2019.1583363. Epub 2019 Mar 8. — View Citation

Persson H, Donal E, Lund LH, Matan D, Oger E, Hage C, Daubert JC, Linde C; KaRen Investigators. Importance of structural heart disease and diastolic dysfunction in heart failure with preserved ejection fraction assessed according to the ESC guidelines - A — View Citation

Savarese G, Donal E, Hage C, Oger E, Persson H, Daubert JC, Linde C, Lund LH; KaRen investigators. Changes in natriuretic peptides after acute hospital presentation for heart failure with preserved ejection fraction: A feasible surrogate trial endpoint? A — View Citation

Savarese G, Donal E, Hage C, Oger E, Persson H, Daubert JC, Linde C, Lund LH; KaRen investigators. Corrigendum to "Changes in natriuretic peptides after acute hospital presentation for heart failure with preserved ejection fraction: A feasible surrogate t — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rate	Analyse survival (all-cause death)	18 months
Secondary	Hospitalization for HF	Hospitalization for Heart Failure	18 months
Secondary	Cardiovascular death	Cardiovascular death	18 months