Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

NCT ID: NCT01091467

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 362 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-12-31

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with HF

Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45%

No interventions assigned to this group

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Donal Erwan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pontchaillou Hospital

Rennes, , France

Karolinska University Hospital

Stockholm, , Sweden

Countries

France; Sweden

References

Donal E, Lund LH, Linde C, Edner M, Lafitte S, Persson H, Bauer F, Ohrvik J, Ennezat PV, Hage C, Lofman I, Juilliere Y, Logeart D, Derumeaux G, Gueret P, Daubert JC. Rationale and design of the Karolinska-Rennes (KaRen) prospective study of dyssynchrony in heart failure with preserved ejection fraction. Eur J Heart Fail. 2009 Feb;11(2):198-204. doi: 10.1093/eurjhf/hfn025.

Reference Type: RESULT

PMID: 19168519 (View on PubMed)

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):404-10. doi: 10.1016/j.acvd.2010.01.009. Epub 2010 Jun 23.

Reference Type: RESULT

PMID: 20800804 (View on PubMed)

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 Karolinska Rennes (KaRen) study. Arch Cardiovasc Dis. 2014 Feb;107(2):112-21. doi: 10.1016/j.acvd.2013.11.002. Epub 2013 Dec 30.

Reference Type: RESULT

PMID: 24388161 (View on PubMed)

Lund LH, Donal E, Oger E, Hage C, Persson H, Haugen-Lofman 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 preserved ejection fraction. Eur J Heart Fail. 2014 Sep;16(9):992-1001. doi: 10.1002/ejhf.137. Epub 2014 Jul 21.

Reference Type: RESULT

PMID: 25046483 (View on PubMed)

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 ejection fraction: a subanalysis of the Ka (Karolinska) Ren (Rennes) Study. Eur J Heart Fail. 2015 Jul;17(7):680-8. doi: 10.1002/ejhf.291. Epub 2015 May 29.

Reference Type: RESULT

PMID: 26033771 (View on PubMed)

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 Imaging. 2016 Jan;17(1):106-13. doi: 10.1093/ehjci/jev144. Epub 2015 Jun 16.

Reference Type: RESULT

PMID: 26082167 (View on PubMed)

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. eCollection 2015.

Reference Type: RESULT

PMID: 26568833 (View on PubMed)

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 report from the prospective Karen study. Int J Cardiol. 2017 Jan 1;226:65-70. doi: 10.1016/j.ijcard.2016.10.035. Epub 2016 Oct 17.

Reference Type: RESULT

PMID: 27788392 (View on PubMed)

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. Heart Vessels. 2017 Jun;32(6):735-749. doi: 10.1007/s00380-016-0933-8. Epub 2016 Dec 27.

Reference Type: RESULT

PMID: 28028584 (View on PubMed)

Hage C, Michaelsson 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 Genet. 2017 Feb;10(1):e001633. doi: 10.1161/CIRCGENETICS.116.001633.

Reference Type: RESULT

PMID: 28100627 (View on PubMed)

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 preserved ejection fraction. Eur Heart J Cardiovasc Imaging. 2017 Jun 1;18(6):629-635. doi: 10.1093/ehjci/jex005.

Reference Type: RESULT

PMID: 28329385 (View on PubMed)

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 Intern Med. 2018 Apr;283(4):380-391. doi: 10.1111/joim.12723. Epub 2018 Feb 12.

Reference Type: RESULT

PMID: 29430747 (View on PubMed)

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 trial endpoint? A report from the prospective Karen study" [Int. J. Cardiol. 226 (2017) 65-70]. Int J Cardiol. 2018 Jun 15;261:240. doi: 10.1016/j.ijcard.2018.03.075. Epub 2018 Mar 27. No abstract available.

Reference Type: RESULT

PMID: 29602583 (View on PubMed)

Faxen 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.

Reference Type: RESULT

PMID: 29957252 (View on PubMed)

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 substudy in the Ka (Karolinska) Ren (Rennes) study. Int J Cardiol. 2019 Jan 1;274:202-207. doi: 10.1016/j.ijcard.2018.06.078. Epub 2018 Jun 20.

Reference Type: RESULT

PMID: 30049496 (View on PubMed)

Lofstrom 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 17.

Reference Type: RESULT

PMID: 31207140 (View on PubMed)

Najjar E, Faxen 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.

Reference Type: RESULT

PMID: 30776920 (View on PubMed)

Donal E, Thebault C, Lund LH, Kervio G, Reynaud A, Simon T, Drouet E, Nonotte E, Linde C, Daubert JC. Heart failure with a preserved ejection fraction additive value of an exercise stress echocardiography. Eur Heart J Cardiovasc Imaging. 2012 Aug;13(8):656-65. doi: 10.1093/ehjci/jes010. Epub 2012 Jan 29.

Reference Type: DERIVED

PMID: 22291430 (View on PubMed)

Other Identifiers

08140

Identifier Type: -

Identifier Source: org_study_id