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Heart FailureKaRenNCT00774709

Karolinska-Rennes (KaRen) Prospective Study of Exercise Stress Echocardiography in Heart Failure With Preserved Ejection Fraction

An observational study of Heart Failure, run by French Cardiology Society at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Heart failure with preserved ejection fraction (HFPEF) is common but not well understood. Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
90 participants
Where
1 siteFrance
Study dates
Oct 2008to Nov 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients presenting acutely of congestive heart failure and diagnosed according to current ESC guidelines to have an heart failure with preserved ejection fraction (LV EF > or = 45%)

Who may be able to join

  • Acute presentation to the hospital with clinical signs and symptoms of HF, according to the Framingham criteria [19].
  • LVEF ≥ 45% by echocardiography within the first 72 hours. The measurement will be carried out according to guidelines
  • BNP >100 ng/L or NT-proBNP >300 ng/L.

Who cannot join

  • 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 current home oxygen
  • End-stage renal disease currently requiring dialysis
  • Bi-ventricular pacemaker (CRT). (Patients who have a conventional pacemaker may be included)
  • Anticipated or indication for cardiac surgery. (Patients who have indication for surgery but may not undergo surgery because of some contraindication, for example age, may NOT be included).
  • Anticipated percutaneous intervention on aortic stenosis. (Patients who undergo other percutaneous intervention, for example PCI, may be included).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Cardiologie et CIT-IC 804, LTSI INSERM U 642

    Rennes, 35033

Other trials in France

About this study

Official title: Ancillary Study of the Registry Karolinska-Rennes (KaRen) : Prospective Study of Dyssynchrony in Heart Failure With Preserved Ejection Fraction

Background:

Heart failure with preserved ejection fraction (HFPEF) is common but not well understood. Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF.

Read more

Methods:

We have designed a prospective, multicentre, international, observational study to characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects prognosis. Patients presenting with acute heart failure will be screened.

Inclusion criteria will be:

acute presentation with Framingham criteria for heart failure, left ventricular EF ≥45%, BNP >100 ng/L or NT-proBNP >300 ng/L. Patients will return in stable condition 4-8 weeks after the index presentation and undergo questionnaires, serology, ECG and Dopplerechocardiography. Thereafter, patients will be followed for mortality and heart failure hospitalization every 6 months for at least 18 months. Sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography.

Conclusion:

KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in the HFPEF. The ancillary study of the exercise stress echocardiography sought to improve our understanding of HFPEF and generate answers to the question whether dyssynchrony could be a target for therapy in HFPEF.

Conditions
Heart Failure
Keywords
Heart failure, Preserved ejection fraction, Diastolic dysfunction, Dyssynchrony, Echocardiography, Patients with acute heart failure clinically, diagnosed, BNP level > 100 ng / l or NT-proBNP > 300 ng /l, Preserved left ventricular ejection fraction(LVEF, ≥ 45%)
Medical subject headings
Heart Failure, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00774709
Study groupRoleWhat they receive
1Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Echocardiographic parameter

    Measured: 4 to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00774709
Sponsor's protocol ID
CCP 08 / 20- 679
Acronym
KaRen
Status last verified
Sep 2013
First submitted
16 Oct 2008
Last updated
30 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Hage C, Mang A, Daubert JC, Donal E, Myhre P, Linde C, Lund LH. Total NT-proBNP in heart failure with preserved vs reduced ejection fraction. Int J Cardiol. 2026 Sep 1;458:134554. doi: 10.1016/j.ijcard.2026.134554. Epub 2026 May 16.

    PubMed 42114780

  • Hage C, Mang A, Daubert JC, Donal E, Myhre PL, Linde C, Lund LH. Novel biomarkers distinguish heart failure with preserved vs reduced ejection fraction. ESC Heart Fail. 2026 May 5;13(3):xvaf011. doi: 10.1093/eschf/xvaf011.

    PubMed 41711204

  • Lund LH, Savarese G, Venkateshvaran A, Benson L, Lundberg A, Donal E, Daubert JC, Oger E, Linde C, Hage C. Eligibility of patients with heart failure with preserved ejection fraction for sacubitril/valsartan according to the PARAGON-HF trial. ESC Heart Fail. 2022 Feb;9(1):164-177. doi: 10.1002/ehf2.13705. Epub 2021 Nov 22.

    PubMed 34811954

  • Hage C, Wardell E, Linde C, Donal E, Lam CSP, Daubert C, Lund LH, Mansson-Broberg A. Circulating neuregulin1-beta in heart failure with preserved and reduced left ventricular ejection fraction. ESC Heart Fail. 2020 Apr;7(2):445-455. doi: 10.1002/ehf2.12615. Epub 2020 Jan 24.

    PubMed 31981321

  • Hage C, Bjerre M, Frystyk J, Gu HF, Brismar K, Donal E, Daubert JC, Linde C, Lund LH. Comparison of Prognostic Usefulness of Serum Insulin-Like Growth Factor-Binding Protein 7 in Patients With Heart Failure and Preserved Versus Reduced Left Ventricular Ejection Fraction. Am J Cardiol. 2018 Jun 15;121(12):1558-1566. doi: 10.1016/j.amjcard.2018.02.041. Epub 2018 Mar 14.

    PubMed 29622288

  • 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.

    PubMed 29430747

  • 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.

    PubMed 28329385

  • 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.

    PubMed 28100627

  • 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.

    PubMed 28028584

  • 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.

    PubMed 26568833

  • 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.

    PubMed 24388161

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by French Cardiology Society at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Echocardiographic parameter (time frame: 4 to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00774709, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.

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