KaRen - Karolinska-Rennes Cohort: Cardiac Dyssynchrony in Patients with Heart Failure and Preserved Ejection Fraction
Head :
Daubert Jean-Claude, Centre Cardio-Pneumologique, Hôpital Pontchaillou, CHU de Rennes
Donal Erwan, Service de Cardiologie et CIC-IT 804 – LTSIINSERM U 642Hôpital Pontchaillou
Donal Erwan, Service de Cardiologie et CIC-IT 804 – LTSIINSERM U 642Hôpital Pontchaillou
Last update : 08/06/2015 | Version : 2 | ID : 8678
| General | |
| Identification | |
| Detailed name | Karolinska-Rennes Cohort: Cardiac Dyssynchrony in Patients with Heart Failure and Preserved Ejection Fraction |
| Sign or acronym | KaRen |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. 908071 on 23/03/2009 |
| General Aspects | |
| Medical area |
Cardiology |
| Keywords | atrial arrhythmia, left ventricular ejection fraction, HF, heart failure, LVEF, prognosis, prevalence |
| Scientific investigator(s) (Contact) | |
| Name of the director | Daubert |
| Surname | Jean-Claude |
| Address | CHU de Rennes, Centre de Cardio-Pneumologie, 35033 Rennes, France |
| jean-claude.daubert@chu-rennes.fr | |
| Unit | Centre Cardio-Pneumologique, Hôpital Pontchaillou, CHU de Rennes |
| Organization | CHU |
| Name of the director | Donal |
| Surname | Erwan |
| Address | Hôpital Pontchaillou, CHU de Rennes, 35033 Rennes France |
| erwan.donal@chu-rennes.fr | |
| Unit | Service de Cardiologie et CIC-IT 804 – LTSIINSERM U 642Hôpital Pontchaillou |
| Organization | CHU de |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | French Cardiology Society |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société Française de Cardiologie |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | The main aim is to test the prognostic value of electrical or mechanical cardiac dyssynchrony and to determine prevalence and characteristics in patients with heart failure and preserved left ventricular ejection fraction. |
| Inclusion criteria |
- Hospital visit OR hospitalisation for heart failure symptom;
- Clinical signs of HF: - HF according to the Framingham criteria: 2 major criteria or 1 major + 2 minor criteria; - LVEF (Left Ventricular Fraction) greater or equal to 45% by echocardiography; - NT-proBNP greater than 300 pg/mL or BNP greater than 100. Exclusion criteria: - Evidence of primary hypertrophic or restrictive cardiomyopathy, or systemic illness known to be associated with infiltrative heart disease; - Known right heart failure by pulmonary or pulmonary vascular disease not related to the left heart; - Pericardial constriction; - Restrictive or obstructive pulmonary disease, as evidenced by the requirement for home oxygen; - End-stage renal disease currently requiring dialysis; - Bi-ventricular pacemaker (CRT-P + ICD); - Acute coronary syndrome. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | Sweden and France (Bordeaux, Créteil, Lille, Lyon, Marseilles, Montpellier, Nantes, Rennes, Paris, Rouen, Nancy). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2008 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 362 (May 2012) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Treatment, medical history. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Quality of life questionnaire. |
| Paraclinical data (detail) | Electrocardiogram. |
| Biological data (detail) | Standard biology + NT-proBNP or BNP. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up at 4-8 weeks (treatment, events since enrolment, vital status, medical examination and quality of life questionnaire), 6 months, 12 months and 18 months. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/HAL-KAREN |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-Karen |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Results via publications. Contact the scientist in charge for further information. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
