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NCT02859636 Clinical Trial

Pronostic Value of Endothelial Dysfunction in Heart Failure

Cardiac Failure Clinical Trial

— Pro-ICARD  

Official title:
Pronostic Value of Endothelial Dysfunction in Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02859636
Other study ID # P/2012/140
Secondary ID
Status Terminated
Phase N/A
First received August 2, 2016
Last updated August 4, 2016
Start date October 2012
Est. completion date March 2016

Study information
Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

The main objective is to evaluate the pronostic value of endothelial dysfonction in acute heart failure on a combined criteria associating cardiovascular mortality, nex hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2 month and 1 year before acute heart failure.

Recruitment information / eligibility
Status Terminated
Enrollment 7
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 81 Years
Eligibility Inclusion Criteria:

- patients hospitalized for acute heart fialure with Left Ventricular Ejection Fraction (LVEF) < 45 % on echocardiography

Exclusion Criteria:

- Informed consent form not signed

- Cardiogenic, septic or hemorragic shock

- Acute coronary syndrom with elevated troponin

- valvular surgery or aorto-coronary graft during next 3 months

- Cancer

- Pregnancy

- life expectancy over than 1 year

- chronic renal impairment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary MR Proadrenomedulline 6 months No
Primary catecholamins 6 months No
Primary late endothelial progenitors 6 months No
Primary Peripheral tissular perfusion Near infra-red spectroscopy 6 months No
Primary mortality 6 months No
Primary hospitalisation 6 months No
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