- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859636
Pronostic Value of Endothelial Dysfunction in Heart Failure (Pro-ICARD)
August 4, 2016 updated by: Centre Hospitalier Universitaire de Besancon
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
7
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with more than 18 years and less than 81 years, hospitalized for acute heart failure with left ventricular impairment (LVEF < 45%)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mortality
Time Frame: 6 months
|
6 months
|
|
|
MR Proadrenomedulline
Time Frame: 6 months
|
6 months
|
|
|
catecholamins
Time Frame: 6 months
|
6 months
|
|
|
Time Frame: 6 months
|
6 months
|
|
|
late endothelial progenitors
Time Frame: 6 months
|
6 months
|
|
|
Peripheral tissular perfusion
Time Frame: 6 months
|
Near infra-red spectroscopy
|
6 months
|
|
hospitalisation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
August 2, 2016
First Submitted That Met QC Criteria
August 4, 2016
First Posted (Estimate)
August 9, 2016
Study Record Updates
Last Update Posted (Estimate)
August 9, 2016
Last Update Submitted That Met QC Criteria
August 4, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2012/140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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