Heart DecompensationPro-ICARDNCT02859636
Pronostic Value of Endothelial Dysfunction in Heart Failure
An observational study of Heart Decompensation and Cardiac Failure, run by Centre Hospitalier Universitaire de Besancon.
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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Heart Decompensation, Cardiac Failure
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Mar 2016
- 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 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with more than 18 years and less than 81 years, hospitalized for acute heart failure with left ventricular impairment (LVEF < 45%)
Who may be able to join
- patients hospitalized for acute heart fialure with Left Ventricular Ejection Fraction (LVEF) < 45 % on echocardiography
Who cannot join
- 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
About this study
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.
- Conditions
- Heart Decompensation, Cardiac Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
MR Proadrenomedulline
Measured: 6 months
catecholamins
Measured: 6 months
Measured: 6 months
late endothelial progenitors
Measured: 6 months
Peripheral tissular perfusion
Near infra-red spectroscopy
Measured: 6 months
mortality
Measured: 6 months
hospitalisation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startOct 2012
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Not enough inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859636
- Sponsor's protocol ID
- P/2012/140
- Acronym
- Pro-ICARD
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pronostic Value of Endothelial Dysfunction in Heart Failure
- ClinicalTrials.gov ID
- NCT02859636
- Acronym / sponsor ID
- Pro-ICARD / P/2012/140
- Conditions
- Heart Decompensation, Cardiac Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough inclusions
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with more than 18 years and less than 81 years, hospitalized for acute heart failure with left ventricular impairment (LVEF < 45%)
Key inclusion criteria (1 listed)
- patients hospitalized for acute heart fialure with Left Ventricular Ejection Fraction (LVEF) < 45 % on echocardiography
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MR Proadrenomedulline
Time frame: 6 months
catecholamins
Time frame: 6 months
Time frame: 6 months
late endothelial progenitors
Time frame: 6 months
Peripheral tissular perfusion
Time frame: 6 months
Near infra-red spectroscopy
mortality
Time frame: 6 months
hospitalisation
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Not enough inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
Related trials for Heart Decompensation
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
Recruiting
Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
Heart Failure; With Decompensation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Decompensation and Cardiac Failure, run by Centre Hospitalier Universitaire de Besancon.
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 1 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: stopped early, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Not enough inclusions). Results are not available in the source record.
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?
MR Proadrenomedulline (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016.