Left-sided Congestive Heart FailureCOLLAG4NCT01677494
Collagen Markers in Heart Failure and Preserved Ejection Fraction
An observational study of Left-sided Congestive Heart Failure, run by University Hospital, Rouen at 1 site in France.
Trial summary
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Left-sided Congestive Heart Failure
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Aug 2013
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: heart failure with preserved ejection fraction
- inclusion Signs of heart failure Elevated BNP EF > 50% within 72 hours after admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics
Read the detailed description
Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection fraction, which represents half of admission has today no efficient treatment.
Fibrosis is found in heart of patients with HF and preserved ejection fraction, is reponsible for stiff heart and has link to the transition to compensated/decompaseted HF and death.
The purpose of this work is to characterise myocardial fibrosis by any means to change the prognosis of patients with HF and preserved ejection fraction
Main purpose:
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics
- Patients selection
- - Inclusion Criteria: Male or female > 18 and < 85 years of age. Recent HF decompensation (framingham criteria, ejection fraction > 50% with 72 hours after admission and BNP > 100 ng/L or NT-proBNP > 300 ng/L), signed inform consent.
- - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.
- Control group
- - inclusion criteria: Male or female > 18 and < 85 years of age. signed inform consent. Health insurance.
- - exclusion criteria: significant ischemic heart disease, significant valvular heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.
- Conditions
- Left-sided Congestive Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| heart failure with preserved ejection fraction | - Inclusion Elevated BNP EF > 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
death and admission for heart failure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left-sided Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Bauer, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677494
- Sponsor's protocol ID
- 2010/068/HP
- Acronym
- COLLAG4
- Status last verified
- Sep 2014
- First submitted
- 2 Dec 2010
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.
- ClinicalTrials.gov ID
- NCT01677494
- Acronym / sponsor ID
- COLLAG4 / 2010/068/HP
- Conditions
- Left-sided Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Sep 2012 (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.
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics
Detailed description
Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection fraction, which represents half of admission has today no efficient treatment.
Fibrosis is found in heart of patients with HF and preserved ejection fraction, is reponsible for stiff heart and has link to the transition to compensated/decompaseted HF and death.
The purpose of this work is to characterise myocardial fibrosis by any means to change the prognosis of patients with HF and preserved ejection fraction
Main purpose:
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics
- Patients selection
- - Inclusion Criteria: Male or female > 18 and < 85 years of age. Recent HF decompensation (framingham criteria, ejection fraction > 50% with 72 hours after admission and BNP > 100 ng/L or NT-proBNP > 300 ng/L), signed inform consent.
- - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.
- Control group
- - inclusion criteria: Male or female > 18 and < 85 years of age. signed inform consent. Health insurance.
- - exclusion criteria: significant ischemic heart disease, significant valvular heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heart failure with preserved ejection fraction | – | –- Inclusion Elevated BNP EF > 50% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- heart failure with preserved ejection fraction
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
death and admission for heart failure
Time frame: 2 years
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Fabrice Bauer, MD, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left-sided Congestive Heart Failure, run by University Hospital, Rouen 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?
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 3 Sep 2014. 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 was stopped early (reason given: lack of recruitment). 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?
death and admission for heart failure (time frame: 2 years). 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 3 Sep 2014.