Congestive Heart FailureLOOP-HFNCT03422991
Cohort of Heart Failure Patients
A study testing Blood sampling and Quality of life questionnaire. in people with Congestive Heart Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Blood sampling and Quality of life questionnaire.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2017to 16 Jan 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with congestive heart failure confirmed during
- Hospitalization for cardiac decompensation
- A medical follow-up for stable congestive heart failure with at least one cardiac decompensation event
- NT-proBNP > 500 ng/l in the month before Baseline (or BNP > 150 ng/l)
- NYHA ≥ 2
- Aged over 18
- Signature of the informed consent
Who cannot join
- Life expectancy shorter than a month
- Patients on long term assistance or with heart transplant
- Impossibility to give patients clear information
- Loss of autonomy, dementia, major dependence
- Patients without health coverage
- Patient with no legal protection
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique
Lyon
About this study
Official title: Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure
This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects.
Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its prognosis stays pejorative despite years of major therapeutical progress. In recent trials, all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years.
Read more
Medical care of congestive heart failure is based on precise international recommendations. The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid receptor antagonists, represent the basis of the pharmacological treatment.
Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional efficient treatments that reduce events in appropriately selected patients.
Despite these improvements, the prognostic of congestive heart failure in registers is worse than those observed in randomized trials. This can be explained by differences in congestive heart failure patient populations and/or by a less rigorous medical care where treatments are not optimized.
The evaluation of medical care in congestive heart failure is today of utmost importance.
Integrating new pharmacological molecules, medical devices and the application of new recommendations have major interest for documentation and practical changes.
The main objective of this cohort will be to evaluate the evolution of the 12-month quality of life score of a HF patient and the characteristics and treatments associated with it.
- Conditions
- Congestive Heart Failure
- Being tested
- Blood sampling and Quality of life questionnaire.
- Keywords
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Cohort
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and Quality of life questionnaire.Other
Blood sampling and Quality of life questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Congestive Heart Failure patients Cohort | Other | Cluster of patients with congestive heart failure NYHA ≥2, with at least one cardiac decompensation, NT-proBNP (N-terminal pro-brain natriuretic peptide) > 500 ng/l. Will be followed during 18 months. Receives: Other: Blood sampling and Quality of life questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
Measurement of quality of life of patients with heart failure: patient will answer to this questionnaire (Mobility, Autonomy of the person, Current activities, Pain ,Anxiéty/Depression)
) at baseline and at 12th month visit. The evolution between these two scores will be analysed .
Measured: 12 months
Secondary outcomes (14)
Renal function : glomerular filtration rate
Assessing the renal function evolution of patients with heart failure the glomerular filtration rate will be calculated according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula.
Measured: Baseline
Renal function : glomerular filtration rate
Assessing the renal function evolution of patients with heart failure the glomerular filtration rate will be calculated according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula.
Measured: 2 months
NT-proBNP
Measure of NT-proBNP will be done at 18th month in order to correlate the effect of low blood pression and renal function decreasing on NT-proBNP variability
Measured: 18 months
number of death (all-cause)
Measured: 18 months
number of all cardiovascular cause death
Measured: 18 months
number all unscheduled hospitalization for heart failure
Measured: 18 months
number of stroke
Measured: 18 months
nonfatal myocardial infarction
Measured: 18 months
cardiac assistance or heart transplantation
Measured: 18 months
symptomatic hypotension
Measured: 18 months
number of dialysis
Measured: 18 months
number ventricular arrhythmias
(ventricular tachycardia and ventricular fibrillation)
Measured: 18 months
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Measured: Baseline, 6, 12 and 18 months
Cardiac function
Cardiac function will be evaluated on Echography Trans Thoracic at baseline and at the 12 months visit.
- Left Ventricular Ejection Fraction
- levitation pressure filling (yes/No)
- Right ventricular dysfunction (yes/no)
- pulmonary artery systolic pressure (mmHg)
- right atrial pressure
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start15 Dec 2017
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422991
- Sponsor's protocol ID
- 69HCL17_0250
- Acronym
- LOOP-HF
- Status last verified
- Nov 2024
- First submitted
- 12 Jan 2018
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT03422991
- Acronym / sponsor ID
- LOOP-HF / 69HCL17_0250
- Conditions
- Congestive Heart Failure
- Keywords
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Cohort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 6 Feb 2018 (actual)
- 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.
This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects.
Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its prognosis stays pejorative despite years of major therapeutical progress. In recent trials, all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years.
Medical care of congestive heart failure is based on precise international recommendations. The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid receptor antagonists, represent the basis of the pharmacological treatment.
Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional efficient treatments that reduce events in appropriately selected patients.
Despite these improvements, the prognostic of congestive heart failure in registers is worse than those observed in randomized trials. This can be explained by differences in congestive heart failure patient populations and/or by a less rigorous medical care where treatments are not optimized.
The evaluation of medical care in congestive heart failure is today of utmost importance.
Integrating new pharmacological molecules, medical devices and the application of new recommendations have major interest for documentation and practical changes.
The main objective of this cohort will be to evaluate the evolution of the 12-month quality of life score of a HF patient and the characteristics and treatments associated with it.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congestive Heart Failure patients Cohort | Other | Other: Blood sampling and Quality of life questionnaire.Cluster of patients with congestive heart failure NYHA ≥2, with at least one cardiac decompensation, NT-proBNP (N-terminal pro-brain natriuretic peptide) > 500 ng/l. Will be followed during 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with congestive heart failure confirmed during
- NT-proBNP > 500 ng/l in the month before Baseline (or BNP > 150 ng/l)
- NYHA ≥ 2
- Aged over 18
- Signature of the informed consent
Key exclusion criteria (7 listed)
- Life expectancy shorter than a month
- Patients on long term assistance or with heart transplant
- Impossibility to give patients clear information
- Loss of autonomy, dementia, major dependence
- Patients without health coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling and Quality of life questionnaire.Blood sampling and Quality of life questionnaire. | Other | Congestive Heart Failure patients Cohort |
Primary outcome
Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
Time frame: 12 months
Measurement of quality of life of patients with heart failure: patient will answer to this questionnaire (Mobility, Autonomy of the person, Current activities, Pain ,Anxiéty/Depression) ) at baseline and at 12th month visit. The evolution between these two scores will be analysed .
14 secondary outcomes
Renal function : glomerular filtration rate
Time frame: Baseline
Renal function : glomerular filtration rate
Time frame: 2 months
NT-proBNP
Time frame: 18 months
number of death (all-cause)
Time frame: 18 months
number of all cardiovascular cause death
Time frame: 18 months
number all unscheduled hospitalization for heart failure
Time frame: 18 months
number of stroke
Time frame: 18 months
nonfatal myocardial infarction
Time frame: 18 months
cardiac assistance or heart transplantation
Time frame: 18 months
symptomatic hypotension
Time frame: 18 months
number of dialysis
Time frame: 18 months
number ventricular arrhythmias
Time frame: 18 months
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Time frame: Baseline, 6, 12 and 18 months
Cardiac function
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Quality of life questionnaire. in people with Congestive Heart Failure, run by Hospices Civils de Lyon 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?
The sponsor lists 7 inclusion and 7 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: finished, as of the sponsor's last update on 18 Nov 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months (time frame: 12 months). 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 18 Nov 2024.