Severe Heart FailureEFFICARDNCT02763670
Patient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France.
A study testing PRETICARD patient care management and "As usual " patient care management in people with Severe Heart Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Heart Failure
- What is being tested?
- PRETICARD patient care management and "As usual " patient care management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure patient with left ventricular ejection fraction (LVEF) defined by an impaired LVEF less than or equal to 40%.
- Heart failure stage III or IV NYHA, or heart failure patients with stage II NYHA with previous hospitalization for heart failure.
- Patient who has received a written or oral information of the study
- Patient affiliated with French health Insurance
Who cannot join
- Patient refusal to participate in the study
- Progressive neoplastic pathology.
- Patient with impaired cognitive functions known.
- Patient subject to a measure of socio-legal protection.
- Heart failure secondary to curable causes (an arrhythmia, valvular dysfunction, myocardial infarction, bypass surgery scheduled, aortic stenosis, breaking rope…)
- Dyspnea pulmonary origin: pulmonary arterial hypertension pre-capillary origin catheterization, defined by a Pcap ≤15 mmHg.
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- Patient who underwent ventricular mechanical assistance.
- Patient with acute breathlessness is explained by: a severe lung infection (CPT <60% of predicted, ventricular ejection fraction <60% predicted) or pulmonary embolism or respiratory failure with ambient air PaO2 (arterial oxygen pressure) below 60 mmHg or oxygen therapy.
- Dialysis patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.
The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.
Read more
This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.
The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.
The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.
- Conditions
- Severe Heart Failure
- Being tested
- PRETICARD patient care management, "As usual " patient care management
- Keywords
- Heart failure, patient education as topic, patient care management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRETICARD patient care managementOther
A standardized and specialized network to take care of the severe cardiac insufficiency:
- An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
- At 1 months, consultations and acts realized by health professionals specialized (one hospital day care)
- At 2 months, a therapeutic education program for heart failure patients, approved by the Rhône-Alpes regional public health authorities (week hospital: two days and one night).
- At 6 and 18 months, one cardiology consultation
- At 12 and 24 months, consultations and acts realized by health professionals specialized (one hospital day care)
"As usual " patient care managementOther
Conventional management of heart failure patients is defined in the guide HAS ("Haute Autorité de Santé") care course. Patient follow-up, however, is defined by the patient's physician and / or cardiologist at the waning of his hospitalization, according to the usual practice for patients with stage II, III or IV NYHA.
According to these recommendations, the patient should see his cardiologist at least once a year.
Usual practices are:
- An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
- At 12 months, a cardiologic consultation. For the study, three evaluation points are programmed: two by phone at 6 and 18 months, two by a consultation at 24 months. This interview aimed to evaluate the number of hospitalization, consultations and acts realized by health professionals specialized (the information in the logbook).
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | PRETICARD patient care management Receives: Other: PRETICARD patient care management |
| Control | Other | Heterogenous "as usual" patient care management. Receives: Other: "As usual " patient care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.
Measured: 12 months
Secondary outcomes (4)
Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.
Measured: At 6, 18 and 24 months
Quality of life.
MINNESOTA Questionnaire.
Measured: 12 months
Satisfaction.
Semi-structured interviews.
Measured: 3 months
Cost of medical care
Identification of expenditure:
- Hospitalizations
- Consultations (inpatient and outpatient)
- Biology and imaging
- Medical transport
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 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
- NCT02763670
- Sponsor's protocol ID
- 2013.838
- Acronym
- EFFICARD
- Status last verified
- Feb 2018
- First submitted
- 3 May 2016
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.
- ClinicalTrials.gov ID
- NCT02763670
- Acronym / sponsor ID
- EFFICARD / 2013.838
- Conditions
- Severe Heart Failure
- Keywords
- Heart failure, patient education as topic, patient care management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 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 heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.
The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.
This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.
The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.
The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Other: PRETICARD patient care managementPRETICARD patient care management |
| Control | Other | Other: "As usual " patient care managementHeterogenous "as usual" patient care management. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic heart failure patient with left ventricular ejection fraction (LVEF) defined by an impaired LVEF less than or equal to 40%.
- Heart failure stage III or IV NYHA, or heart failure patients with stage II NYHA with previous hospitalization for heart failure.
- Patient who has received a written or oral information of the study
- Patient affiliated with French health Insurance
Key exclusion criteria (9 listed)
- Patient refusal to participate in the study
- Progressive neoplastic pathology.
- Patient with impaired cognitive functions known.
- Patient subject to a measure of socio-legal protection.
- Heart failure secondary to curable causes (an arrhythmia, valvular dysfunction, myocardial infarction, bypass surgery scheduled, aortic stenosis, breaking rope…)
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 |
|---|---|---|
| PRETICARD patient care managementA standardized and specialized network to take care of the severe cardiac insufficiency: * An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency * At 1 months, consultations and acts realized by health professionals specialized (one hospital day care) * At 2 months, a therapeutic education program for heart failure patients, approved by the Rhône-Alpes regional public health authorities (week hospital: two days and one night). * At 6 and 18 months, one cardiology consultation * At 12 and 24 months, consultations and acts realized by health professionals specialized (one hospital day care) | Other | Interventional |
| "As usual " patient care managementConventional management of heart failure patients is defined in the guide HAS ("Haute Autorité de Santé") care course. Patient follow-up, however, is defined by the patient's physician and / or cardiologist at the waning of his hospitalization, according to the usual practice for patients with stage II, III or IV NYHA. According to these recommendations, the patient should see his cardiologist at least once a year. Usual practices are: * An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency * At 12 months, a cardiologic consultation. For the study, three evaluation points are programmed: two by phone at 6 and 18 months, two by a consultation at 24 months. This interview aimed to evaluate the number of hospitalization, consultations and acts realized by health professionals specialized (the information in the logbook). | Other | Control |
Primary outcome
Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.
Time frame: 12 months
4 secondary outcomes
Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.
Time frame: At 6, 18 and 24 months
Quality of life.
Time frame: 12 months
Satisfaction.
Time frame: 3 months
Cost of medical care
Time frame: 24 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 14 Feb 2018.
- 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 PRETICARD patient care management and "As usual " patient care management in people with Severe 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 4 inclusion and 9 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 14 Feb 2018. 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?
Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure. (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 14 Feb 2018.