Clinical trial NCT02763670: Patient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France.
Official title: Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Heart Failure
Keywords: Heart failure
patient education as topic
patient care management
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.
timeFrame: At 6, 18 and 24 months
measure: Quality of life.
timeFrame: 12 months
measure: Satisfaction.
timeFrame: 3 months
measure: Cost of medical care
timeFrame: 24 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References: