Clinical trial NCT01834833: Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient
Official title: Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
Keywords: Acute heart failure; rehospitalisation; education; follow-up
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months

Detailed description: Background: the risk for rehospitalisation is very high after hospitalisation for acute heart failure. Aim: evaluate the benefit of a consultation with a cardiologist, including echocardiography and education of the patient, between 7 and 15 days after discharge, in high risk patients, identified with BNP or incomplete therapy. Parallel randomised study. The main endpoint is the number of day alive out of hospital during the 6 months post discharge; statistics intention to treat comparison of the number of days alive out of hospital in the group with consultation compared with the group without consultation. Recruitment 3 years and 4 months, follow-up 6 months. Patients included have been hospitalised in hospital BICHAT 75018 Paris, France. Financing is by the ministry of health (PHRQHOS)

Eligibility criteria: Criteria of inclusion :

* Patient with decompensated heart failure hospitalized in the hospital BICHAT,
* For whom is planned a return at home,
* Valid (being able to return for a consultation to the hospital)
* Having Nt-ProBNP of exit ≥ 3500 ng /l and/or a non optimized treatment of exit - according to the doctor who has it the responsibility,
* Having signed the consent form by participation in the study.

Criteria of not inclusion :

* Age \< 18 years,
* Not membership in a national insurance scheme or in the Universal Health
* Coverage (CMU)(FREE UNIVERSAL HEALTH CARE)(A patient benefiting from the Medical aid of the State (AME) cannot be included)
* Participation to another protocol of research,
* Not being reachable by telephone in 6 months.

Primary outcomes:
measure: days alive out of hospital 6 months post discharge
timeFrame: 6 months
Secondary outcomes:
measure: rehospitalisation rate at 6 months
timeFrame: 6 months
measure: mortality at 3 and 6 months
timeFrame: 3 and 6 months
measure: number of patients receiving beta-blocker at 6 months
timeFrame: 6 months
measure: number of patients receiving a ACEI at 6 months
timeFrame: 6 months
measure: QOL at 6 months
timeFrame: 6 months
measure: autoevaluation of improvement/alteration of the patient state at 6 months
timeFrame: 6 months
measure: number of patients receiving beta-blocker at 3 months
timeFrame: 3 months
measure: number of patients receiving a ACEI at 3 months
timeFrame: 3 months
measure: QOL at 3 months
timeFrame: 3 months
measure: autoevaluation of improvement/alteration of the patient state at 3 months
timeFrame: 3 months
measure: number of patients having an optimal treatment at 6 months
timeFrame: 6 months
measure: number of patients having an optimal treatment at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guillaume JONDEAU, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: