Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

NCT ID: NCT01834833

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-07-31

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)

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

usual care without systematic cardiology evaluation between 1 and 2 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Follow-up

Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

Group Type: EXPERIMENTAL

Follow-up

Intervention Type: OTHER

Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

Interventions

Follow-up

Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume JONDEAU, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Bichat Claude Bernard

Paris, , France

Countries

France

Other Identifiers

P110601 - PHRQ1104

Identifier Type: -

Identifier Source: org_study_id