Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient (CHIC)

Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.

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

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure
• Intervention / Treatment: Other: Follow-up

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)

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Hôpital Bichat Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; usual care without systematic cardiology evaluation between 1 and 2 weeks
Experimental: Follow-up; Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary	Other: Follow-up; Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
days alive out of hospital 6 months post discharge	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
rehospitalisation rate at 6 months	6 months
mortality at 3 and 6 months	3 and 6 months
number of patients receiving beta-blocker at 6 months	6 months
number of patients receiving a ACEI at 6 months	6 months
QOL at 6 months	6 months
autoevaluation of improvement/alteration of the patient state at 6 months	6 months
number of patients receiving beta-blocker at 3 months	3 months
number of patients receiving a ACEI at 3 months	3 months
QOL at 3 months	3 months
autoevaluation of improvement/alteration of the patient state at 3 months	3 months
number of patients having an optimal treatment at 6 months	6 months
number of patients having an optimal treatment at 3 months	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Guillaume JONDEAU, MD, PHD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Acute heart failure; rehospitalisation; education; follow-up
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P110601 - PHRQ1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided