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

Primary Purpose

Acute Heart Failure

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Follow-up

About this trial

This is an interventional supportive care trial for Acute Heart Failure focused on measuring Acute heart failure; rehospitalisation; education; follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hopital Bichat Claude Bernard

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Follow-up

Arm Description

usual care without systematic cardiology evaluation between 1 and 2 weeks

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

Outcomes

Primary Outcome Measures

days alive out of hospital 6 months post discharge

Secondary Outcome Measures

rehospitalisation rate at 6 months

mortality at 3 and 6 months

number of patients receiving beta-blocker at 6 months

number of patients receiving a ACEI at 6 months

QOL at 6 months

autoevaluation of improvement/alteration of the patient state at 6 months

number of patients receiving beta-blocker at 3 months

number of patients receiving a ACEI at 3 months

QOL at 3 months

autoevaluation of improvement/alteration of the patient state at 3 months

number of patients having an optimal treatment at 6 months

number of patients having an optimal treatment at 3 months

Full Information

NCT ID

NCT01834833

First Posted

January 17, 2013

Last Updated

October 22, 2018

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01834833

Brief Title

Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

Acronym

CHIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 2013 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

Keywords

Acute heart failure; rehospitalisation; education; follow-up

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

326 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

usual care without systematic cardiology evaluation between 1 and 2 weeks

Arm Title

Follow-up

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Follow-up

Intervention Description

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

Primary Outcome Measure Information:

Title

days alive out of hospital 6 months post discharge

Time Frame

6 months

Secondary Outcome Measure Information:

Title

rehospitalisation rate at 6 months

Time Frame

6 months

Title

mortality at 3 and 6 months

Time Frame

3 and 6 months

Title

number of patients receiving beta-blocker at 6 months

Time Frame

6 months

Title

number of patients receiving a ACEI at 6 months

Time Frame

6 months

Title

QOL at 6 months

Time Frame

6 months

Title

autoevaluation of improvement/alteration of the patient state at 6 months

Time Frame

6 months

Title

number of patients receiving beta-blocker at 3 months

Time Frame

3 months

Title

number of patients receiving a ACEI at 3 months

Time Frame

3 months

Title

QOL at 3 months

Time Frame

3 months

Title

autoevaluation of improvement/alteration of the patient state at 3 months

Time Frame

3 months

Title

number of patients having an optimal treatment at 6 months

Time Frame

6 months

Title

number of patients having an optimal treatment at 3 months

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillaume JONDEAU, MD, PHD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Bichat Claude Bernard

City

Paris

ZIP/Postal Code

75018

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

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