Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

Acute Heart Failure Clinical Trial

— CHIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834833
• Other study ID #: P110601 - PHRQ1104
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: July 2017

Study information

• Verified date: October 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Other:
• Follow-up
Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

Locations

Country	Name	City	State
France	Hopital Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days alive out of hospital 6 months post discharge		6 months
Secondary	rehospitalisation rate at 6 months		6 months
Secondary	mortality at 3 and 6 months		3 and 6 months
Secondary	number of patients receiving beta-blocker at 6 months		6 months
Secondary	number of patients receiving a ACEI at 6 months		6 months
Secondary	QOL at 6 months		6 months
Secondary	autoevaluation of improvement/alteration of the patient state at 6 months		6 months
Secondary	number of patients receiving beta-blocker at 3 months		3 months
Secondary	number of patients receiving a ACEI at 3 months		3 months
Secondary	QOL at 3 months		3 months
Secondary	autoevaluation of improvement/alteration of the patient state at 3 months		3 months
Secondary	number of patients having an optimal treatment at 6 months		6 months
Secondary	number of patients having an optimal treatment at 3 months		3 months