Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

NCT01834833 | Completed

• 1 other identifier: P110601 - PHRQ1104
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Heart Failure

Keywords

Acute heart failure; rehospitalisation; education; follow-up

Outcome Measures

Primary Outcomes (1)

• days alive out of hospital 6 months post discharge

  6 months

Secondary Outcomes (12)

• 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

Study Arms (2)

Control

NO INTERVENTION

usual care without systematic cardiology evaluation between 1 and 2 weeks

Follow-up

EXPERIMENTAL

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

Other: Follow-up

Interventions

Follow-up OTHER

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

Follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat Claude Bernard

Paris, 75018, France

Location

Study Officials

• Guillaume JONDEAU, MD, PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: April 18, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

FR (1)