Early Care After Discharge of HF Patients (ECAD-HF)

Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.

After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome.

This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Natriuretic peptides levels to J7 and J14; Other: Consultations specialized to J7 and J14; Other: Phone calls in 6 months and 12 months; Other: Natriuretic peptides levels at 6 months; Other: Consultation with the general doctor or the cardiologist to J30 with blood results

Detailed Description

At discharge, high-risk HF patients are selected and randomized in two groups:

• Control group: usual disease management according to guidelines and including first medical consultation and biological test within the 4-week time following discharge.
• Active group: consultations with HF specialist including biological test at weeks 1, 2 and 4 are planned in addition to usual management.

• Study Type: Interventional
• Enrollment (Actual): 507
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Service de Cardiologie - Hôpital Lariboisière

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

Inclusion Criteria:

• 18 years or more
• consent signed

• Acute or decompensated heart failure with one or more of following criteria::

  • Discharge BNP > 350 pg/ml or NTproBNP > 2200 pg/ml
  • Discharge serum creatinine ≥ 180µM
  • Discharge systolic blood pressure ≤ 110mmHg
  • Previous hospitalisation for acute heart failure < 6 months

Exclusion Criteria:

• acute coronary syndrome,
• acute myocarditis,
• isolated right HF,
• transient HF,
• planned cardiac surgery,
• high risk of short-term non-cardiac death,
• planned management within rehabilitation center/HF clinic at discharge

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intensive disease management; Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.	Other: Natriuretic peptides levels to J7 and J14; Other: Consultations specialized to J7 and J14; Optimization of treatments Education on the signs of alert of the disease and on the medicines Reduction of the rate of BNP or NTproBNP = 30 % between the exit of the hospitalization and the second consultation Planning of an adapted coverage; Other: Phone calls in 6 months and 12 months; Other: Natriuretic peptides levels at 6 months; Other: Consultation with the general doctor or the cardiologist to J30 with blood results
Active Comparator: usual disease management; usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.	Other: Phone calls in 6 months and 12 months; Other: Natriuretic peptides levels at 6 months; Other: Consultation with the general doctor or the cardiologist to J30 with blood results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with all cause death or unplanned hospitalization at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
All cause mortality at 12 months	one year
Unplanned HF-related hospitalization at 6 and 12 months	6 and 12 months
Number of alive and hospitalization-free days at 6 and 12 months	6 and 12 months
Mean and distribution modified Goldman classe at 6 months	6 months
Natriuretic peptides blood levels at 6 months.	6 months.
Global cost of patient management	from day0 to 12 months
HF-treatment at 6 months	6 months
Mean and distribution NYHA classe at 6 months	6 months
Analysis of subgroups (LVEF altered or not, first HF episode or not, age> or ≤ 75, Changes in levels of BNP or NT-proBNP between day0 and the second consultation in the active group: ≥ 30% decrease, ≥ 30% increase, Intermediate variation).	6 months
Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: LOGEART Damien, MD, PhD, Lariboisière Hospital, APHP

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2013
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): June 11, 2019

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: March 28, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure; Disease management program
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P110128