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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Heart Failure

Treatments: Other: Consultation with the general doctor or the cardiologist to J30 with blood results; Other: Natriuretic peptides levels to J7 and J14; Other: Phone calls in 6 months and 12 months; Other: Natriuretic peptides levels at 6 months; Other: Consultations specialized to J7 and J14

Study type: Interventional

Funder types: Other

Identifiers

NCT01820780

P110128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 507 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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507 participants in 2 patient groups

intensive disease management

Experimental group

Description:

Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.

Treatment:

Other: Phone calls in 6 months and 12 months

Other: Consultations specialized to J7 and J14

Other: Consultation with the general doctor or the cardiologist to J30 with blood results

Other: Natriuretic peptides levels at 6 months

Other: Natriuretic peptides levels to J7 and J14

usual disease management

Active Comparator group

Description:

usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.

Treatment:

Other: Phone calls in 6 months and 12 months

Other: Consultation with the general doctor or the cardiologist to J30 with blood results

Other: Natriuretic peptides levels at 6 months