Early Care After Discharge of HF Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: 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; Other: Consultation with the general doctor or the cardiologist to J30 with blood results

• Registration Number: NCT01820780
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-03-28
• Study First Posted: 2013-03-29
• Study Start: 2013-06-10
• Primary Completion: 2019-03-27
• Study Completion: 2019-06-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 507

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intensive disease management	Natriuretic peptides levels to J7 and J14	Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
intensive disease management	Consultation with the general doctor or the cardiologist to J30 with blood results	Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
usual disease management	Phone calls in 6 months and 12 months	usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
usual disease management	Natriuretic peptides levels at 6 months	usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
intensive disease management	Natriuretic peptides levels at 6 months	Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
intensive disease management	Consultations specialized to J7 and J14	Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
intensive disease management	Phone calls in 6 months and 12 months	Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
usual disease management	Consultation with the general doctor or the cardiologist to J30 with blood results	usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.

Primary Outcome Measures

Name	Time	Method
Number of participants with all cause death or unplanned hospitalization at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Natriuretic peptides blood levels at 6 months.	6 months.
All cause mortality at 12 months	one year
Global cost of patient management	from day0 to 12 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
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
Unplanned HF-related hospitalization at 6 and 12 months	6 and 12 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
HF-treatment at 6 months	6 months
Mean and distribution NYHA classe at 6 months	6 months

Trial Locations

Locations (1)

Service de Cardiologie - Hopital Lariboisière; 🇫🇷 Paris, France