Clinical trial NCT01820780: Early Care After Discharge of HF Patients
Official title: Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Disease management program
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with all cause death or unplanned hospitalization at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: All cause mortality at 12 months
timeFrame: one year
measure: Unplanned HF-related hospitalization at 6 and 12 months
timeFrame: 6 and 12 months
measure: Number of alive and hospitalization-free days at 6 and 12 months
timeFrame: 6 and 12 months
measure: Mean and distribution modified Goldman classe at 6 months
timeFrame: 6 months
measure: Natriuretic peptides blood levels at 6 months.
timeFrame: 6 months.
measure: Global cost of patient management
timeFrame: from day0 to 12 months
measure: HF-treatment at 6 months
timeFrame: 6 months
measure: Mean and distribution NYHA classe at 6 months
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
measure: Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Cardiologie - Hopital Lariboisière
Study officials:
affiliation: Lariboisiere Hospital, APHP
name: LOGEART Damien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: