Early Care After Discharge of HF Patients

N/ACompletedNCT01820780

Assistance Publique - Hôpitaux de Paris507 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

507

Conditions

Heart Failure

Interventions

Natriuretic peptides levels to J7 and J14OTHER

Consultations specialized to J7 and J14OTHER

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

Phone calls in 6 months and 12 monthsOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Cardiologie - Hopital Lariboisière

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

All cause mortality at 12 months

Time frame: one year

Unplanned HF-related hospitalization at 6 and 12 months

Time frame: 6 and 12 months

Number of alive and hospitalization-free days at 6 and 12 months

Time frame: 6 and 12 months

Mean and distribution modified Goldman classe at 6 months

Time frame: 6 months

Natriuretic peptides blood levels at 6 months.

Time frame: 6 months.

Global cost of patient management

Time frame: from day0 to 12 months

HF-treatment at 6 months

Time frame: 6 months

Mean and distribution NYHA classe at 6 months

Time frame: 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).

Time frame: 6 months

Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months

Data from ClinicalTrials.gov

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