Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 507
- Locations
- 1
- Primary Endpoint
- Number of participants with all cause death or unplanned hospitalization at 6 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
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(one year)
- Natriuretic peptides blood levels at 6 months.(6 months.)
- 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)