Early Care After Discharge of HF Patients

NCT ID: NCT01820780

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-10

Study Completion Date

2019-06-11

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intensive disease management

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

Group Type EXPERIMENTAL

Natriuretic peptides levels to J7 and J14

Intervention Type OTHER

Consultations specialized to J7 and J14

Intervention Type OTHER

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 months

Intervention Type OTHER

Natriuretic peptides levels at 6 months

Intervention Type OTHER

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

Intervention Type OTHER

usual disease management

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

Group Type ACTIVE_COMPARATOR

Phone calls in 6 months and 12 months

Intervention Type OTHER

Natriuretic peptides levels at 6 months

Intervention Type OTHER

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

Intervention Type OTHER

Interventions

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Natriuretic peptides levels to J7 and J14

Intervention Type OTHER

Consultations specialized to J7 and J14

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

Intervention Type OTHER

Phone calls in 6 months and 12 months

Intervention Type OTHER

Natriuretic peptides levels at 6 months

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LOGEART Damien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lariboisiere Hospital, APHP

Locations

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Service de Cardiologie - Hopital Lariboisière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P110128

Identifier Type: -

Identifier Source: org_study_id

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