Completed

ECAD-HFSpecialized Follow-up for High-Risk Heart Failure Patients After Hospitalization

Study Aim

This study aims to provide specialized follow-up treatment for high-risk heart failure patients after hospitalization, with the primary goal of reducing the number of participants experiencing all cause death or unplanned hospitalization within 6 months.

What is being tested

Natriuretic peptides levels to J7 and J14

+ Consultations specialized to J7 and J14

+ Phone calls in 6 months and 12 months

Other

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2013

See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris

Last updated: September 23, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2013

Actual date on which the first participant was enrolled.

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.

NCT01820780

Principal SponsorAssistance Publique - Hôpitaux de Paris

Last updated: September 23, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

507 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Service de Cardiologie - Hopital Lariboisière

Paris, FranceOpen Service de Cardiologie - Hopital Lariboisière in Google Maps

CompletedOne Study Center