Back to resultsEarly Care After Discharge of HF Patients (ECAD-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Natriuretic peptides levels to J7 and J14
Consultations specialized to J7 and J14
Phone calls in 6 months and 12 months
Natriuretic peptides levels at 6 months
Consultation with the general doctor or the cardiologist to J30 with blood results
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Disease management program
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
Sites / Locations
- Service de Cardiologie - Hopital Lariboisière
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intensive disease management
usual disease management
Arm Description
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
Outcomes
Primary Outcome Measures
Number of participants with all cause death or unplanned hospitalization at 6 months
Secondary Outcome Measures
All cause mortality at 12 months
Unplanned HF-related hospitalization at 6 and 12 months
Number of alive and hospitalization-free days at 6 and 12 months
Mean and distribution modified Goldman classe at 6 months
Natriuretic peptides blood levels at 6 months.
Global cost of patient management
HF-treatment at 6 months
Mean and distribution NYHA classe at 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).
Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months
Full Information
NCT ID
NCT01820780
First Posted
January 25, 2013
Last Updated
September 22, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01820780
Brief Title
Early Care After Discharge of HF Patients
Acronym
ECAD-HF
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2013 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
June 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Disease management program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
507 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intensive disease management
Arm Type
Experimental
Arm Description
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
Arm Title
usual disease management
Arm Type
Active Comparator
Arm Description
usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
Intervention Type
Other
Intervention Name(s)
Natriuretic peptides levels to J7 and J14
Intervention Type
Other
Intervention Name(s)
Consultations specialized to J7 and J14
Intervention Description
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
Intervention Name(s)
Phone calls in 6 months and 12 months
Intervention Type
Other
Intervention Name(s)
Natriuretic peptides levels at 6 months
Intervention Type
Other
Intervention Name(s)
Consultation with the general doctor or the cardiologist to J30 with blood results
Primary Outcome Measure Information:
Title
Number of participants with all cause death or unplanned hospitalization at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
All cause mortality at 12 months
Time Frame
one year
Title
Unplanned HF-related hospitalization at 6 and 12 months
Time Frame
6 and 12 months
Title
Number of alive and hospitalization-free days at 6 and 12 months
Time Frame
6 and 12 months
Title
Mean and distribution modified Goldman classe at 6 months
Time Frame
6 months
Title
Natriuretic peptides blood levels at 6 months.
Time Frame
6 months.
Title
Global cost of patient management
Time Frame
from day0 to 12 months
Title
HF-treatment at 6 months
Time Frame
6 months
Title
Mean and distribution NYHA classe at 6 months
Time Frame
6 months
Title
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
Title
Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOGEART Damien, MD, PhD
Organizational Affiliation
Lariboisiere Hospital, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Cardiologie - Hopital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Early Care After Discharge of HF Patients
We'll reach out to this number within 24 hrs