Heart FailureECAD-HFNCT01820780
Early Care After Discharge of HF Patients
A study testing Natriuretic peptides levels to J7 and J14, Consultations specialized to J7 and J14 and Phone calls in 6 months and 12 months in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Natriuretic peptides levels to J7 and J14, Consultations specialized to J7 and J14 and Phone calls in 6 months and 12 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2013to 11 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- 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
- Keywords
- Heart failure, Disease management program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Natriuretic peptides levels at 6 monthsOther
Consultation with the general doctor or the cardiologist to J30 with blood resultsOther
| Study group | Role | What they receive |
|---|---|---|
| intensive disease management | Experimental | Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care. Receives: Other: Natriuretic peptides levels to J7 and J14; Other: Consultations specialized to J7 and J14; Other: Phone calls in 6 months and 12 months; Other: Natriuretic peptides levels at 6 months; Other: Consultation with the general doctor or the cardiologist to J30 with blood results |
| usual disease management | Active comparator | usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge. Receives: Other: Phone calls in 6 months and 12 months; Other: Natriuretic peptides levels at 6 months; Other: Consultation with the general doctor or the cardiologist to J30 with blood results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with all cause death or unplanned hospitalization at 6 months
Measured: 6 months
Secondary outcomes (10)
All cause mortality at 12 months
Measured: one year
Unplanned HF-related hospitalization at 6 and 12 months
Measured: 6 and 12 months
Number of alive and hospitalization-free days at 6 and 12 months
Measured: 6 and 12 months
Mean and distribution modified Goldman classe at 6 months
Measured: 6 months
Natriuretic peptides blood levels at 6 months.
Measured: 6 months.
Global cost of patient management
Measured: from day0 to 12 months
HF-treatment at 6 months
Measured: 6 months
Mean and distribution NYHA classe at 6 months
Measured: 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).
Measured: 6 months
Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study start10 Jun 2013
- Primary completion27 Mar 2019
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOGEART Damien, MD, PhD, Principal investigator, Lariboisiere Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820780
- Sponsor's protocol ID
- P110128
- Acronym
- ECAD-HF
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2013
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01820780
- Acronym / sponsor ID
- ECAD-HF / P110128
- Conditions
- Heart Failure
- Keywords
- Heart failure, Disease management program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jun 2013 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive disease management | Experimental | Other: Natriuretic peptides levels to J7 and J14, Other: Consultations specialized to J7 and J14, Other: Phone calls in 6 months and 12 months, Other: Natriuretic peptides levels at 6 months, Other: Consultation with the general doctor or the cardiologist to J30 with blood resultsPlanned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care. |
| usual disease management | Active comparator | Other: Phone calls in 6 months and 12 months, Other: Natriuretic peptides levels at 6 months, Other: Consultation with the general doctor or the cardiologist to J30 with blood resultsusual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or more
- consent signed
- Acute or decompensated heart failure with one or more of following criteria::
Key exclusion criteria (7 listed)
- acute coronary syndrome,
- acute myocarditis,
- isolated right HF,
- transient HF,
- planned cardiac surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natriuretic peptides levels to J7 and J14 | Other | intensive disease management |
| Consultations specialized to J7 and J14Optimization 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 | Other | intensive disease management |
| Phone calls in 6 months and 12 months | Other | intensive disease management, usual disease management |
| Natriuretic peptides levels at 6 months | Other | intensive disease management, usual disease management |
| Consultation with the general doctor or the cardiologist to J30 with blood results | Other | intensive disease management, usual disease management |
Primary outcome
Number of participants with all cause death or unplanned hospitalization at 6 months
Time frame: 6 months
10 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
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LOGEART Damien, MD, PhD principal investigator
Lariboisiere Hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natriuretic peptides levels to J7 and J14, Consultations specialized to J7 and J14 and Phone calls in 6 months and 12 months in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with all cause death or unplanned hospitalization at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.