ECAD-HF: Early Care After Discharge of HF Patients

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT01820780
• Collaborator: (none)
• Enrollment: 507
• Location: 1
• Arms: 2
• Actual Duration (Months): 72
• Patients Per Site Per Month: 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	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	N/A

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

• Study Type: Interventional
• Actual Enrollment: 507 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
• Actual Study Start Date: Jun 10, 2013
• Actual Primary Completion Date: Mar 27, 2019
• Actual Study Completion Date: Jun 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intensive disease management Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.	Other: Natriuretic peptides levels to J7 and J14; 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; 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
Active Comparator: usual disease management usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.	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

Outcome Measures

Primary Outcome Measures

1. Number of participants with all cause death or unplanned hospitalization at 6 months [6 months]

Secondary Outcome Measures

1. All cause mortality at 12 months [one year]

2. Unplanned HF-related hospitalization at 6 and 12 months [6 and 12 months]

3. Number of alive and hospitalization-free days at 6 and 12 months [6 and 12 months]

4. Mean and distribution modified Goldman classe at 6 months [6 months]

5. Natriuretic peptides blood levels at 6 months. [6 months.]

6. Global cost of patient management [from day0 to 12 months]

7. HF-treatment at 6 months [6 months]

8. Mean and distribution NYHA classe at 6 months [6 months]

9. 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]

10. Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Cardiologie - Hopital Lariboisière	Paris		France	75010

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: LOGEART Damien, MD, PhD, Lariboisiere Hospital, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01820780
• Other Study ID Numbers: P110128
• First Posted: Mar 29, 2013
• Last Update Posted: Sep 23, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Assistance Publique - Hôpitaux de Paris: Heart failure; Disease management program
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Sep 23, 2021