NCT01820780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2019

Completed
Last Updated

September 23, 2021

Status Verified

February 1, 2021

Enrollment Period

5.8 years

First QC Date

January 25, 2013

Last Update Submit

September 22, 2021

Conditions

Heart Failure

Keywords

Heart failureDisease management program

Outcome Measures

Primary Outcomes (1)

  • Number of participants with all cause death or unplanned hospitalization at 6 months

    6 months

Secondary Outcomes (10)

  • All cause mortality at 12 months

    one year

  • Unplanned HF-related hospitalization at 6 and 12 months

    6 and 12 months

  • Number of alive and hospitalization-free days at 6 and 12 months

    6 and 12 months

  • Mean and distribution modified Goldman classe at 6 months

    6 months

  • Natriuretic peptides blood levels at 6 months.

    6 months.

  • +5 more secondary outcomes

Study Arms (2)

intensive disease management

EXPERIMENTAL

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 J14Other: Consultations specialized to J7 and J14Other: 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 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.

Other: 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 results

Interventions

Natriuretic peptides levels to J7 and J14OTHER
intensive disease management
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

intensive disease management
Phone calls in 6 months and 12 monthsOTHER
intensive disease managementusual disease management
Natriuretic peptides levels at 6 monthsOTHER
intensive disease managementusual disease management
Consultation with the general doctor or the cardiologist to J30 with blood resultsOTHER
intensive disease managementusual disease management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Cardiologie - Hopital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • LOGEART Damien, MD, PhD

    Lariboisiere Hospital, APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

March 29, 2013

Study Start

June 10, 2013

Primary Completion

March 27, 2019

Study Completion

June 11, 2019

Last Updated

September 23, 2021

Record last verified: 2021-02

Locations

FR(1)