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Completed

NCT Number: NCT01820780

Early Care After Discharge of HF Patients

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Cardiologie - Hopital Lariboisière

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natriuretic peptides levels to J7 and J14

Other

Consultations specialized to J7 and J14

Other

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 months

Other

Natriuretic peptides levels at 6 months

Other

Consultation with the general doctor or the cardiologist to J30 with blood results

Other

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. All cause mortality at 12 months

    Time frame: one year

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

    Time frame: 6 and 12 months

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

    Time frame: 6 and 12 months

  4. Mean and distribution modified Goldman classe at 6 months

    Time frame: 6 months

  5. Natriuretic peptides blood levels at 6 months.

    Time frame: 6 months.

  6. Global cost of patient management

    Time frame: from day0 to 12 months

  7. HF-treatment at 6 months

    Time frame: 6 months

  8. Mean and distribution NYHA classe at 6 months

    Time frame: 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).

    Time frame: 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.

Acronym: ECAD-HF

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2013
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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