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Completed

NCT Number: NCT02763670

Patient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France.

The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.

The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.

This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.

The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.

The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.

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Key information

Conditions

Severe Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic heart failure patient with left ventricular ejection fraction (LVEF) defined by an impaired LVEF less than or equal to 40%.
  • Heart failure stage III or IV NYHA, or heart failure patients with stage II NYHA with previous hospitalization for heart failure.
  • Patient who has received a written or oral information of the study
  • Patient affiliated with French health Insurance

Exclusion criteria

  • Patient refusal to participate in the study
  • Progressive neoplastic pathology.
  • Patient with impaired cognitive functions known.
  • Patient subject to a measure of socio-legal protection.
  • Heart failure secondary to curable causes (an arrhythmia, valvular dysfunction, myocardial infarction, bypass surgery scheduled, aortic stenosis, breaking rope…)
  • Dyspnea pulmonary origin: pulmonary arterial hypertension pre-capillary origin catheterization, defined by a Pcap ≤15 mmHg.
  • Patient who underwent ventricular mechanical assistance.
  • Patient with acute breathlessness is explained by: a severe lung infection (CPT <60% of predicted, ventricular ejection fraction <60% predicted) or pulmonary embolism or respiratory failure with ambient air PaO2 (arterial oxygen pressure) below 60 mmHg or oxygen therapy.
  • Dialysis patient

Treatment and study plan

PRETICARD patient care management

Other

A standardized and specialized network to take care of the severe cardiac insufficiency:

  • An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
  • At 1 months, consultations and acts realized by health professionals specialized (one hospital day care)
  • At 2 months, a therapeutic education program for heart failure patients, approved by the Rhône-Alpes regional public health authorities (week hospital: two days and one night).
  • At 6 and 18 months, one cardiology consultation
  • At 12 and 24 months, consultations and acts realized by health professionals specialized (one hospital day care)

"As usual " patient care management

Other

Conventional management of heart failure patients is defined in the guide HAS ("Haute Autorité de Santé") care course. Patient follow-up, however, is defined by the patient's physician and / or cardiologist at the waning of his hospitalization, according to the usual practice for patients with stage II, III or IV NYHA.

According to these recommendations, the patient should see his cardiologist at least once a year.

Usual practices are:

  • An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
  • At 12 months, a cardiologic consultation. For the study, three evaluation points are programmed: two by phone at 6 and 18 months, two by a consultation at 24 months. This interview aimed to evaluate the number of hospitalization, consultations and acts realized by health professionals specialized (the information in the logbook).

Primary outcomes

  1. Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.

    Time frame: 12 months

Secondary outcomes

  1. Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.

    Time frame: At 6, 18 and 24 months

  2. Quality of life.

    Time frame: 12 months

    MINNESOTA Questionnaire.

  3. Satisfaction.

    Time frame: 3 months

    Semi-structured interviews.

  4. Cost of medical care

    Time frame: 24 months

    Identification of expenditure:

    • Hospitalizations
    • Consultations (inpatient and outpatient)
    • Biology and imaging
    • Medical transport

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.

Acronym: EFFICARD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 5, 2016
Registry last updated
Feb 14, 2018

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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