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Prognostic Impact of Sleep Disorders in Patients : Pro-TSIC Study

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04653883
Collaborator
(none)
115
Enrollment
1
Location
6
Actual Duration (Months)
19.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heart failure (HF) is a common and progressive condition associated with significant morbidity and mortality. Only 25-35% of patients survive 5 years after diagnosis.Sleep disorders are frequently found in this population with up to 94% of patients complaining of sleep disorders. Of these, insomnia and sleep disorders are the most common. The frequency of restless legs syndrome (RLS) varies between 4 and 40% depending on the studies. Patients with HF frequently experience poor sleep quality which is associated with deterioration in quality of life, alertness, and mood.

Few studies have examined the prognostic impact of sleep disturbances in this population. A greater morbidity and mortality is observed in the event of poor quality sleep or in the presence of sleep breathing disorders .

The investigators therefore propose to evaluate the sleep disorders of patients with HF by self-administered questionnaires, hypothesizing that complaints of poor sleep are linked to a poorer cardiovascular prognosis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    115 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prognostic Impact of Sleep Disorders in Patients With Heart
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    Sep 30, 2020
    Actual Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. To study the occurrence of cardiovascular events, whether fatal or not, according to the presence or absence of sleep or wakefulness disorders [1 day]

      composite endpoint including mortality from any cause, hospitalization forrom any cardiovascular eventscause, heart transplantation and implantation of a defibrillator or circulatory assistance

    Secondary Outcome Measures

    1. Evaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders [1 day]

      Evaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders

    2. Evaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders [1 day]

      Evaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders

    3. Evaluate the occurrence of fatal or non-fatal major adverse cardiovascular events depending on whether or not medication is taken for sleep disorders [1 day]

      Evaluate the occurrence of fatal or non-fatal major adverse cardiovascular events depending on whether or not medication is taken for sleep disorders

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • heart failure according to the 2016 criteria of the European Society of Cardiology.
    Exclusion criteria:
    • age less than 30 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: François BUGHIN, PH, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04653883
    Other Study ID Numbers:
    • RECHMPL20_0307
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Parasomnias

    Study Results

    No Results Posted as of Dec 29, 2020