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Completed

NCT Number: NCT04653883

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Dyssomnias Heart Diseases Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • heart failure according to the 2016 criteria of the European Society of Cardiology.

Exclusion criteria

  • age less than 30 years

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Prognostic Impact of Sleep Disorders in Patients With Heart

Acronym: Pro-TSIC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Dec 29, 2020

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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