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

NCT04653883 | Completed

• 1 other identifier: RECHMPL20_0307
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Sleep Disorder; Insomnia

Outcome Measures

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

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

  1 day

Secondary Outcomes (3)

• Evaluate the occurrence of fatal 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

  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

  1 day

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in this study are the patients followed in the Cardiology Department of the Montpellier University Hospital and diagnosed with heart failure according to the 2016 criteria of the European Society of Cardiology.

You may qualify if:

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

You may not qualify if:

• \- age less than 30 years

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Heart Failure; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• François BUGHIN, PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: December 4, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)