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

Heart Failure Clinical Trial

— Pro-TSIC  

Official title:

Prognostic Impact of Sleep Disorders in Patients With Heart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653883
• Other study ID #: RECHMPL20_0307
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• age less than 30 years

Related Conditions & MeSH terms

• Heart Failure
• Insomnia
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders	Evaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders	1 day
Secondary	Evaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders	Evaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders	1 day
Secondary	Evaluate the occurrence of fatal or non-fatal major adverse cardiovascular events depending on whether or not medication is taken for sleep disorders	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