NCT02870647

Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.

Detailed description

The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up. The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period. Predictors of the clinical outcomes will be investigated.

Conditions

• Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

Interventions

Type	Name	Description
OTHER	Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire	each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months

Timeline

• Primary completion: 2019-06-01
• Completion: 2020-03-01
• First posted: 2016-08-17
• Last updated: 2017-11-14

Locations

3 sites across 2 countries: Italy, Spain