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

Phase 4

Withdrawn

• Conditions: Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
• Interventions: Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire

• Registration Number: NCT02870647
• Lead Sponsor: LivaNova

Brief 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.

Study Timeline

• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14
• Primary Completion: 2019-06
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient successfully* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
• Signed and dated informed consent
• The subject will be available for postoperative follow-up beyond one year

Exclusion Criteria

• Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
• Already included in another clinical study that could confound the results of this study
• Not available to attend routine follow-up visits
• Not able to understand the aim of the study and its procedures
• Minor age (according to local regulation)
• Drug / alcohol addiction or abuse
• Known pregnancy
• Under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire	only 1 arm - no comparison nor randomization in this study

Primary Outcome Measures

Name	Time	Method
The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).	6 months

Secondary Outcome Measures

Name	Time	Method
The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.	12 months

Trial Locations

Locations (3)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

CHU de Vigo; 🇪🇸 Vigo, Spain

Ospedale Niguarda Ca Granda; 🇮🇹 Milano, Italy