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

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

— SYNCHRO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02870647
• Other study ID #: ICSY03
• Status: Withdrawn
• Phase: Phase 4
• First received: July 15, 2016
• Last updated: November 10, 2017
• Est. completion date: March 2020

Study information

• Verified date: November 2017
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Niguarda Ca Granda	Milano
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	CHU de Vigo	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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