Back to resultsSleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients (SYNCHRO)
Primary Purpose
Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
Eligibility Criteria
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
Sites / Locations
- Ospedale Niguarda Ca Granda
- Hospital Clinic de Barcelona
- CHU de Vigo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm study
Arm Description
only 1 arm - no comparison nor randomization in this study
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02870647
Brief Title
Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Acronym
SYNCHRO
Official Title
Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Strategy changes.
Study Start Date
undefined (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm study
Arm Type
Other
Arm Description
only 1 arm - no comparison nor randomization in this study
Intervention Type
Other
Intervention Name(s)
Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
Intervention Description
each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months
Primary Outcome Measure Information:
Title
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ospedale Niguarda Ca Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
CHU de Vigo
City
Vigo
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
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