Adaptive Servo Ventilation (ASV) in Heart Failure

NCT02440971 | Suspended

• 1 other identifier: HFU-CM-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and have important prognostic implications. SDB is however, treatable with the use of non invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The aim of the study is to observe and investigate the potential role of ASV in the management of heart failure. Patients that agree to participate in this study will be requested to use an ASV ventilator device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is approximately the size of a large shoe box, which can be placed at the side of the bed, with tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows positive air pressure as determined by the device itself as it constantly monitors the patients breathing throughout the night. During this study, the patients breathing patterns will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a SleepMinder will sit on the patients bedside locker as another form of monitoring of their sleep patterns. Study staff will monitor the patient and give them frequent support, and they will also be asked questions regarding their experiences with this equipment and any symptoms they may have over this time. They will be followed up regarding this study at the same time as their follow-up requirements for their heart failure. This study will be conducted in total over 3 months.

Conditions

Acute Decompensated Heart Failure; Sleep Disordered Breathing

Keywords

Adaptive Servo Ventilation; Acute decompensated heart failure; SleepMinder; ApneaLink Plus; Sleep disordered breathing; Natriuretic peptide

Outcome Measures

Primary Outcomes (2)

• Length of inpatient HF hospitalisation

  Admission to ready-for-discharge in days

  Patients are followed during the inpatient admission, currently an average of 14 days

• Time to clinical stability (days)

  Patients are followed during the inpatient admission and an approximate time to clinical stability is determined, currently less than an average of 14 days

Secondary Outcomes (11)

• Time to event using a combined morbidity index

  From baseline to study end, an average of approximately 12 months

• Natriuretic peptide (NTproBNP) levels

  Baseline, 45 days and 90 days

• B-Type Natriuretic peptide (BNP) levels

  Baseline, 45 days and 90 days

• Ejection fraction

  Baseline, 45 days and 90 days

• Creatinine clearance

  Baseline, 45 days and 90 days

Interventions

S9-Autoset CS-A DEVICE

The S9-Autoset CS-A is an adaptive servo-ventilation (ASV) machine. It adjusts the level of inspiratory support automatically in response to the patient's respiratory effort. Inspiratory support is increased in the presence of hypoventilation and decreased in the presence of hyperventilation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted into hospital for acute management of ADHF are eligible to participate in this study (providing inclusion/exclusion criteria are met)

You may qualify if:

• Admitted to the hospital with a primary diagnosis of ADHF
• Stable off oxygen for 24 hours
• Informed consent
• Age ≥ 18 years

You may not qualify if:

• Age \< 18 years
• Pregnant women, breastfeeding mothers
• Anyone not capable of giving informed consent
• Contraindications to positive airway pressure:
• Severe bullous lung disease
• Dehydration
• Cerebrospinal fluid leak
• Acute sinusitis or otitis media
• Epistaxis (severe nose bleeds) causing a risk of pulmonary aspiration
• Conditions predisposing to a risk of vomiting into mask
• Impaired ability to clear secretions
• Hypotension (defined as systolic BP \< 100mmHg) or significant intravascular volume depletion
• Pneumothorax or pneumomediastinum
• Recent cranial trauma or surgery.

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead
• ResMed: collaborator

Study Sites (1)

St Vincents University Hospital

Dublin, Dublin 4, Ireland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kenneth M McDonald, MD

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ken McDonald, Consultant Cardiologist, St Vincent's University Hospital, Ireland

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: May 12, 2015
• Study Start: May 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

IE (1)