Adaptive Servo Ventilation (ASV) in Heart Failure

July 25, 2018 updated by: Mark Ledwidge, St Vincent's University Hospital, Ireland

Adaptive Servo Ventilation (ASV) in the Management of Acute Decompensated Heart Failure (ADHF)

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Sleep disordered breathing (SDB) is common in patients with heart failure (HF) and is an independent predictor of morbidity and mortality. Adaptive servo-ventilation (ASV) is reported as the most effective treatment for SDB in HF and has been shown to improve cardiac function in patients with HF coexistent with SDB. ASV may also be an effective therapeutic option for patients with HF regardless of presence or severity of SDB.

The aim of the study is to investigate the potential role for ASV in improving the management of ADHF in the acute hospital phase and reducing complications in the vulnerable post discharge period. This is an observational study of forty patients admitted to hospital with ADHF.

In this clinical investigation, the ApneaLinkTM Plus device will measure patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The research participant will be connected to the device during their inpatient hospitalisation as soon as they are stabilised off oxygen. These recordings will aid the diagnosis of SDB for further clinical investigation.

The S9 Autoset CS-A system will be evaluated to determine whether ASV has beneficial effects on the cardiac function of patients with ADHF. During an in-patient run-in phase, the patients tolerability to ASV therapy will be assessed and if tolerated well, the patient will continue with this therapy following discharge for 45 days.

The SleepMinder sensor device will monitor the sleep and breathing patterns of the participants as they sleep, and in doing so, sleep apnoeas will be detected. Each patient will monitor their weight daily using a Precision Personal Health Scales for 90 days. Finally, a questionnaire will be completed by the patient which allows them to self-report their HF symptoms.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 4
        • St Vincents University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of inpatient HF hospitalisation
Time Frame: Patients are followed during the inpatient admission, currently an average of 14 days
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)
Time Frame: Patients are followed during the inpatient admission and an approximate time to clinical stability is determined, currently less than an average of 14 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to event using a combined morbidity index
Time Frame: From baseline to study end, an average of approximately 12 months
Time to event using a combined morbidity index including re-hospitalisation (all-cause, cardiac, HF), outpatient attendance with intravenous diuretics, outpatient attendance with symptomatic deteriorations requiring adjustment of oral diuretic, home/patient adjustment of oral diuretic treatment without patient outpatient clinic attendance.
From baseline to study end, an average of approximately 12 months
Natriuretic peptide (NTproBNP) levels
Time Frame: Baseline, 45 days and 90 days
Baseline, 45 days and 90 days
B-Type Natriuretic peptide (BNP) levels
Time Frame: Baseline, 45 days and 90 days
Baseline, 45 days and 90 days
Ejection fraction
Time Frame: Baseline, 45 days and 90 days
Baseline, 45 days and 90 days
Creatinine clearance
Time Frame: Baseline, 45 days and 90 days
Baseline, 45 days and 90 days
Markers of renal damage
Time Frame: Baseline, 45 days and 90 days
Kidney injury molecule-1(KIM-1)
Baseline, 45 days and 90 days
Markers of renal damage
Time Frame: Baseline, 45 days and 90 days
Neutrophil gelatinase-associated lipocalin (NGAL)
Baseline, 45 days and 90 days
Markers of matrix turnover
Time Frame: Baseline, 45 days and 90 days
Matrix metalloproteinase (MMP)-2 and -9
Baseline, 45 days and 90 days
Markers of inflammation
Time Frame: Baseline, 45 days and 90 days
hsCRP
Baseline, 45 days and 90 days
Comparative Sleep Disordered Breathing
Time Frame: Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Measured by the ApneaLinkTM Plus
Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Comparative Sleep Disordered Breathing
Time Frame: Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Measured by SleepMinder
Baseline, 45 days, 90 days and study end, an average of approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Vincent's University Hospital, Ireland

Collaborators

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFU-CM-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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