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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St Vincent's University Hospital, Ireland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Acute Decompensated Heart Failure

Clinical Trials on S9-Autoset CS-A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings