ClinicalTrials.gov
ClinicalTrials.gov Menu

Adaptive Servo Ventilation (ASV) in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02440971
Recruitment Status : Suspended
First Posted : May 12, 2015
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Mark Ledwidge, St Vincent's University Hospital, Ireland

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.


Condition or disease Intervention/treatment
Acute Decompensated Heart Failure Sleep Disordered Breathing Device: S9-Autoset CS-A

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
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptive Servo Ventilation (ASV) in the Management of Acute Decompensated Heart Failure (ADHF)
Study Start Date : May 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: S9-Autoset CS-A
    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.


Primary Outcome Measures :
  1. 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

  2. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. Natriuretic peptide (NTproBNP) levels [ Time Frame: Baseline, 45 days and 90 days ]
  3. B-Type Natriuretic peptide (BNP) levels [ Time Frame: Baseline, 45 days and 90 days ]
  4. Ejection fraction [ Time Frame: Baseline, 45 days and 90 days ]
  5. Creatinine clearance [ Time Frame: Baseline, 45 days and 90 days ]
  6. Markers of renal damage [ Time Frame: Baseline, 45 days and 90 days ]
    Kidney injury molecule-1(KIM-1)

  7. Markers of renal damage [ Time Frame: Baseline, 45 days and 90 days ]
    Neutrophil gelatinase-associated lipocalin (NGAL)

  8. Markers of matrix turnover [ Time Frame: Baseline, 45 days and 90 days ]
    Matrix metalloproteinase (MMP)-2 and -9

  9. Markers of inflammation [ Time Frame: Baseline, 45 days and 90 days ]
    hsCRP

  10. 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

  11. Comparative Sleep Disordered Breathing [ Time Frame: Baseline, 45 days, 90 days and study end, an average of approximately 12 months ]
    Measured by SleepMinder



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440971


Locations
Ireland
St Vincents University Hospital
Dublin, Ireland, Dublin 4
Sponsors and Collaborators
St Vincent's University Hospital, Ireland
ResMed
Investigators
Principal Investigator: Kenneth M McDonald, MD St Vincent's University Hospital

Responsible Party: Mark Ledwidge, Professor Ken McDonald, Consultant Cardiologist, St Vincent's University Hospital, Ireland, St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier: NCT02440971     History of Changes
Other Study ID Numbers: HFU-CM-001
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Keywords provided by Mark Ledwidge, St Vincent's University Hospital, Ireland:
Adaptive Servo Ventilation
Acute decompensated heart failure
SleepMinder
ApneaLink Plus
Sleep disordered breathing
Natriuretic peptide

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes