None listed
Conditions
Brief summary
COPD and OSA are the most prevalent respiratory diseases. Patients with both conditions termed overlap syndrome are at increased risk of dying from cardiac related problems. Positive airway pressure therapy are devices that stabilise the airway and assist with breathing. The aims of this study is to assess whether positive airway pressure therapy can reverse the negative consequences that occur in the heart of people with overlap syndrome and whether it can reduce their cardiovascular risk.
Interventions
This is a 3 month, prospective observational study to assess the effect of positive airway pressure (PAP) therapy on cardiac remodeling as assessed by cardiac magnetic resonance imaging (CMRI). PAP therapy will consist of either continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) depending on the predominant feature of obstructive sleep apnoea (OSA) or chronic obstructive pulmonary disease (COPD) and the presence of hypercapnic respiratory failure and will be determined
This is a 3 month, prospective observational study to assess the effect of positive airway pressure (PAP) therapy on cardiac remodeling as assessed by cardiac magnetic resonance imaging (CMRI). PAP therapy will consist of either continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) depending on the predominant feature of obstructive sleep apnoea (OSA) or chronic obstructive pulmonary disease (COPD) and the presence of hypercapnic respiratory failure and will be determined by the patient’s treating physician rather than the study investigators. Patients selected for the study will have overlap syndrome (OVS) and meet clinical criteria for initiating PAP therapy but have not yet commenced treatment. PAP therapy will be determinted by the patient's usual treating physician and only patients who agree to commence PAP therapy will be eligible to participate in this study. Patients who cease PAP therapy after enrolling in the study may still be included for the final analysis if they agree to continue in the study. The secondary objective is to investigate whether PAP therapy also leads to improvement in other surrogate markers of cardiovascular (CV) risk, neurocognitive function, exercise capacity and quality of life scores. Participants deemed suitable for entry into the study will be contacted and undergo consent, randomization, and the following procedures at baseline and again after 3 months. - CMRI will be performed by a radiologist and interpreted by an accredited cardiologist. It should take approximately 60 minutes to complete. - Blood sampling for cardiac biomarkers (NT-pro-BNP, troponin, C-reactive peptide) will be performed by one of the study investigators and will take approximately 5 minutes - Pulse wave analysis (PWA) will be performed by one of the study investigators and should take 10-15 minutes. - Cognitive test battery will be performed by one of the study investigators and should take about 30 minutes - 6 minute walk testing (6MWT) will be performed by one of the study investigators and should take about 10 minutes - Quality of life (QoL) scores will be performed by one of the study investigators and should take about 30 minutes. - cardiopulmonary coupling (CPC) analysis and quantitative EEG analysis will be performed on data collected during sleep study. Patients will be treated for 3 months with PAP therapy, either CPAP or NIV. Their compliance and usage will be monitored remotely. Patients will also receive weekly phone calls to verify their compliance and ensure there are no issues with their PAP therapy or equipment. End of 3 months: Repeat cardiac MRI, blood sampling for cardiac biomarkers (NT-pro-BNP, troponin, CRP, metabolic markers), PWA, cognitive test battery, 6MWT and QoL scores. CPC and quantitative EEG analysis will be performed on data collected during sleep study.
Sponsors
The University of Sydney
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Participants must be aged 40 years old or older. • At least 10 pack-year smoking history. • Spirometry demonstrating post bronchodilator FEV1/FVC less than the lower limits of normal (LLN) and FEV1 less than the LLN. • Polysomnography (PSG) or level 2 home sleep study performed within the last 6 months of first medical visit demonstrating apnoea hypopnoea index (AHI) of equal to or greater than 30. • Patient is not already on PAP therapy and the treating physician deems patient should start PAP therapy.
Exclusion criteria
• Unstable patients (COPD exacerbation within last 4 weeks or myocardial infarction or stroke within the last 6 weeks) • Neuromuscular disease. • Sleep disorders other than OSA. • Patients who have a contraindication to or don’t tolerate CMRI or PAP therapy. • Moderate or greater valvular heart disease. • Renal insufficiency with eGFR<30 ml/min/1.73m2 • Unstable Malignancy. • History of major psychiatric disorder in the last 12 months which is likely to affect adherence to trial protocol and follow up • Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Outcome results
None listed