The Role of Cardiopulmonary Exercise Testing in People With Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum Oxygen Consumption at peak exercise (VO2peak)
研究概览
简要总结
Heart failure affects 1-2% of the adult population. Up to half of these patients have apparently normal heart pumping function, known as heart failure with preserved ejection fraction (HFpEF). Because HFpEF typically occurs in elderly patients with multiple comorbidities, many different mechanisms could drive symptoms and life expectancy, and it has been difficult to find effective treatments that work for all. Symptoms of HFpEF occur during exertion. The current scoring system for the diagnosis of HFpEF is not able to identify the majority of people and the majority of people remain in the zone of diagnostic uncertainty; there is no definite follow-up strategy, thus people do not receive appropriate treatment. Also, the medications, prehabilitation, and rehabilitation services are not personalised.
To cater to these gaps in clinical practice, this study was set up to use Cardiopulmonary exercise testing (CPET) to understand the complexity of this disease. The investigators plan to recruit patients with clinical suspicion of HFpEF, referred to the Cardiology Department at Ulster Hospital, Belfast, UK. After screening the medical records of patients based on the inclusion and exclusion criteria, the investigators recruited 40 patients to undergo a cardiopulmonary exercise test. CPET parameters related to the heart, lungs and muscles were recorded in real time, as the patient exercised on the bike to maximal effort.
The CPET data were then analysed to answer the above-mentioned clinical gaps. To disseminate the findings, the investigators plan to present the results at scientific, clinical, and patient group meetings and publish the findings in medical journals, to reach a wide array of healthcare professionals and policymakers.
详细描述
The Patient Public Involvement (PPi) panel was formed. To recruit PPi members for the present study, a poster was developed to invite people to join the PPi group. It was posted on social media and shared with local community groups and as a result, a four-member PPi panel was formed during the study development phase. The PPi group consisted of 3 males and 1 female. All four PPi group members had been diagnosed and living with heart failure for over 10 years. The PPi group members gave their valuable input:
- To enhance the acceptability and feasibility of the study by helping to optimize the testing protocol for patient comfort and safety.
- To ensure that patient information materials and consent processes were clear, patient-friendly and understandable.
- To improve recruitment by identifying potential barriers by providing strategies such as waving off hospital parking ticket fee.
- To direct the objectives and interpretation of research findings in a way that is meaningful to the patients and the public.
The study was conducted in compliance with the data protection regulations and ethical research practices. Measures were taken to safeguard participant information and research data. All data collection, storage and processing adhered to the UK General Data Protection Regulation (GDPR) principles thus maintaining data integrity and confidentiality. Personal identifiable patient data was anonymised by allocating each patient a study number/ID. A master file was created and stored separately that linked the patient files with the anonymised data sheets. Anonymised data was used for SPSS analysis and for any results presentation purposes.
As part of the biological Quality Control, a healthy subject volunteered to undergo cardiopulmonary testing at 2 separate times (start and end) during the data collection.
A multi-stage consent approach was practiced. Patients were contacted via phone call by the cardiology registrar (direct care team), briefly explaining the study details and seeking interest and verbal consent to post out the participant information sheet (PIS). The contact details of those patients were passed on to the external research team (PhD researcher). Days later, those patients were contacted again via phone call by the clinical researcher explaining the study in detail, answering queries and asking their verbal consent to send out a formal appointment letter for a mutually agreed date and time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female
- •Age range between 18 - 80 years
- •Clinical suspicion of Heart failure with preserved ejection fraction
- •Ejection Fraction of ≥50% on the most recent Echocardiogram
- •Able to understand the performance of an exercise test and the ability to provide consent
- •Ability to undertake leg exercise without any impediment
排除标准
- •• Hospital admission in the past 6 months
- •Unable to understand the performance of an exercise test
- •Unable to provide informed consent
- •Female subjects who are knowingly pregnant or believe they may be pregnant
- •Having an impediment preventing them from performing cycle ergometry
- •Contra-indication of CPET: acute myocardial infarction, unstable angina, uncontrolled arrhythmias, moderate or severe valvular disease, High-degree atrioventricular block, acute infection, acute endocarditis, myocarditis, uncontrolled asthma, and history of syncope.
研究组 & 干预措施
Patents referred to Cardiology Department with a clinical suspicion of HFpEF
Males and Females Age range: 18 to 80 Ejection fraction >50% on the latest Echocardiography No Hospital admission in the past 6 months No pregnant No absolute contraindication for conducting an exercise test.
干预措施: Cardiopulmonary Exercise Test (Other)
结局指标
主要结局
Maximum Oxygen Consumption at peak exercise (VO2peak)
时间窗: CPET testing day. VO2peak is recorded as the oxygen consumption value measured by the gas sensor at the peak of exercise, i.e., seconds before maximal exhaustion.
Measure of exercise capacity.
次要结局
- First Ventilatory Threshold(CPET testing day. Measured during the initial 3 minutes of the incremental test phase.)
- Heart Rate(Baseline, every 2 minutes interval, and at peak exercise near maximal exhaustion.)
- Blood Pressure(Every 3-minute interval during the exercise test.)