ISRCTN78539530已完成未知
A single-centre randomised controlled pilot trial to assess the feasibility of a definitive trial of the clinical effectiveness and cost effectiveness of the HF Manual in patients with heart failure with preserved ejection fraction and their caregivers (REACH-HFpEF)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27798024 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29632081 results (added 29/01/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33407893/ process evaluation (added 12/01/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36759035/ Secondary analysis (added 10/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged =18 years
- •2. Patients with heart failure, defined by the presence of at least one of the following symptoms at the time of screening:
- •2.1. Paroxysmal nocturnal dyspnoea
- •2.2. Orthopnoea
- •2.3. Dyspnoea on mild or moderate exertion
- •AND at least one of the following signs prior to study entry:
- •2.4. Basal crepitations
- •2.5. Elevated jugular venous pressure
- •2.6. Lower extremity oedema
- •2.7. Chest radiograph demonstrating pleural effusion, pulmonary congestion or cardiomegaly
- •3. Patients with left ventricular ejection fraction (EF) =45% obtained within 6 months prior to randomization and after any myocardial infarction (MI) or other event that would affect EF (ideally obtained by echocardiography, although radionuclide ventriculography and angiography are acceptable)
- •4. Provision of informed consent to participate.
排除标准
- •1. Patients who have undertaken cardiac rehabilitation (CR) within the last six months
- •2. Patients with severe chronic pulmonary disease defined as requiring home oxygen or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator
- •3. Patients who have any of the following contraindications to exercise testing or exercise training (adapted from ESC HF guidelines) documented in their medical notes:
- •3.1. Early phase after acute coronary syndrome (up to 2 days)
- •3.2. Untreated life-threatening cardiac arrhythmias
- •3.3. Acute heart failure (during the initial period of haemodynamic instability)
- •3.4. Uncontrolled hypertension (SBP >200 and/or DBP >100)
- •3.5. Advanced atrioventricular block
- •3.6. Acute myocarditis and pericarditis
- •3.7. Symptomatic aortic stenosis
- •3.8. Severe hypertrophic obstructive cardiomyopathy
- •3.9. Acute systemic illness
- •3.10. Intracardiac thrombus
- •3.11. Progressive worsening of exercise tolerance or dyspnoea at rest over previous 3–5 days
- •3.12. Significant ischaemia during low-intensity exercise (<2 METs, <50 W)
- •3.13. Uncontrolled diabetes (blood glucose >16 mmol/l or HbA1C >9% or equivalent unit)
- •3.14. Recent embolism
- •3.15. Thrombophlebitis
- •3.16. Recent-onset atrial fibrillation/atrial flutter (in the last 4 weeks)
- •4. Patients who are unable to understand the study information or unable to complete study procedures
- •5. Patients who are in a long-term care establishment or who are unwilling or unable to travel to research assessments or accommodate home visits
- •6. Patients judged to be unable to participate in the study for any other reason, e.g. psychiatric disorder, diagnosis of dementia, life-threatening co-morbidity
- •7. Patients participating in concurrent interventional research which may over-burden the patient or confound data collection
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