ISRCTN47894539进行中（未招募）未知
Randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: The REACH-HFpEF Trial
HS Greater Glasgow and Clyde0 个研究点目标入组 520 人开始时间: 2021年7月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 520
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 03/04/2024:
- •1. Women or men aged =18 years
- •2. Currently symptomatic HF (NYHA Class II-IV)
- •3. Prescribed loop diuretics and the need for intermittent loop diuretics for the management of symptoms or signs of congestion
- •4. Left ventricular ejection fraction (LVEF) (within 3 years by echocardiography or MRI) =45% prior to randomisation. If Simpsons LVEF is missing, please use the qualitative eyeball assessment and assign a quantitative value as previously described for the BIOSTAT-CHF validation cohort [62]:
- •4.1. Severe: 25%
- •4.2. Moderate to severe: 30%
- •4.3. Moderate: 35%
- •4.4. Mild to moderate: 40%
- •4.5. Mild: 44%
- •4.6. Normal: 55%
- •Patients defined as a ‘normal’ LVEF would therefore meet this inclusion criteria.
- •5. At least one of the following risk factors:
- •5.1. Hospital admission in last 3 years for which HF was a major contributor
- •5.2. N-terminal proBNP >300 pg/ml for patients with sinus rhythm in last 3 years
- •5.3. N-terminal proBNP >900 pg/ml for patients in atrial fibrillation in last 3 years
- •B-type natriuretic peptide (BNP) and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) levels differ in their values. Guided by the latest ESC 2021 guideline [63] values for BNP and NT-proBNP in the diagnosis of HFpEF and the conversion factor based on these values, the BNP cut offs for the REACH-HFpEF trial are as below:
- •5.4. 100 pg/ml (If in sinus rhythm)
- •5.5. 300 pg/ml (if in atrial fibrillation)
- •6. Informed consent to participate.
- •Caregivers:
- •1. Women or men aged =18 years
- •2. Providing unpaid support to patients
- •Cardiac rehabilitation facilitators:
- •1. Health care professionals facilitating and trained in the REACH-HF intervention delivery.
- •2. Health care professionals delivering the REACH-HF intervention to participants in the REACH-HFpEF trial.
- •Previous participant inclusion criteria:
- •1. Women or men aged =18 years
- •2. Currently symptomatic HF (NYHA Class II-IV)
- •3. Prescribed loop diuretics and the need for intermittent loop diuretics for the management of symptoms or signs of congestion
- •4. Left ventricular ejection fraction (by echocardiography) =45% within 12 months prior to randomisation
- •5. At least one of the following risk factors:
- •5.1. Hospital admission in last 12 months for which HF was a major contributor
- •5.2. N-terminal proBNP >300 pg/ml for patients with sinus rhythm
- •5.3. N-terminal proBNP >900 pg/ml for patients in atrial fibrillation
- •6. Informed consent to participate
- •Caregivers:
- •1. Women or men aged =18 years
- •2. Providing unpaid support to patients
排除标准
- •Current participant exclusion criteria as of 03/04/2024:
- •1. Patients who have undertaken CR within the last 12 months
- •2. Patients who have any contraindications to exercise training (according to local cardiac rehabilitation guidelines)
- •3. Probable alternative diagnoses that in the opinion of the investigator could account for the patient’s HF symptoms (i.e. dyspneoa, fatigue), such as significant pulmonary disease (including primary pulmonary hypertension), anaemia, or obesity. Specifically, patients with the following should be excluded:
- •3.1. Severe pulmonary disease including COPD (i.e. requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalised for pulmonary decompensation within 12 months)
- •3.2. Haemoglobin <10 g/dll
- •3.3. BMI >40 kg/m²;
- •4. Patients with prior ejection fraction <45%.
- •5. Patients located in a long-term care home/support setting who are considered to be too frail to engage with the intervention or who are unwilling to travel to research assessments or accommodate home visits.
- •6. Patients who are unable to understand the study information or unable to complete the outcome questionnaires.
- •7. 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).
- •Previous participant exclusion criteria:
- •1. Patients who have undertaken CR within the last 12 months
- •2. Patients who have any contraindications to exercise training
- •3. Patients who have alternative reasons for shortness of breath such as significant pulmonary disease or severe COPD, haemoglobin <10 g/dl, or body mass index (BMI) >40 kg/m²
- •4. Patients with prior ejection fraction <45%
- •5. eGFR <30 ml/min
研究者
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