NCT04173117终止不适用
A Low-energy Meal Replacement Plan for Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes: A Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Recruitment and retention rates
研究概览
简要总结
Open, Single arm intervention, feasibility study
详细描述
The aims of the proposed feasibility study are to assess whether a low-energy meal replacement plan (MRP) in patients with HFpEF and T2D:
- Is acceptable to an older, co-morbid, multi-ethnic population
The secondary objectives are to assess whether a low-energy MRP in patients with HFpEF and T2D may be:
- associated with improved symptoms
- likely to lead to favourable cardiovascular reverse remodelling
- likely to improve functional capacity and quality of life
- associated with favourable reductions in cardiovascular biomarkers
- associated with increased physical activity
- associated with favourable cardiovascular outcomes
All patients will undergo the following assessments at baseline, 12-weeks and 12 months (following MRP):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established T2D (HbA1c ≥6.5%, duration >3months)
- •Obesity (BMI ≥30 or ≥27 kg/m2 if black/south Asian ethnicity)
- •Symptoms limiting exercise capacity in normal daily activities (dyspnoea or fatigue) or an established diagnosis of HF
- •Diagnosis of HFpEF in accordance with European Society of Cardiology criteria: LV EF >50% with objective evidence of cardiac structural or functional alterations (LV hypertrophy (≥12mm); LV mass index ≥115g/m2 for males and ≥95g/m2 for females; E/e' ≥13 and a mean e' septal and lateral wall <9 cm/s; left atrial volume index >34mL/m2 or reduced global longitudinal strain (>-18%); elevated levels of natriuretic peptides (B-type natriuretic peptide >35pg/mL and/or NT-pro B-type natriuretic peptide >125pg/mL))
排除标准
- •Unwilling to undertake MRP (low energy diet)
- •HBa1c >10%
- •Diabetes duration >12 years
- •High-dose insulin requirement: either on full basal-bolus insulin regime or insulin requirement >1U/kg/day
- •Have been on insulin treatment >10 years
- •Current treatment with anti-obesity drugs
- •Diagnosed eating disorder or purging
- •Weight loss > 5kg in preceding 3 months (unless related to hospitalisation for HF)
- •Absolute contraindications to MRI
- •Severe renal impairment eGFR<30ml/min/m2
- •Myocardial infarction within preceding 6 months
- •History of substance abuse
- •Cancer undergoing active treatment
- •Unable to consent due to lack of mental capacity
- •Pregnancy/considering pregnancy
- •People unable to perform activities of daily living independently or unable attend for clinical appointments without a carer/attendant
- •Unable to read/understand English sufficiently to provide informed consent
结局指标
主要结局
Recruitment and retention rates
时间窗: 16 weeks
The number of people approached, recruited and retained
次要结局
- Differences in albumin concentration pre- and post intervention(12 weeks)
- Differences in albumin/creatinine ratio concentration pre- and post intervention(12 weeks)
- Differences in visceral adipose tissue mass (g) pre- and post intervention(12 weeks)
- Differences in visceral adipose tissue volume (cm3) pre- and post intervention(12 weeks)
- Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention(12 weeks)
- Differences in E (cm/s) pre- and post intervention(12 weeks)
- Differences in Average E/e' pre- and post intervention(12 weeks)
- Differences in Total lean body mass (g) pre- and post intervention(12 weeks)
- Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention(12 weeks)
- Differences in HbA1c (mmol/mol) pre- and post intervention(12 weeks)
- Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention(12 weeks)
- Differences in Lateral E/e' pre- and post intervention(12 weeks)
- Differences in LA volume indexed pre- and post intervention(12 weeks)
- Differences in TR jet velocity (m/s) pre- and post intervention(12 weeks)
- Differences in Bone Mineral Density (g/cm2) pre- and post intervention(12 weeks)
- Differences in E/A ratio pre- and post intervention(12 weeks)
- Differences in Septal e' pre- and post intervention(12 weeks)
- Differences in BMI pre- and post intervention(12 weeks)
- Difference in Medical Research Council Dyspnoea Scale pre- and post intervention(12 weeks)
- Differences in LV remodelling (indexed LV mass) pre- and post intervention(12 weeks)
- Differences in LV function pre- and post intervention(12 weeks)
- Differences in MV deceleration time (ms) pre- and post intervention(12 weeks)
- Differences in A (cm/s) pre- and post intervention(12 weeks)
- Differences in Lateral e' pre- and post intervention(12 weeks)
- Differences in Total tissue fat (%) pre- and post intervention(12 weeks)
- Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention(12 weeks)
- Differences in HbA1c (%) pre- and post intervention(12 weeks)
- Differences in 6 minute walk test pre- and post intervention(12 weeks)
- Differences in Septal E/e' pre- and post intervention(12 weeks)
- Differences in Total Fat mass (g) pre- and post intervention(12 weeks)
- Differences in Fasting Glucose (mmol/L) pre- and post intervention(12 weeks)
- Differences in B-type (ng/L) natriuretic peptide pre- and post intervention(12 weeks)
- Differences in LDL (mmol/L) pre- and post intervention(12 weeks)
- Differences in CRP (mg/L), natriuretic peptide pre- and post intervention(12 weeks)
- Differences in eGFR (ml/min) pre- and post intervention(12 weeks)
- Differences in hsTnl(ng/L) pre- and post intervention(12 weeks)
- Differences in hALT (iu/L) pre- and post intervention(12 weeks)
- Differences in liver function pre- and post intervention(12 weeks)
- Differences in Urea (mmol/L) pre- and post intervention(12 weeks)
- Differences in creatinine (umol/L) pre- and post intervention(12 weeks)
- Differences in ALP (iu/L)pre- and post intervention(12 weeks)
- Differences in sodium (mmol/L) pre- and post intervention(12 weeks)
- The number of participants who experience any Major Adverse Cardiovascular Events (MACE)(12 weeks)
- Differences in potassium (mmol/L) pre- and post intervention(12 weeks)
- Differences in kidney function pre- and post intervention(12 weeks)
- Differences in the levels of physical activity pre- and post intervention(12 weeks)
- Cardiac rehabilitation uptake(12 months)
研究者
研究点 (2)
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