Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ΔPi/PCr from baseline to maximum exercise
研究概览
简要总结
Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF).
详细描述
Iron Deficiency (ID) is a comorbidity in heart failure (HF) patients with high prevalence and severe clinical consequences. Multiple studies have shown that ID in HF patients impairs exercise capacity, quality of life and outcome. It is currently unknown whether these detrimental consequences of ID are due to cardiovascular or hematologic effects, or deteriorated peripheral muscle metabolism and function. This study was designed to quantify the effect of ID on skeletal oxidative metabolism in patients with chronic HF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •For HFrEF patients:
- •Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
- •Stable, evidence-based medical therapy for HF;
- •LVEF <40% measured <5 year prior to inclusion;
- •NYHA class II - III (symptomatic HF) at moment of inclusion;
- •For HFpEF patients:
- •Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
- •LVEF >40% and one of the following parameters, measured <5 year prior to inclusion;
- •Left atrial volume index (LAVI) >34 mL/m2 or
- •left ventricular mass index ≥115 g/m2 (for males) or ≥95 g/m2 (for females) or
- •E/e' ≥13 or
- •mean e' (septal and lateral) <9 cm/s
- •NYHA class II - III (symptomatic HF) at moment of inclusion;
- •Serum NT-proBNP ≥125 pg/mL when in sinus rhythm; >300 pg/mL when in atrial fibrillation.
- •Additional inclusion criterion for subjects with ID:
- •Iron deficiency, defined as TSAT <20%.
排除标准
- •Age <18 years;
- •Unable or unwilling to undergo exercise MRI (e.g. pregnancy, physical disabilities, claustrophobia);
- •The presence of ferromagnetic material in/on the body which cannot be removed (e.g. non-MRI-compatible cardiac devices, tattoos containing ferrous ink);
- •History of erythropoietin stimulating agent, intravenous iron therapy and/or blood transfusion <3 months prior to study enrolment;
- •Moderate anaemia, defined as Hb <7 mmol/L for both men and women;
- •Oral iron therapy >100 mg/day <4 weeks prior to study enrolment;
- •Unable to understand study procedures;
- •Unable or unwilling to provide informed consent.
结局指标
主要结局
ΔPi/PCr from baseline to maximum exercise
时间窗: During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Δ ratio of inorganic phosphate/Phosphocreatinin concentrations from baseline to maximum exercise
次要结局
- PCr recovery rate during recovery(During study visit, from maximum exercise to end of recovery (upto at least 5 minutes after end of exercise))
- Maximal exercise performance(During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes))
- Intramuscular pH(During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes))
研究者
Peter van der Meer, MD PhD
Prof. dr. Peter van der Meer
University Medical Center Groningen