NL-OMON54508招募中2 期
Effects of a single oral dose of Ketone ester ON Exercise performance in patients with chronic Heart Failure - KETONE-HF
niversitair Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Chronic Heart Failure NYHA II - III
- •- LVEF<=40%
- •- Stable for the last 1 months prior to the study
- •- Chronic Heart Failure NYHA II - III
- •- HFpEF based on HFaPEFF score >= 5
- •- LVEF >= 45 %
- •- Stable for the last 1 month prior to the study
排除标准
- •- Age <18 years;
- •- Unable or unwilling to undergo exercise MRI (physical disabilities,
- •claustrophobia);
- •- VO2peak >80% of expected and or/a cycling time of <8 minutes on recent
- •exercise testing;
- •- Comorbidities which can influence study results such as muscular dystrophies,
- •peripheral artery disease, insulin dependent diabetes mellitus, severe anaemia
- •(defined as Hb <=6 mmol/L);
- •- Pregnant/trying to get pregnant/breastfeeding during the period from the
- •first exercise test until 4 weeks after the last exercise test);
- •- Absolute contra-indications to undergo MRI according to the current UMCG
- •protocols and guidelines (e.g. non-conditional medical device, recent device
- •implantation, incompatible ferromagnetic objects in the body);
- •- BMI < 16 kg/m2; BMI > 40 kg/m2;
- •- Unable to understand study procedures;
- •- Unable or unwilling to provide informed consent.
- •- Age <18 years;
- •- Unable or unwilling to undergo exercise MRI (physical disabilities,
- •claustrophobia);
- •- VO2peak >80% of expected and or/a cycling time of <8 minutes on recent
- •exercise testing;
- •- Comorbidities which can influence study results such as muscular dystrophies,
- •peripheral artery disease, insulin dependent diabetes mellitus, severe anaemia
- •(defined as Hb <=6 mmol/L), hypertrophic cardiomyopathy with outflow tract
- •obstruction and/or moderate to severe heart valve disease;
- •- Pregnant/trying to get pregnant/breastfeeding during the period from the
- •first exercise test until 4 weeks after the last exercise test);
- •- Absolute contra-indications to undergo MRI according to the current UMCG
- •protocols and guidelines (e.g. non-conditional medical device, recent device
- •implantation, incompatible ferromagnetic objects in the body).
- •- BMI < 16 kg/m2; BMI > 40 kg/m2
- •- Estimated glomular filtration rate <30
- •- Unable to understand study procedures;
- •- Unable or unwilling to provide informed consent.
研究者
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