A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- Changes in stress-triggered response of catecholamines.
研究概览
简要总结
Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years.
A critical illness mechanism in heart failure is that these patients have high blood levels of catecholamines; epinephrine and norepinephrine, which is stress hormones from the sympathetic nervous system. Standard treatment of heart failure is with the two medical preparations betablockers and ACE-inhibitors.
It is not known what effect betablocker-treatment have on blood concentration of epinephrine and norepinephrine.
It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the blood concentration of epinephrine and norepinephrine. This is done by creating a stress condition for the body, in this case with the bicycle test, while doing blood samples to determine the concentration of catecholamines. This will be done by 1-week treatment of tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical effect). Blood samples will be taken to determine small changes in inheritance material (DNA) in the form of point mutations also called single nucleotide polymorphisms, since these changes can affect how we respond to metoprolol treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men
- •18 years < age < 30 years
- •Non-smoker
- •18 < BMI < 25
- •No chronic diseases
- •Motor-disability that disables completement of cardio-pulmonary exercise-test.
排除标准
- •Alcohol abuse or any other abuse
- •Intake of any narcotic drugs (example: cannabinoids, narcotics, stimulants of central nervous system, hypnotics, hallucinogenes)
- •Any of following medication:
- •astmamedication
- •heartmedication
- •antihistamines
- •antipsycotics
- •rifampicine
- •chinidine
- •glucocorticoids
- •Abnormal ECG, particularly
- •degree AV-block, sinusbradycardia, sick sinusnode-syndrome, sign of heart failure or ischemia.
- •Allergy or intolerance of metoprolole
- •Lactoseallergy
- •110 mmHg < Systolic blood pressure < 140 mmHg
- •60 mmHg < Diastolic blood pressure < 90 mmHg
- •Bloodsucker > 11,1 mmol/L, or fasting, venous bloodsucker >= 7,0 (measured if: 7,8 < BS < 11,1)
研究组 & 干预措施
1
Metoprolol for 10 days followed by placebo for 7 days.
干预措施: Metoprolole (Selo-Zok ®) (Drug)
1
Metoprolol for 10 days followed by placebo for 7 days.
干预措施: Placebo (Drug)
2
Placebo for 7 days followed by Metoprolol for 10 days
干预措施: Metoprolole (Selo-Zok ®) (Drug)
2
Placebo for 7 days followed by Metoprolol for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in stress-triggered response of catecholamines.
时间窗: 2 weeks and 3 days
次要结局
- Change in stress-triggered blood pressure response.(2 weeks and 3 days)
- Change in stress-triggered pulse response.(2 weeks and 3 days)