Retrospective Study of the Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation: Database of the Cardiovascular Rehabilitation and Exercise Physiology Department of Heart Institute (InCor)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,557
- 试验地点
- 1
- 主要终点
- Cardiorespiratory Fitness
研究概览
简要总结
Statins are part of one of the largest groups of drugs prescribed worldwide used in the treatment of dyslipidemia. Despite the good therapeutic results of statins and their good tolerance on the part of patients, some adverse effects may occur during treatment. In skeletal muscle, statins can lead to mitochondrial dysfunction characterized by decreased adenosine triphosphate production, decreased oxidative phosphorylation capacity, increased concentration of reactive oxygen species, and decreased mitochondrial biogenesis.
Cardiorespiratory fitness is a physiological indicator that corresponds to the integration of the cardiovascular, pulmonary, muscular, and cellular (mitochondria) systems in capturing, transporting and using oxygen, commonly expressed as the maximum oxygen consumption. Several studies show a strong association of lower cardiorespiratory capacity with an increased risk of mortality from cardiovascular disease and mortality from all causes.
Combining the use of statins with lifestyle changes has been suggested in many medical guidelines. Physical exercise plays a fundamental role in improving cardiorespiratory fitness and controlling dyslipidemia. However, some studies suggest that the association of statin with physical training can negatively influence the adaptation and improvement of cardiorespiratory capacity. On the other hand, some studies show that the combination of statin and physical exercise does not negatively interfere with the maximum oxygen consumption.
To determine the impact of statins on cardiorespiratory fitness and adaptation to physical exercise, the investigators will use the database of the Cardiovascular Rehabilitation and Exercise Physiology Department at Heart Institute (Sao Paulo, Brazil), which currently has 33,804 maximal cardiopulmonary exercise tests. This large database, which is the gold standard of cardiorespiratory capacity (maximum oxygen consumption), will be used retrospectively with relevant information and a huge number of participants.
Therefore, the aim of this study will be to explore a large database to assess the effect of the use of statins and their relationship with cardiorespiratory capacity in physically active and sedentary individuals (with and without heart failure).
详细描述
The investigators will use the database of the Cardiovascular Rehabilitation and Exercise Physiology Department at Heart Institute (Sao Paulo, Brazil) in an exploratory manner. The investigators will use filters to perform different analyzes and sub-analyses with different groups of patients. The investigators aimed to compare patients using statins and healthy controls (not using medications). The analysis strategy will be as following: 1) physically active and sedentary patients with normal cardiac function using statins and peak oxygen consumption (peak VO2); 2) physically active and sedentary patients with cardiac dysfunction (heart failure) using statins and peak VO2; 3) comparison between the hydrophilic and lipophilic classes of statins; 4) comparison between men and women; 5) retrospective information on clinical and laboratory variables and 6) test information on cardiorespiratory capacity and several variables associated with the mortality outcome.
The participants underwent cardiopulmonary exercise testing on a treadmill or bike (SensorMedics - Vmax Analyzer Assembly, Encore 29S) following a ramp protocol with constant load increase until exhaustion. Cardiorespiratory capacity will be determined by peak VO2, assessed at maximum exercise intensity, with a respiratory exchange ratio >1.10.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maximal Cardiopulmonary Test on treadmill or bike.
- •Test considered maximum from the metabolic point of view (Respiratory Quotient >1.10).
排除标准
- •Incomplete patient data.
- •Incomplete exam data.
- •Chronic obstructive pulmonary disease
- •Diagnosis of cancer
研究组 & 干预措施
Healthy sedentary Without Statin
Sedentary and healthy participant without use of statin; Without statin in the last 6 months.
干预措施: Sedentary (Other)
Sedentary Heart Failure with Reduced Ejection Fraction Without Statin
Sedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; Without statin in the last 6 months.
干预措施: Sedentary (Other)
Sedentary Heart Failure with Reduced Ejection Fraction With Statin
Sedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.
干预措施: Statin (Drug)
Sedentary Heart Failure with Reduced Ejection Fraction With Statin
Sedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.
干预措施: Sedentary (Other)
Healthy sedentary With Statin
Participant with dyslipidemia and sedentary with current use of statin.
干预措施: Statin (Drug)
Physically active Heart Failure with Reduced Ejection Fraction Without Statin
Physically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; Without statin in the last 6 months.
干预措施: Physical activity (Other)
Physically active Heart Failure with Reduced Ejection Fraction With Statin
Physically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.
干预措施: Statin (Drug)
Physically active Heart Failure with Reduced Ejection Fraction With Statin
Physically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.
干预措施: Physical activity (Other)
Healthy sedentary With Statin
Participant with dyslipidemia and sedentary with current use of statin.
干预措施: Sedentary (Other)
Healthy physically active Without Statin
Healthy, physically active participant without use of statin; Without statin in the last 6 months.
干预措施: Physical activity (Other)
Healthy physically active With Statin
Participant with dyslipidemia and physically active with current use of statin.
干预措施: Statin (Drug)
Healthy physically active With Statin
Participant with dyslipidemia and physically active with current use of statin.
干预措施: Physical activity (Other)
结局指标
主要结局
Cardiorespiratory Fitness
时间窗: From 1998 to 2017
To determine whether the use of statins impairs the adaptation of the cardiorespiratory fitness in physically active individuals, with and without left ventricular dysfunction (heart failure), when compared with a matched sedentary control group.
次要结局
- Types of statins in Cardiorespiratory Fitness(From 1998 to 2017)
- Sex differences(From 1998 to 2017)
- All-cause mortality(From 1998 to 2017)
- Cardiovascular mortality(From 1998 to 2017)