An observational study in Statin Adverse Reaction, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University of Sao Paulo General Hospital · Observational
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).
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.
University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population of the study are patients admitted in the Cardiovascular Rehabilitation and Exercise Physiology Department at Heart Institute Hospital (Sao Paulo, Brazil) for a cardiopulmonary exercise test.
Exclusion Criteria:
Sedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; Without statin in the last 6 months.
Other: Sedentary
Sedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.
Drug: Statin · Other: Sedentary
Physically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; Without statin in the last 6 months.
Other: Physical activity
Physically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.
Drug: Statin · Other: Physical activity
Sedentary and healthy participant without use of statin; Without statin in the last 6 months.
Other: Sedentary
Participant with dyslipidemia and sedentary with current use of statin.
Drug: Statin · Other: Sedentary
Healthy, physically active participant without use of statin; Without statin in the last 6 months.
Other: Physical activity
Participant with dyslipidemia and physically active with current use of statin.
Drug: Statin · Other: Physical activity
Chronic use of statin prescribed previously by the assistant physician.
Also known as: 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor
Physically active participants
Also known as: Physical exercise
Physically inactive or sedentary participants.
Also known as: Physical inactivity
Cardiorespiratory Fitness
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.
Time frame: From 1998 to 2017
Types of statins in Cardiorespiratory Fitness
To determine whether the type of statins (lipophilic or hydrophilic) has any adverse effect on the cardiorespiratory fitness in physically active individuals, with and without left ventricular dysfunction (heart failure), when compared with a matched sedentary control group.
Time frame: From 1998 to 2017
Sex differences
To determine whether sex (men and women) is associated with statins and cardiorespiratory fitness impairment.
Time frame: From 1998 to 2017
Cardiovascular mortality
To determine the association of functional capacity and cardiorespiratory fitness with cardiovascular mortality.
Time frame: From 1998 to 2017
All-cause mortality
To determine the association of functional capacity and cardiorespiratory fitness with all-cause mortality.
Time frame: From 1998 to 2017
Plan to share: No
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University of Sao Paulo General Hospital