Clinical trial

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)

Name
CardioRehab Bank Study
Description
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).
Trial arms
Trial start
2019-09-20
Estimated PCD
2023-06-20
Trial end
2023-06-20
Status
Completed
Treatment
Statin
Chronic use of statin prescribed previously by the assistant physician.
Arms:
Healthy physically active With Statin, Healthy sedentary With Statin, Physically active Heart Failure with Reduced Ejection Fraction With Statin, Sedentary Heart Failure with Reduced Ejection Fraction With Statin
Other names:
3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor
Physical activity
Physically active participants
Arms:
Healthy physically active With Statin, Healthy physically active Without Statin, Physically active Heart Failure with Reduced Ejection Fraction With Statin, Physically active Heart Failure with Reduced Ejection Fraction Without Statin
Other names:
Physical exercise
Sedentary
Physically inactive or sedentary participants.
Arms:
Healthy sedentary With Statin, Healthy sedentary Without Statin, Sedentary Heart Failure with Reduced Ejection Fraction With Statin, Sedentary Heart Failure with Reduced Ejection Fraction Without Statin
Other names:
Physical inactivity
Size
18557
Primary endpoint
Cardiorespiratory Fitness
From 1998 to 2017
Eligibility criteria
Inclusion Criteria: * Maximal Cardiopulmonary Test on treadmill or bike. * Test considered maximum from the metabolic point of view (Respiratory Quotient \>1.10). Exclusion Criteria: * Incomplete patient data. * Incomplete exam data. * Chronic obstructive pulmonary disease * Diagnosis of cancer
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 18557, 'type': 'ACTUAL'}}
Updated at
2023-12-01

1 organization

1 product

1 indication

Product
Statin