Clinical trial NCT04986241: The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Statin Adverse Reaction
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 18557
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: 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.

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

Primary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: From 1998 to 2017
Secondary outcomes:
measure: Types of statins in Cardiorespiratory Fitness
timeFrame: From 1998 to 2017
measure: Sex differences
timeFrame: From 1998 to 2017
measure: Cardiovascular mortality
timeFrame: From 1998 to 2017
measure: All-cause mortality
timeFrame: From 1998 to 2017
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Marcelo Rodrigues dos Santos
state: Sao Paulo
Study officials:
affiliation: Instituto do Coracao (InCor)
name: Marcelo R dos Santo, PhD
role: PRINCIPAL_INVESTIGATOR
References: