MedDataX Logo

The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation

NCT ID: NCT04986241

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18557 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-20

Study Completion Date

2023-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Statin Adverse Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Sedentary

Intervention Type OTHER

Physically inactive or sedentary participants.

Sedentary Heart Failure with Reduced Ejection Fraction With Statin

Sedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin.

Statin

Intervention Type DRUG

Chronic use of statin prescribed previously by the assistant physician.

Sedentary

Intervention Type OTHER

Physically inactive or sedentary participants.

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.

Physical activity

Intervention Type OTHER

Physically active participants

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.

Statin

Intervention Type DRUG

Chronic use of statin prescribed previously by the assistant physician.

Physical activity

Intervention Type OTHER

Physically active participants

Healthy sedentary Without Statin

Sedentary and healthy participant without use of statin; Without statin in the last 6 months.

Sedentary

Intervention Type OTHER

Physically inactive or sedentary participants.

Healthy sedentary With Statin

Participant with dyslipidemia and sedentary with current use of statin.

Statin

Intervention Type DRUG

Chronic use of statin prescribed previously by the assistant physician.

Sedentary

Intervention Type OTHER

Physically inactive or sedentary participants.

Healthy physically active Without Statin

Healthy, physically active participant without use of statin; Without statin in the last 6 months.

Physical activity

Intervention Type OTHER

Physically active participants

Healthy physically active With Statin

Participant with dyslipidemia and physically active with current use of statin.

Statin

Intervention Type DRUG

Chronic use of statin prescribed previously by the assistant physician.

Physical activity

Intervention Type OTHER

Physically active participants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Statin

Chronic use of statin prescribed previously by the assistant physician.

Intervention Type DRUG

Physical activity

Physically active participants

Intervention Type OTHER

Sedentary

Physically inactive or sedentary participants.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor Physical exercise Physical inactivity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marcelo R dos Santo, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coracao (InCor)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marcelo Rodrigues dos Santos

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CardioRehab Bank Study

Identifier Type: -

Identifier Source: org_study_id