The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation

NCT04986241 | Completed

• 1 other identifier: CardioRehab Bank Study
• Study Type: observational
• Target: 18,557
• Locations: 1 country
• Sites: 1

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).

Conditions

Statin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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.

  From 1998 to 2017

Secondary Outcomes (4)

• Types of statins in Cardiorespiratory Fitness

  From 1998 to 2017

• Sex differences

  From 1998 to 2017

• Cardiovascular mortality

  From 1998 to 2017

• All-cause mortality

  From 1998 to 2017

Study Arms (8)

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.

Other: Sedentary

Sedentary Heart Failure with Reduced Ejection Fraction With Statin

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 Without Statin

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 With Statin

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

Drug: Statin; Other: Physical activity

Healthy sedentary Without Statin

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

Other: Sedentary

Healthy sedentary With Statin

Participant with dyslipidemia and sedentary with current use of statin.

Drug: Statin; Other: Sedentary

Healthy physically active Without Statin

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

Other: Physical activity

Healthy physically active With Statin

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

Drug: Statin; Other: Physical activity

Interventions

Statin DRUG

Chronic use of statin prescribed previously by the assistant physician.

Also known as: 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor

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

Physical activity OTHER

Physically active participants

Also known as: Physical exercise

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

Sedentary OTHER

Physically inactive or sedentary participants.

Also known as: Physical inactivity

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Maximal Cardiopulmonary Test on treadmill or bike.
• Test considered maximum from the metabolic point of view (Respiratory Quotient \>1.10).

You may not qualify if:

• Incomplete patient data.
• Incomplete exam data.
• Chronic obstructive pulmonary disease
• Diagnosis of cancer

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Marcelo Rodrigues dos Santos

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Exercise

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marcelo R dos Santo, PhD

  Instituto do Coracao (InCor)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 2, 2021
• Study Start: September 20, 2019
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: December 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)