Statin Adverse ReactionNCT04986241
The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation
An observational study of Statin Adverse Reaction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Statin Adverse Reaction
- What is being tested?
- Statin, Physical activity and Sedentary
- How many people
- 18,557 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2019to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Maximal Cardiopulmonary Test on treadmill or bike.
- Test considered maximum from the metabolic point of view (Respiratory Quotient >1.10).
Who cannot join
- Incomplete patient data.
- Incomplete exam data.
- Chronic obstructive pulmonary disease
- Diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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).
Read the 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.
- Conditions
- Statin Adverse Reaction
- Being tested
- Statin, Physical activity, Sedentary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor
Chronic use of statin prescribed previously by the assistant physician.
Physical activityOther
Also called Physical exercise
Physically active participants
SedentaryOther
Also called Physical inactivity
Physically inactive or sedentary participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Statin; Other: Physical activity | |
| Healthy sedentary Without Statin | Sedentary and healthy participant without use of statin; Without statin in the last 6 months. Receives: Other: Sedentary | |
| Healthy sedentary With Statin | Participant with dyslipidemia and sedentary with current use of statin. Receives: Drug: Statin; Other: Sedentary | |
| Healthy physically active Without Statin | Healthy, physically active participant without use of statin; Without statin in the last 6 months. Receives: Other: Physical activity | |
| Healthy physically active With Statin | Participant with dyslipidemia and physically active with current use of statin. Receives: Drug: Statin; Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1998 to 2017
Secondary outcomes (4)
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.
Measured: From 1998 to 2017
Sex differences
To determine whether sex (men and women) is associated with statins and cardiorespiratory fitness impairment.
Measured: From 1998 to 2017
Cardiovascular mortality
To determine the association of functional capacity and cardiorespiratory fitness with cardiovascular mortality.
Measured: From 1998 to 2017
All-cause mortality
To determine the association of functional capacity and cardiorespiratory fitness with all-cause mortality.
Measured: From 1998 to 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start20 Sep 2019
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18,557 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo R dos Santo, PhD, Principal investigator, Instituto do Coracao (InCor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986241
- Sponsor's protocol ID
- CardioRehab Bank Study
- Status last verified
- Oct 2022
- First submitted
- 21 Jul 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04986241
- Acronym / sponsor ID
- CardioRehab Bank Study
- Conditions
- Statin Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,557 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sedentary Heart Failure with Reduced Ejection Fraction Without Statin | – | Other: SedentarySedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; Without statin in the last 6 months. |
| Sedentary Heart Failure with Reduced Ejection Fraction With Statin | – | Drug: Statin, Other: SedentarySedentary Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin. |
| Physically active Heart Failure with Reduced Ejection Fraction Without Statin | – | Other: Physical activityPhysically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; Without statin in the last 6 months. |
| Physically active Heart Failure with Reduced Ejection Fraction With Statin | – | Drug: Statin, Other: Physical activityPhysically active Heart Failure with Reduced Ejection Fraction determined by echocardiogram; With current use of statin. |
| Healthy sedentary Without Statin | – | Other: SedentarySedentary and healthy participant without use of statin; Without statin in the last 6 months. |
| Healthy sedentary With Statin | – | Drug: Statin, Other: SedentaryParticipant with dyslipidemia and sedentary with current use of statin. |
| Healthy physically active Without Statin | – | Other: Physical activityHealthy, physically active participant without use of statin; Without statin in the last 6 months. |
| Healthy physically active With Statin | – | Drug: Statin, Other: Physical activityParticipant with dyslipidemia and physically active with current use of statin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Maximal Cardiopulmonary Test on treadmill or bike.
- Test considered maximum from the metabolic point of view (Respiratory Quotient >1.10).
Key exclusion criteria (4 listed)
- Incomplete patient data.
- Incomplete exam data.
- Chronic obstructive pulmonary disease
- Diagnosis of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinAlso: 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitorChronic use of statin prescribed previously by the assistant physician. | Drug | 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 activityAlso: Physical exercisePhysically active participants | Other | 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 |
| SedentaryAlso: Physical inactivityPhysically inactive or sedentary participants. | Other | 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 |
Primary outcome
Cardiorespiratory Fitness
Time frame: From 1998 to 2017
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.
4 secondary outcomes
Types of statins in Cardiorespiratory Fitness
Time frame: From 1998 to 2017
Sex differences
Time frame: From 1998 to 2017
Cardiovascular mortality
Time frame: From 1998 to 2017
All-cause mortality
Time frame: From 1998 to 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo R dos Santo, PhD principal investigator
Instituto do Coracao (InCor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Statin Adverse Reaction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: From 1998 to 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.