Chronic Obstructive Pulmonary DiseaseNCT03943030
Cardiovascular Effects of Pulmonary Rehabilitation in COPD
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Introduction: Chronic obstructive pulmonary disease (COPD) is characterized by airflow obstruction, which is clinically manifested by dyspnea and leads the patient to a vicious cycle of sedentary lifestyle. Pulmonary rehabilitation (PR) is an important therapeutic strategy to break this cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Feb 2019to 18 Jul 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD;
- Stable patients (no exacerbation in the last 4 weeks).
Who cannot join
- Patients with contraindications to exercise (decompensated ischemic heart disease or neuromuscular diseases) or unable to perform evaluations and / or participate in the pulmonary rehabilitation program.
- Bood pressure greater than 160/90 mmHg,
- Serum cholesterol greater than 220,
- Diabetes mellitus,
- Active smoking or using vasodilator drugs (calcium channel blockers and ACE inhibitors).
- Use of β-blocker will be directed to ingest the last dose of this drug 24 hours before the measurement of endothelial function.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
About this study
Official title: Effects of Pulmonary Rehabilitation on Cardiovascular Parameters in Patients With COPD
Introduction: Chronic obstructive pulmonary disease (COPD) is characterized by airflow obstruction, which is clinically manifested by dyspnea and leads the patient to a vicious cycle of sedentary lifestyle. Pulmonary rehabilitation (PR) is an important therapeutic strategy to break this cycle. Cardiovascular diseases are frequent in patients with (COPD) and are associated with higher mortality. The effects of (PR) on cardiovascular risk factors in patients with (COPD) have been little studied so far. Objectives: To evaluate the effects of pulmonary rehabilitation compared to the control group on cardiovascular risk factors in patients with (COPD). Methods: A randomized clinical trial will be conducted. Patients with (COPD) will be divided into two groups: Group I (GI): group that will be rehabilitated, with 3 weekly sessions, for 8 weeks and Group II (GII): control group, without intervention. In both groups, a baseline evaluation will be performed, which will be repeated after 9 weeks and consists of: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI). Outcomes commonly used in the assistance to assess (PR) will also be measured. Expected Results: The study is expected to improve understanding of the impact of (PR) on cardiovascular variables in patients with (COPD).
Read the detailed description
Measures and instruments Before the rehabilitation program, a baseline evaluation will be performed, which will include: anthropometric evaluation, Framingham cardiovascular risk score calculation, (mMRC) scale completion, and International Physical Activity Questionnaire (IPAQ). Baseline lung function data will be obtained from patients' medical records. The severity of (COPD) will be determined by spirometric classification of the Gold consensus, Body-mass index, airflow obstruction, dyspnea, and exercise (BODE) and Gold (ABCD) scale. To evaluate exercise capacity, a 6-minute (s) walk test (6MWT), an incremental cardiopulmonary exercise test (ECT) on a cycle ergometer, and a cardiopulmonary exercise test with a constant load on a cycle ergometer will be performed. All patients will undergo evaluation of endothelial function and (ABI) (brachial ankle index). Laboratory tests, exercise tests, evaluation of endothelial function and (ABI) will be performed before and after the pulmonary rehabilitation program. Two visits will be necessary to carry out the tests: on the first visit blood will be collected for laboratory tests, the questionnaires will be answered, anthropometric data collected and the incremental (ECP) will be performed; at the second visit, the (ABI) and endothelial function will be measured and the constant load (TECP) will be performed. There will be a minimum of 48 hours between visits. The incremental (ECP) will be performed only at baseline. In the anthropometric evaluation will be determined the weight and the height, being calculated the body mass index through the formula; weight (kg) / height2 (m). Laboratory Tests Total cholesterol and fractions, triglycerides, C-reactive protein, fasting glycemia, Glutamic oxaloacetic transaminase (GOT), Glutamic-pyruvic transaminase (GPT), urea and creatinine and protein C will be collected baseline and after intervention. Pulmonary function Results of spirometry, pulmonary diffusion by carbon monoxide (DLco) and lung volumes (plethysmography) will be recorded, which are performed in the care routine and will be obtained from the patients' records. Exercise tests The (6MWT) will be performed in a 30 meter corridor, with continuous monitoring of peripheral oxygen saturation (SpO2) and heart rate. Before and after the test the respiratory rate and the intensity of the dyspnea will be determined. The distance covered in 6 minutes will be recorded. The test will be performed in accordance with the guidelines and predicted values previously described. The maximum incremental (TECP) limited by symptoms will be performed on an electromagnetic bicycle using a ramp protocol. After 2 minutes of standing monitoring, the patient will pedal for 2 minutes without load. The load ramp will be individualized so that the incremental test lasts between 8 and 12 minutes. The incremental (TECP) will be performed according to the recommendations of the. The constant load test will be performed with 75% of the maximum load reached in the incremental (TECP). During the tests performed on the exercise bicycle, the electrocardiographic tracing and (SpO2) will be continuously monitored. Significant desaturation will be considered when (SpO2) falls ≥ 3%. Endothelial function will be non-invasively assessed by flow-mediated dilatation in the brachial artery using a high-resolution ultrasound imaging device (SONOSITE®, M-Turbo, Sony). Brachial ankle index, the assessment of the systolic arterial pressure of the brachial arteries and posterior tibial arteries will be performed bilaterally using a portable vascular Doppler, with a sphygmomanometer positioned 3 cm above the cubital fossa in the upper limbs and 3 cm above the medial malleolus in the lower limbs. The randomization will be performed through an online software at www.random.org, then will be stored in a stealth location. A blinded investigator will generate a numerical sequence of the randomized patients who meet the eligibility criteria. The study was not done with the total number of patients diagnosed with (COPD). Those divided into two groups: intervention and control.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- Pulmonary rehabilitation, Chronic Obstructive Pulmonary Disease, Cardiovascular effects, Endothelial dysfunction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
The PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | The PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured. Receives: Other: Pulmonary rehabilitation |
| Group control | No intervention | The group will not receive pulmonary rehabilitation intervention. Patients will be guided and maintain their daily and routine lives normally during the evaluation process. However, a baseline evaluation will be performed, which will be repeated after 9 weeks: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes commonly used in the assistance to assess PR will also be measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dilatation mediated by the flow of the brachial artery
The flow-mediated dilatation of the brachial artery will be assessed non-invasively by the ultrasound device (SONOSITE®, M-Turbo, Sony). A high-frequency transducer (HFL38xp, SONOSITE®, Sony) will be used to obtain longitudinal images of the brachial artery walls.
Measured: Eight Weeks.
Secondary outcomes (16)
Brachial ankle index
The calibration of the brachial, pediatric and posterior tibial arteries bilaterally will be performed using a portable vascular Doppler.
Measured: Eight Weeks.
Body-mass Index
Evaluate the weight of a person in relation to their height.
Measured: Eight Weeks.
Airflow Obstruction
Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration.
Measured: Eight Weeks.
Dyspnea - Modified Medical Research Council (mMRC scale)
Evaluates dyspnea intensity, ranging from zero to four:
Grade 0 - No troubled by breathlessness except on strenous exercise. Grade 1 - Short of breath when hurryng or walking up a slight hill. Grade 2 - Walks slower than contemporaries on the level because of breathlessness or has to stop for breath when walking at own pace.
Grade 3 - Stops of breath after walking 100m or after a few minutes on the level.
Grade 4 - Too breathless to leave the house or breathless when dressing or undressing.
The scale is gradual according to the patient's dyspnea level
Measured: Eight Weeks.
Exercise Capacity
Distance traveled on the 6-min walk tes (6MWT).
Measured: Eight Weeks.
Laboratory Tests - Total cholesterol
Blood collection to measure total cholesterol performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - HDL cholesterol
Blood collection to measure HDL cholesterol performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - LDL cholesterol
Blood collection to measure LDL cholesterol performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - Triglycerides
Blood collection to measure triglycerides performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - C-reactive protein
Blood collection to measure C-reactive protein performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - Glutamic oxaloacetic transaminase (GOT)
Blood collection to measure GOT performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - Glutamic-pyruvic transaminase (GPT)
Blood collection to measure GPT performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - Urea
Blood collection to measure Urea performed at HCPA.
Measured: Eight Weeks.
Laboratory Tests - Creatinine
Blood collection to measure creatinine performed at HCPA.
Measured: Eight Weeks.
Anthropometric evaluation - Waist circumference
The position the tape measure at the point between the last rib and the iliac crest with the smallest measure.
Measured: Eight Weeks.
Anthropometric evaluation - Circumference of the hip
Twill be measured with a tape measure at the highest measurement on the hip.
Measured: Eight Weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start11 Feb 2019
- Primary completion18 Dec 2021
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial, performed with two groups: intervention and controls (usual care).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marli Knorst, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943030
- Sponsor's protocol ID
- 96766418100005327
- Status last verified
- Jul 2023
- First submitted
- 26 Jan 2019
- Last updated
- 28 Jul 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Cardiovascular Parameters in Patients With COPD
- ClinicalTrials.gov ID
- NCT03943030
- Acronym / sponsor ID
- 96766418100005327
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary rehabilitation, Chronic Obstructive Pulmonary Disease, Cardiovascular effects, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 9 May 2019 (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.
Introduction: Chronic obstructive pulmonary disease (COPD) is characterized by airflow obstruction, which is clinically manifested by dyspnea and leads the patient to a vicious cycle of sedentary lifestyle. Pulmonary rehabilitation (PR) is an important therapeutic strategy to break this cycle. Cardiovascular diseases are frequent in patients with (COPD) and are associated with higher mortality. The effects of (PR) on cardiovascular risk factors in patients with (COPD) have been little studied so far. Objectives: To evaluate the effects of pulmonary rehabilitation compared to the control group on cardiovascular risk factors in patients with (COPD). Methods: A randomized clinical trial will be conducted. Patients with (COPD) will be divided into two groups: Group I (GI): group that will be rehabilitated, with 3 weekly sessions, for 8 weeks and Group II (GII): control group, without intervention. In both groups, a baseline evaluation will be performed, which will be repeated after 9 weeks and consists of: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI). Outcomes commonly used in the assistance to assess (PR) will also be measured. Expected Results: The study is expected to improve understanding of the impact of (PR) on cardiovascular variables in patients with (COPD).
Detailed description
Measures and instruments Before the rehabilitation program, a baseline evaluation will be performed, which will include: anthropometric evaluation, Framingham cardiovascular risk score calculation, (mMRC) scale completion, and International Physical Activity Questionnaire (IPAQ). Baseline lung function data will be obtained from patients' medical records. The severity of (COPD) will be determined by spirometric classification of the Gold consensus, Body-mass index, airflow obstruction, dyspnea, and exercise (BODE) and Gold (ABCD) scale. To evaluate exercise capacity, a 6-minute (s) walk test (6MWT), an incremental cardiopulmonary exercise test (ECT) on a cycle ergometer, and a cardiopulmonary exercise test with a constant load on a cycle ergometer will be performed. All patients will undergo evaluation of endothelial function and (ABI) (brachial ankle index). Laboratory tests, exercise tests, evaluation of endothelial function and (ABI) will be performed before and after the pulmonary rehabilitation program. Two visits will be necessary to carry out the tests: on the first visit blood will be collected for laboratory tests, the questionnaires will be answered, anthropometric data collected and the incremental (ECP) will be performed; at the second visit, the (ABI) and endothelial function will be measured and the constant load (TECP) will be performed. There will be a minimum of 48 hours between visits. The incremental (ECP) will be performed only at baseline. In the anthropometric evaluation will be determined the weight and the height, being calculated the body mass index through the formula; weight (kg) / height2 (m). Laboratory Tests Total cholesterol and fractions, triglycerides, C-reactive protein, fasting glycemia, Glutamic oxaloacetic transaminase (GOT), Glutamic-pyruvic transaminase (GPT), urea and creatinine and protein C will be collected baseline and after intervention. Pulmonary function Results of spirometry, pulmonary diffusion by carbon monoxide (DLco) and lung volumes (plethysmography) will be recorded, which are performed in the care routine and will be obtained from the patients' records. Exercise tests The (6MWT) will be performed in a 30 meter corridor, with continuous monitoring of peripheral oxygen saturation (SpO2) and heart rate. Before and after the test the respiratory rate and the intensity of the dyspnea will be determined. The distance covered in 6 minutes will be recorded. The test will be performed in accordance with the guidelines and predicted values previously described. The maximum incremental (TECP) limited by symptoms will be performed on an electromagnetic bicycle using a ramp protocol. After 2 minutes of standing monitoring, the patient will pedal for 2 minutes without load. The load ramp will be individualized so that the incremental test lasts between 8 and 12 minutes. The incremental (TECP) will be performed according to the recommendations of the. The constant load test will be performed with 75% of the maximum load reached in the incremental (TECP). During the tests performed on the exercise bicycle, the electrocardiographic tracing and (SpO2) will be continuously monitored. Significant desaturation will be considered when (SpO2) falls ≥ 3%. Endothelial function will be non-invasively assessed by flow-mediated dilatation in the brachial artery using a high-resolution ultrasound imaging device (SONOSITE®, M-Turbo, Sony). Brachial ankle index, the assessment of the systolic arterial pressure of the brachial arteries and posterior tibial arteries will be performed bilaterally using a portable vascular Doppler, with a sphygmomanometer positioned 3 cm above the cubital fossa in the upper limbs and 3 cm above the medial malleolus in the lower limbs. The randomization will be performed through an online software at www.random.org, then will be stored in a stealth location. A blinded investigator will generate a numerical sequence of the randomized patients who meet the eligibility criteria. The study was not done with the total number of patients diagnosed with (COPD). Those divided into two groups: intervention and control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial, performed with two groups: intervention and controls (usual care).
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitationThe PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured. |
| Group control | No intervention | –The group will not receive pulmonary rehabilitation intervention. Patients will be guided and maintain their daily and routine lives normally during the evaluation process. However, a baseline evaluation will be performed, which will be repeated after 9 weeks: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes commonly used in the assistance to assess PR will also be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD;
- Stable patients (no exacerbation in the last 4 weeks).
Key exclusion criteria (6 listed)
- Patients with contraindications to exercise (decompensated ischemic heart disease or neuromuscular diseases) or unable to perform evaluations and / or participate in the pulmonary rehabilitation program.
- Bood pressure greater than 160/90 mmHg,
- Serum cholesterol greater than 220,
- Diabetes mellitus,
- Active smoking or using vasodilator drugs (calcium channel blockers and ACE inhibitors).
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 |
|---|---|---|
| Pulmonary rehabilitationThe PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured. | Other | Pulmonary rehabilitation |
Primary outcome
Dilatation mediated by the flow of the brachial artery
Time frame: Eight Weeks.
The flow-mediated dilatation of the brachial artery will be assessed non-invasively by the ultrasound device (SONOSITE®, M-Turbo, Sony). A high-frequency transducer (HFL38xp, SONOSITE®, Sony) will be used to obtain longitudinal images of the brachial artery walls.
16 secondary outcomes
Brachial ankle index
Time frame: Eight Weeks.
Body-mass Index
Time frame: Eight Weeks.
Airflow Obstruction
Time frame: Eight Weeks.
Dyspnea - Modified Medical Research Council (mMRC scale)
Time frame: Eight Weeks.
Exercise Capacity
Time frame: Eight Weeks.
Laboratory Tests - Total cholesterol
Time frame: Eight Weeks.
Laboratory Tests - HDL cholesterol
Time frame: Eight Weeks.
Laboratory Tests - LDL cholesterol
Time frame: Eight Weeks.
Laboratory Tests - Triglycerides
Time frame: Eight Weeks.
Laboratory Tests - C-reactive protein
Time frame: Eight Weeks.
Laboratory Tests - Glutamic oxaloacetic transaminase (GOT)
Time frame: Eight Weeks.
Laboratory Tests - Glutamic-pyruvic transaminase (GPT)
Time frame: Eight Weeks.
Laboratory Tests - Urea
Time frame: Eight Weeks.
Laboratory Tests - Creatinine
Time frame: Eight Weeks.
Anthropometric evaluation - Waist circumference
Time frame: Eight Weeks.
Anthropometric evaluation - Circumference of the hip
Time frame: Eight Weeks.
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 28 Jul 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.
Marli Knorst principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Hospital de Clinicas de Porto Alegre 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 6 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 28 Jul 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?
Dilatation mediated by the flow of the brachial artery (time frame: Eight Weeks.). 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 28 Jul 2023.