Coronary DiseaseNCT03087292
Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
A study testing Resistance training with vascular occlusion in people with Coronary Disease and Coronary Artery Disease, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease
- What is being tested?
- Resistance training with vascular occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 27 Feb 2017to 15 Jun 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- above 18 years old and below 75 years old
- coronary heart disease documented with clinical event
- stable coronary heart disease patients
Who cannot join
- Unstable phase of coronary heart disease
- dysfunction of left ventricle
- residual myocardial ischemia
- contraindications for physical activity,
- intellectual development disorder,
- recent dissection of aorta
- recent vein thrombolysis
Trial locations and contacts
1 site in 1 country.
Borut Jug, PhD, MD contact
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre
Ljubljana, 1000
Borut Jug, PhD, MD, borut.jug@gmail.com
Tim Kambič, BSc, +386(0)40830858, tim.kambic@gmail.com
About this study
Official title: Effect of Low Intensity Resistance Training With Vascular Occlusion on Muscle Hypertrophy, Neuromuscular Adaptations and Selected Cardiovascular Parameters in Patients With Coronary Heart Disease
In our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).
Read the detailed description
Physical activity in patients with coronary heart disease improves health, quality of life, and reduces risk of coronary events, morbidity and mortality. Aerobic training is preferred as a part of cardiac rehabilitation with its well established evidence-based guidelines. On the other hand, the resistance training was first introduced as a part of cardiac rehabilitation just over a decade ago, due to its positive effects on performance, quality of life and muscle hypertrophy and strength. Despite the positive effects of resistance training, there still lacks evidence about its effect on cardiovascular health. Furthermore, guidelines still do not specify the exact training volumes, doses and types of resistance training for patients with coronary heart disease.
In clinical practice, it is often difficult and contraindicated to use near-maximal loads (e.g., in the early stages of cardiac rehabilitation, after sport injury, etc.). Muscle atrophy and weakness often occur rapidly in the affected area due to the effects of trauma (or disease) and inactivity. Consequently, training modalities that promote hypertrophy or counteract atrophy without the use of heavy loads should be of special interest in the rehabilitation of some chronic diseases for which high musculoskeletal forces are contraindicated.
Occlusive strength training with tourniquet cuffs was first used nearly twenty years ago. Studies have shown that low to-moderate intensity (20-50% of 1RM) resistance training with vascular occlusion leads to gains in muscle strength and volume comparable to those seen after conventional heavy resistance training. This effects suggest, that ischemic strength training may be a useful method in rehabilitation and other contexts.
To conclude, the aim of this study is to compare the effect of low intensity resistance training with vascular occlusion vs. normal physical activity on:
- muscle hypertrophy, strength and neuromuscular parameters;
- vascular function;
- and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)
- Conditions
- Coronary Disease, Coronary Artery Disease
- Being tested
- Resistance training with vascular occlusion
- Keywords
- blood flow restriction, resistance training, coronary heart disease
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training with vascular occlusionOther
Patients will perform unilateral leg extension resistance training with vascular occlusion 2 times per week for a period of 8 weeks. Each training session will consist of 3 sets of 15 repetitions at the intensity of 30% 1 RM with 30 s of rest period between sets.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training group | Active comparator | Patients to be randomly assigned to the "resistance training group" will have resistance training with vascular occlusion 2 times per week for a period of 8 weeks on unilateral leg extension machine. During each training, they will performed 3 sets of 15 repetitions at the intensity of 30% 1 RM (repetition maximum). Each training set will separated by a 30 second rest period. Receives: Other: Resistance training with vascular occlusion |
| Control group | No intervention | Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal strength
Determined with one repetition maximum test on leg extension machine (kg)
Measured: 4 weeks, 8 weeks
Secondary outcomes (16)
Change in maximal voluntary contraction (MVC)
Determined with modified interpolated twitch protocol
Measured: 4 and 8 weeks
Changes of flow-mediated dilatation of the brachial artery
Measured with ultrasound in %
Measured: 4 weeks, 8 weeks
Change in muscle hypertrophy (muscle thickness)
Measured with ultrasound in mm
Measured: 4 and 8 weeks
Change of the value of blood human growth hormon (HGH)
measured in ng/mL
Measured: 4 and 8 weeks
Change of the value of testosterone
measured in ng/dL
Measured: 4 and 8 weeks
Change of the value of myostatin
measured in ng/mL
Measured: 4 and 8 weeks
Change of the value of mechano growth factor (MGF)
measured in ng/mL
Measured: 4 and 8 weeks
Change of the value of insulin-like growth factor (IGF-1)
measured in ng/mL
Measured: 4 and 8 weeks
Change of the value of epinephrine
measured in pg/mL
Measured: 4 and 8 weeks
Change of the value of norepinephrine
measured in pg/mL
Measured: 4 and 8 weeks
Change of the value of cortisol
measured in mcg/dL
Measured: 4 and 8 weeks
Change in C-reactive protein
measured in mg/L
Measured: 4 and 8 weeks
Change in blood pressure prior and after exercise
measured in mmHg
Measured: 1-8 week
Change in heat-shock protein (HSP-72)
measured in ng/mL
Measured: 4 and 8 weeks
Change in resting and post-exercise heart rate
Measured in beats per min
Measured: 4 and 8 weeks
Change of from-the-questionnaire-obtained quality of life
Measured in points
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start27 Feb 2017
- Primary completion15 Jun 2017 (estimated)
- Study completion15 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Borut Jug, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087292
- Sponsor's protocol ID
- UKCLRehab022017
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nakajima, T., et al. Use and safety of KAATSU training: results of a national survey. Int J KAATSU Train Res; 2(1): 5-13, 2006.
Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.
PubMed 15668354Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
PubMed 16263889Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Pina IL, Stein RA, Williams M, Bazzarre T. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation. 2000 Feb 22;101(7):828-33. doi: 10.1161/01.cir.101.7.828. No abstract available.
PubMed 10683360Karabulut M, Abe T, Sato Y, Bemben MG. The effects of low-intensity resistance training with vascular restriction on leg muscle strength in older men. Eur J Appl Physiol. 2010 Jan;108(1):147-55. doi: 10.1007/s00421-009-1204-5. Epub 2009 Sep 18.
PubMed 19760431Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
PubMed 20150565Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
PubMed 21922259Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
PubMed 21735386Kambic T, Novakovic M, Tomazin K, Strojnik V, Bozic-Mijovski M, Jug B. Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. J Cardiovasc Nurs. 2021 Sep-Oct 01;36(5):507-516. doi: 10.1097/JCN.0000000000000699.
PubMed 32496365Kambic T, Novakovic M, Tomazin K, Strojnik V, Jug B. Blood Flow Restriction Resistance Exercise Improves Muscle Strength and Hemodynamics, but Not Vascular Function in Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial. Front Physiol. 2019 Jun 12;10:656. doi: 10.3389/fphys.2019.00656. eCollection 2019.
PubMed 31244668
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Intensity Resistance Training With Vascular Occlusion on Muscle Hypertrophy, Neuromuscular Adaptations and Selected Cardiovascular Parameters in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03087292
- Acronym / sponsor ID
- UKCLRehab022017
- Conditions
- Coronary Disease, Coronary Artery Disease
- Keywords
- blood flow restriction, resistance training, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 15 Jun 2017 (estimated)
- Study completion
- 15 Jun 2017 (estimated)
- First posted
- 22 Mar 2017 (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.
In our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).
Detailed description
Physical activity in patients with coronary heart disease improves health, quality of life, and reduces risk of coronary events, morbidity and mortality. Aerobic training is preferred as a part of cardiac rehabilitation with its well established evidence-based guidelines. On the other hand, the resistance training was first introduced as a part of cardiac rehabilitation just over a decade ago, due to its positive effects on performance, quality of life and muscle hypertrophy and strength. Despite the positive effects of resistance training, there still lacks evidence about its effect on cardiovascular health. Furthermore, guidelines still do not specify the exact training volumes, doses and types of resistance training for patients with coronary heart disease.
In clinical practice, it is often difficult and contraindicated to use near-maximal loads (e.g., in the early stages of cardiac rehabilitation, after sport injury, etc.). Muscle atrophy and weakness often occur rapidly in the affected area due to the effects of trauma (or disease) and inactivity. Consequently, training modalities that promote hypertrophy or counteract atrophy without the use of heavy loads should be of special interest in the rehabilitation of some chronic diseases for which high musculoskeletal forces are contraindicated.
Occlusive strength training with tourniquet cuffs was first used nearly twenty years ago. Studies have shown that low to-moderate intensity (20-50% of 1RM) resistance training with vascular occlusion leads to gains in muscle strength and volume comparable to those seen after conventional heavy resistance training. This effects suggest, that ischemic strength training may be a useful method in rehabilitation and other contexts.
To conclude, the aim of this study is to compare the effect of low intensity resistance training with vascular occlusion vs. normal physical activity on:
- muscle hypertrophy, strength and neuromuscular parameters;
- vascular function;
- and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training group | Active comparator | Other: Resistance training with vascular occlusionPatients to be randomly assigned to the "resistance training group" will have resistance training with vascular occlusion 2 times per week for a period of 8 weeks on unilateral leg extension machine. During each training, they will performed 3 sets of 15 repetitions at the intensity of 30% 1 RM (repetition maximum). Each training set will separated by a 30 second rest period. |
| Control group | No intervention | –Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- above 18 years old and below 75 years old
- coronary heart disease documented with clinical event
- stable coronary heart disease patients
Key exclusion criteria (7 listed)
- Unstable phase of coronary heart disease
- dysfunction of left ventricle
- residual myocardial ischemia
- contraindications for physical activity,
- intellectual development disorder,
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 |
|---|---|---|
| Resistance training with vascular occlusionPatients will perform unilateral leg extension resistance training with vascular occlusion 2 times per week for a period of 8 weeks. Each training session will consist of 3 sets of 15 repetitions at the intensity of 30% 1 RM with 30 s of rest period between sets. | Other | Resistance training group |
Primary outcome
Change in maximal strength
Time frame: 4 weeks, 8 weeks
Determined with one repetition maximum test on leg extension machine (kg)
16 secondary outcomes
Change in maximal voluntary contraction (MVC)
Time frame: 4 and 8 weeks
Changes of flow-mediated dilatation of the brachial artery
Time frame: 4 weeks, 8 weeks
Change in muscle hypertrophy (muscle thickness)
Time frame: 4 and 8 weeks
Change of the value of blood human growth hormon (HGH)
Time frame: 4 and 8 weeks
Change of the value of testosterone
Time frame: 4 and 8 weeks
Change of the value of myostatin
Time frame: 4 and 8 weeks
Change of the value of mechano growth factor (MGF)
Time frame: 4 and 8 weeks
Change of the value of insulin-like growth factor (IGF-1)
Time frame: 4 and 8 weeks
Change of the value of epinephrine
Time frame: 4 and 8 weeks
Change of the value of norepinephrine
Time frame: 4 and 8 weeks
Change of the value of cortisol
Time frame: 4 and 8 weeks
Change in C-reactive protein
Time frame: 4 and 8 weeks
Change in blood pressure prior and after exercise
Time frame: 1-8 week
Change in heat-shock protein (HSP-72)
Time frame: 4 and 8 weeks
Change in resting and post-exercise heart rate
Time frame: 4 and 8 weeks
Change of from-the-questionnaire-obtained quality of life
Time frame: 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- BackgroundNakajima, T., et al. Use and safety of KAATSU training: results of a national survey. Int J KAATSU Train Res; 2(1): 5-13, 2006.
- Background: PubMed 15668354Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.
- Background: PubMed 16263889Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
- Background: PubMed 10683360Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Pina IL, Stein RA, Williams M, Bazzarre T. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation. 2000 Feb 22;101(7):828-33. doi: 10.1161/01.cir.101.7.828. No abstract available.
- Background: PubMed 19760431Karabulut M, Abe T, Sato Y, Bemben MG. The effects of low-intensity resistance training with vascular restriction on leg muscle strength in older men. Eur J Appl Physiol. 2010 Jan;108(1):147-55. doi: 10.1007/s00421-009-1204-5. Epub 2009 Sep 18.
- Background: PubMed 20150565Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
- Background: PubMed 21922259Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
- Background: PubMed 21735386Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- Derived from this study: PubMed 32496365Kambic T, Novakovic M, Tomazin K, Strojnik V, Bozic-Mijovski M, Jug B. Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. J Cardiovasc Nurs. 2021 Sep-Oct 01;36(5):507-516. doi: 10.1097/JCN.0000000000000699.
- Derived from this study: PubMed 31244668Kambic T, Novakovic M, Tomazin K, Strojnik V, Jug B. Blood Flow Restriction Resistance Exercise Improves Muscle Strength and Hemodynamics, but Not Vascular Function in Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial. Front Physiol. 2019 Jun 12;10:656. doi: 10.3389/fphys.2019.00656. eCollection 2019.
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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.
Borut Jug, PhD, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training with vascular occlusion in people with Coronary Disease and Coronary Artery Disease, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Mar 2017. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim Kambič, BSc (+386 (0)40830858, tim.kambic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal strength (time frame: 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087292, which also lists 10 linked publications.
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 27 Mar 2017.