HypertensionHIGHCARE-LAPSNCT04751292
HIGH Altitude CArdiovascular REsearch Latin America Population Study
An observational study of Hypertension and Cardiovascular Risk Factor, run by Istituto Auxologico Italiano at 1 site in Peru.
Trial summary
High blood pressure (BP) is one of the principal cardiovascular risk factors. While BP levels and hypertension prevalence are well characterized in many populations, information on BP and on cardiovascular risk profile in high altitude inhabitants is limited and frequently contradictory, especially in the large… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factor, Altitude Hypoxia
- What is being tested?
- Exposure to high altitude
- How many people
- 937 participants
- Where
- 1 sitePeru
- Study dates
- 26 Jan 2021to 30 Dec 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: Study participants will be recruited by random sampling from the general population residing permanently in urban areas at: 1. Sea level (lowlanders): <500m altitude (the city of Lima and surroundings, population 7.605.742) 2. High altitude (highlanders): * 2500-3500 m (Cajamarca, 2,720 m, population 283.767; Cuzco, 3,399 m, pop. 420.137; Huancayo, 3.287m, pop. 501.384) * 3500-4000 m Juliaca, 3,824 m, pop. 216.716, * >4000 m (Ananea, 4.616m, pop. 20.572; La Rinconada 5.100m, pop. 50.000; Cerro de Pasco, 4.300-4.700 m, pop. 70.000)
Who may be able to join
- Adult (>18 years) male and female subjects;
- Highlanders: permanence at high (>2500 m) altitude;
- Lowlanders: permanence at low (<1500 m) altitude;
- Written informed consent to participate in the study
Who cannot join
- Lowlanders who over 3 months preceding inclusion in the study spent considerable (> 7 consecutive days) amount of time at altitudes above 1500 m;
- Highlanders who over 3 months preceding inclusion in the study spent considerable (>7 consecutive days) amount of time at altitudes below 2500 m;
- Subjects cognitively incapable of providing informed consent or responding to a questionnaire
- Physical disability that would prevent study assessments from being performed
- Active pulmonary tuberculosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
High blood pressure (BP) is one of the principal cardiovascular risk factors. While BP levels and hypertension prevalence are well characterized in many populations, information on BP and on cardiovascular risk profile in high altitude inhabitants is limited and frequently contradictory, especially in the large highland populations of South America. The information on the effects of permanent high altitude exposure on cardiovascular variables including BP may be relevant in the light of the known BP-increasing effect of acute exposure to high altitude hypoxia. This information may have practical implications for millions of people living at elevated altitudes in Asia, South America and Africa.
The inconclusive epidemiological evidence on BP and cardiovascular risk in high altitude dwellers may be the result of several factors, among them: 1) confounding by genetic and socio-economic factors; 2) imperfect methods of BP evaluation, in particular lack of data on ambulatory and home BP (both methods considered superior to conventional clinic BP in the assessment of exposure to high BP).
On this background, the general aim of the study is to compare blood pressure levels and cardiovascular risk profile among population-based samples of subjects residing in Peruvian communities living at different altitudes.
- Conditions
- Hypertension, Cardiovascular Risk Factor, Altitude Hypoxia, Altitude Sickness, Erythrocytosis, Sleep
- Being tested
- Exposure to high altitude
- Keywords
- ambulatory blood pressure monitoring, echocardiography
- Medical subject headings
- Hypertension, Altitude Sickness, Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to high altitudeOther
permanence at high (>2500 m) altitude; permanence is defined as being born and living at high altitude with the total time spent at lower altitudes not exceeding 2 years in the past 10 years
| Study group | Role | What they receive |
|---|---|---|
| Lowlanders | People living at low (<1500 m) altitude | |
| Highlanders | People living at high (>2500 m) altitude Receives: Other: Exposure to high altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.
Measured: baseline
Secondary outcomes (8)
Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders
Measured: baseline
Difference in conventional systolic and diastolic BP between lowlanders and highlanders
Measured: baseline
Difference in home systolic and diastolic BP between lowlanders and highlanders
Measured: baseline
Difference in sleep quality between lowlanders and highlanders
Pittsburgh questionnaire (score)
Measured: baseline
Difference in sleep duration between lowlanders and highlanders
self reported sleep duration (hours)
Measured: baseline
Difference in estimated cardiovascular risk
Measured: baseline
Difference between lowlanders and highlanders in hypertension prevalence
Measured: baseline
Difference in a number of BP variables between highlanders living at three high altitude levels
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start26 Jan 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, University of Milano Bicocca
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, Principal investigator, Istituto Auxologico ItalianoGrzegorz Bilo, PhD, Study director, Istituto Auxologico ItalianoFrancisco Villafuerte, PhD, Study director, Universidad Peruviana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751292
- Sponsor's protocol ID
- 09A921
- Acronym
- HIGHCARE-LAPS
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be placed in a public repository and available upon reasonable request after study completion
Publications
Bilo G, Acone L, Anza-Ramirez C, Macarlupu JL, Soranna D, Zambon A, Vizcardo-Galindo G, Pengo MF, Villafuerte FC, Parati G; HIGHCARE-ANDES Highlanders Study Investigators. Office and Ambulatory Arterial Hypertension in Highlanders: HIGHCARE-ANDES Highlanders Study. Hypertension. 2020 Dec;76(6):1962-1970. doi: 10.1161/HYPERTENSIONAHA.120.16010. Epub 2020 Nov 11.
PubMed 33175629Torlasco C, Bilo G, Giuliano A, Soranna D, Ravaro S, Oliverio G, Faini A, Zambon A, Lombardi C, Parati G. Effects of acute exposure to moderate altitude on blood pressure and sleep breathing patterns. Int J Cardiol. 2020 Feb 15;301:173-179. doi: 10.1016/j.ijcard.2019.09.034. Epub 2019 Oct 30.
PubMed 31780104Bilo G, Caravita S, Torlasco C, Parati G. Blood pressure at high altitude: physiology and clinical implications. Kardiol Pol. 2019 Jun 25;77(6):596-603. doi: 10.33963/KP.14832. Epub 2019 May 17.
PubMed 31099758Hainsworth R, Drinkhill MJ. Cardiovascular adjustments for life at high altitude. Respir Physiol Neurobiol. 2007 Sep 30;158(2-3):204-11. doi: 10.1016/j.resp.2007.05.006. Epub 2007 May 18.
PubMed 17597013Parati G, Agostoni P, Basnyat B, Bilo G, Brugger H, Coca A, Festi L, Giardini G, Lironcurti A, Luks AM, Maggiorini M, Modesti PA, Swenson ER, Williams B, Bartsch P, Torlasco C. Clinical recommendations for high altitude exposure of individuals with pre-existing cardiovascular conditions: A joint statement by the European Society of Cardiology, the Council on Hypertension of the European Society of Cardiology, the European Society of Hypertension, the International Society of Mountain Medicine, the Italian Society of Hypertension and the Italian Society of Mountain Medicine. Eur Heart J. 2018 May 1;39(17):1546-1554. doi: 10.1093/eurheartj/ehx720.
PubMed 29340578Duplain H, Vollenweider L, Delabays A, Nicod P, Bartsch P, Scherrer U. Augmented sympathetic activation during short-term hypoxia and high-altitude exposure in subjects susceptible to high-altitude pulmonary edema. Circulation. 1999 Apr 6;99(13):1713-8. doi: 10.1161/01.cir.99.13.1713.
PubMed 10190881Hansen J, Sander M. Sympathetic neural overactivity in healthy humans after prolonged exposure to hypobaric hypoxia. J Physiol. 2003 Feb 1;546(Pt 3):921-9. doi: 10.1113/jphysiol.2002.031765.
PubMed 12563015Bartsch P, Gibbs JS. Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. doi: 10.1161/CIRCULATIONAHA.106.650796. No abstract available.
PubMed 17984389Higgins JP, Tuttle T, Higgins JA. Altitude and the heart: is going high safe for your cardiac patient? Am Heart J. 2010 Jan;159(1):25-32. doi: 10.1016/j.ahj.2009.10.028.
PubMed 20102863Bilo G, Caldara G, Styczkiewicz K, Revera M, Lombardi C, Giglio A, Zambon A, Corrao G, Faini A, Valentini M, Mancia G, Parati G. Effects of selective and nonselective beta-blockade on 24-h ambulatory blood pressure under hypobaric hypoxia at altitude. J Hypertens. 2011 Feb;29(2):380-7. doi: 10.1097/HJH.0b013e3283409014.
PubMed 21045724Parati G, Bilo G, Faini A, Bilo B, Revera M, Giuliano A, Lombardi C, Caldara G, Gregorini F, Styczkiewicz K, Zambon A, Piperno A, Modesti PA, Agostoni P, Mancia G. Changes in 24 h ambulatory blood pressure and effects of angiotensin II receptor blockade during acute and prolonged high-altitude exposure: a randomized clinical trial. Eur Heart J. 2014 Nov 21;35(44):3113-22. doi: 10.1093/eurheartj/ehu275. Epub 2014 Aug 26.
PubMed 25161182Bilo G, Villafuerte FC, Faini A, Anza-Ramirez C, Revera M, Giuliano A, Caravita S, Gregorini F, Lombardi C, Salvioni E, Macarlupu JL, Ossoli D, Landaveri L, Lang M, Agostoni P, Sosa JM, Mancia G, Parati G. Ambulatory blood pressure in untreated and treated hypertensive patients at high altitude: the High Altitude Cardiovascular Research-Andes study. Hypertension. 2015 Jun;65(6):1266-72. doi: 10.1161/HYPERTENSIONAHA.114.05003. Epub 2015 Apr 20.
PubMed 25895588Savla JJ, Levine BD, Sadek HA. The Effect of Hypoxia on Cardiovascular Disease: Friend or Foe? High Alt Med Biol. 2018 Jun;19(2):124-130. doi: 10.1089/ham.2018.0044.
PubMed 29939783Aryal N, Weatherall M, Bhatta YK, Mann S. Blood Pressure and Hypertension in Adults Permanently Living at High Altitude: A Systematic Review and Meta-Analysis. High Alt Med Biol. 2016 Sep;17(3):185-193. doi: 10.1089/ham.2015.0118. Epub 2016 Aug 30.
PubMed 27575245Beall CM. Andean, Tibetan, and Ethiopian patterns of adaptation to high-altitude hypoxia. Integr Comp Biol. 2006 Feb;46(1):18-24. doi: 10.1093/icb/icj004. Epub 2006 Jan 6.
PubMed 21672719
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIGH Altitude CArdiovascular REsearch Latin America Population Study
- ClinicalTrials.gov ID
- NCT04751292
- Acronym / sponsor ID
- HIGHCARE-LAPS / 09A921
- Conditions
- Hypertension, Cardiovascular Risk Factor, Altitude Hypoxia, Altitude Sickness, Erythrocytosis, Sleep
- Keywords
- ambulatory blood pressure monitoring, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 937 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, University of Milano Bicocca
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 12 Feb 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.
High blood pressure (BP) is one of the principal cardiovascular risk factors. While BP levels and hypertension prevalence are well characterized in many populations, information on BP and on cardiovascular risk profile in high altitude inhabitants is limited and frequently contradictory, especially in the large highland populations of South America. The information on the effects of permanent high altitude exposure on cardiovascular variables including BP may be relevant in the light of the known BP-increasing effect of acute exposure to high altitude hypoxia. This information may have practical implications for millions of people living at elevated altitudes in Asia, South America and Africa.
The inconclusive epidemiological evidence on BP and cardiovascular risk in high altitude dwellers may be the result of several factors, among them: 1) confounding by genetic and socio-economic factors; 2) imperfect methods of BP evaluation, in particular lack of data on ambulatory and home BP (both methods considered superior to conventional clinic BP in the assessment of exposure to high BP).
On this background, the general aim of the study is to compare blood pressure levels and cardiovascular risk profile among population-based samples of subjects residing in Peruvian communities living at different altitudes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lowlanders | – | –People living at low (<1500 m) altitude |
| Highlanders | – | Other: Exposure to high altitudePeople living at high (>2500 m) altitude |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited by random sampling from the general population residing permanently in urban areas at: 1. Sea level (lowlanders): <500m altitude (the city of Lima and surroundings, population 7.605.742) 2. High altitude (highlanders): * 2500-3500 m (Cajamarca, 2,720 m, population 283.767; Cuzco, 3,399 m, pop. 420.137; Huancayo, 3.287m, pop. 501.384) * 3500-4000 m Juliaca, 3,824 m, pop. 216.716, * >4000 m (Ananea, 4.616m, pop. 20.572; La Rinconada 5.100m, pop. 50.000; Cerro de Pasco, 4.300-4.700 m, pop. 70.000)
Key inclusion criteria (4 listed)
- Adult (>18 years) male and female subjects;
- Highlanders: permanence at high (>2500 m) altitude;
- Lowlanders: permanence at low (<1500 m) altitude;
- Written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Lowlanders who over 3 months preceding inclusion in the study spent considerable (> 7 consecutive days) amount of time at altitudes above 1500 m;
- Highlanders who over 3 months preceding inclusion in the study spent considerable (>7 consecutive days) amount of time at altitudes below 2500 m;
- Subjects cognitively incapable of providing informed consent or responding to a questionnaire
- Physical disability that would prevent study assessments from being performed
- Active pulmonary tuberculosis
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 |
|---|---|---|
| Exposure to high altitudepermanence at high (>2500 m) altitude; permanence is defined as being born and living at high altitude with the total time spent at lower altitudes not exceeding 2 years in the past 10 years | Other | Highlanders |
Primary outcome
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.
Time frame: baseline
8 secondary outcomes
Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders
Time frame: baseline
Difference in conventional systolic and diastolic BP between lowlanders and highlanders
Time frame: baseline
Difference in home systolic and diastolic BP between lowlanders and highlanders
Time frame: baseline
Difference in sleep quality between lowlanders and highlanders
Time frame: baseline
Difference in sleep duration between lowlanders and highlanders
Time frame: baseline
Difference in estimated cardiovascular risk
Time frame: baseline
Difference between lowlanders and highlanders in hypertension prevalence
Time frame: baseline
Difference in a number of BP variables between highlanders living at three high altitude levels
Time frame: baseline
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 Mar 2024.
- Background: PubMed 33175629Bilo G, Acone L, Anza-Ramirez C, Macarlupu JL, Soranna D, Zambon A, Vizcardo-Galindo G, Pengo MF, Villafuerte FC, Parati G; HIGHCARE-ANDES Highlanders Study Investigators. Office and Ambulatory Arterial Hypertension in Highlanders: HIGHCARE-ANDES Highlanders Study. Hypertension. 2020 Dec;76(6):1962-1970. doi: 10.1161/HYPERTENSIONAHA.120.16010. Epub 2020 Nov 11.
- Background: PubMed 31780104Torlasco C, Bilo G, Giuliano A, Soranna D, Ravaro S, Oliverio G, Faini A, Zambon A, Lombardi C, Parati G. Effects of acute exposure to moderate altitude on blood pressure and sleep breathing patterns. Int J Cardiol. 2020 Feb 15;301:173-179. doi: 10.1016/j.ijcard.2019.09.034. Epub 2019 Oct 30.
- Background: PubMed 31099758Bilo G, Caravita S, Torlasco C, Parati G. Blood pressure at high altitude: physiology and clinical implications. Kardiol Pol. 2019 Jun 25;77(6):596-603. doi: 10.33963/KP.14832. Epub 2019 May 17.
- Background: PubMed 17597013Hainsworth R, Drinkhill MJ. Cardiovascular adjustments for life at high altitude. Respir Physiol Neurobiol. 2007 Sep 30;158(2-3):204-11. doi: 10.1016/j.resp.2007.05.006. Epub 2007 May 18.
- Background: PubMed 29340578Parati G, Agostoni P, Basnyat B, Bilo G, Brugger H, Coca A, Festi L, Giardini G, Lironcurti A, Luks AM, Maggiorini M, Modesti PA, Swenson ER, Williams B, Bartsch P, Torlasco C. Clinical recommendations for high altitude exposure of individuals with pre-existing cardiovascular conditions: A joint statement by the European Society of Cardiology, the Council on Hypertension of the European Society of Cardiology, the European Society of Hypertension, the International Society of Mountain Medicine, the Italian Society of Hypertension and the Italian Society of Mountain Medicine. Eur Heart J. 2018 May 1;39(17):1546-1554. doi: 10.1093/eurheartj/ehx720.
- Background: PubMed 10190881Duplain H, Vollenweider L, Delabays A, Nicod P, Bartsch P, Scherrer U. Augmented sympathetic activation during short-term hypoxia and high-altitude exposure in subjects susceptible to high-altitude pulmonary edema. Circulation. 1999 Apr 6;99(13):1713-8. doi: 10.1161/01.cir.99.13.1713.
- Background: PubMed 12563015Hansen J, Sander M. Sympathetic neural overactivity in healthy humans after prolonged exposure to hypobaric hypoxia. J Physiol. 2003 Feb 1;546(Pt 3):921-9. doi: 10.1113/jphysiol.2002.031765.
- Background: PubMed 17984389Bartsch P, Gibbs JS. Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. doi: 10.1161/CIRCULATIONAHA.106.650796. No abstract available.
- Background: PubMed 20102863Higgins JP, Tuttle T, Higgins JA. Altitude and the heart: is going high safe for your cardiac patient? Am Heart J. 2010 Jan;159(1):25-32. doi: 10.1016/j.ahj.2009.10.028.
- Background: PubMed 21045724Bilo G, Caldara G, Styczkiewicz K, Revera M, Lombardi C, Giglio A, Zambon A, Corrao G, Faini A, Valentini M, Mancia G, Parati G. Effects of selective and nonselective beta-blockade on 24-h ambulatory blood pressure under hypobaric hypoxia at altitude. J Hypertens. 2011 Feb;29(2):380-7. doi: 10.1097/HJH.0b013e3283409014.
- Background: PubMed 25161182Parati G, Bilo G, Faini A, Bilo B, Revera M, Giuliano A, Lombardi C, Caldara G, Gregorini F, Styczkiewicz K, Zambon A, Piperno A, Modesti PA, Agostoni P, Mancia G. Changes in 24 h ambulatory blood pressure and effects of angiotensin II receptor blockade during acute and prolonged high-altitude exposure: a randomized clinical trial. Eur Heart J. 2014 Nov 21;35(44):3113-22. doi: 10.1093/eurheartj/ehu275. Epub 2014 Aug 26.
- Background: PubMed 25895588Bilo G, Villafuerte FC, Faini A, Anza-Ramirez C, Revera M, Giuliano A, Caravita S, Gregorini F, Lombardi C, Salvioni E, Macarlupu JL, Ossoli D, Landaveri L, Lang M, Agostoni P, Sosa JM, Mancia G, Parati G. Ambulatory blood pressure in untreated and treated hypertensive patients at high altitude: the High Altitude Cardiovascular Research-Andes study. Hypertension. 2015 Jun;65(6):1266-72. doi: 10.1161/HYPERTENSIONAHA.114.05003. Epub 2015 Apr 20.
- Individual participant dataSharing planned: Yes. The data will be placed in a public repository and available upon reasonable request after study completion
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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.
Gianfranco Parati, MD principal investigator
Istituto Auxologico Italiano
Grzegorz Bilo, PhD study director
Istituto Auxologico Italiano
Francisco Villafuerte, PhD study director
Universidad Peruviana Cayetano Heredia
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 Hypertension and Cardiovascular Risk Factor, run by Istituto Auxologico Italiano at 1 site in Peru.
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 4 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 1 Mar 2024. 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 Peru. 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?
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders. (time frame: baseline). 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 NCT04751292, which also lists 20 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 1 Mar 2024.