Coronary Heart DiseaseHCHSNCT03934957
Hamburg City Health Study - a German Cohort Study
An observational study of Coronary Heart Disease and Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Stroke, Dementia
- How many people
- 45,000 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2016to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population based cohort, participants are identified by a random sample from the official inhabitant data file divided into gender and six age strata.
Who may be able to join
- Inhabitant of the city of Hamburg at the time of inclusion into the study (Inclusion is time of written consent)
- Age 45 to 74 years
- Personally signed informed consent
Who cannot join
- Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation
- Physical or psychological incapability to travel to the study center and to cooperate in the investigations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Susannw Bruder, 00494056045, s.bruder@uke.de
About this study
Official title: A Single Center, Prospective, Epidemiologic Cohort Study With Emphasis on Imaging to Improve the Identification of Individuals at Risk for Major Chronic Diseases and to Improve Early Diagnosis and Survival
The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.
Read the detailed description
A random sample of 45.000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, will take part in an extensive baseline assessment at a dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations. The protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional MRI examination either of heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.
- Conditions
- Coronary Heart Disease, Stroke, Dementia, Cancer, Health Care, Vascular Diseases
- Keywords
- Epidemiology, prospective cohort study, Nutrition, prevention, psychiatric and psychosomatic disorders
- Medical subject headings
- Coronary Disease, Stroke, Dementia, Neoplasms, Vascular Diseases, Periodontal Diseases, Respiration Disorders, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported Information on changes in health in the participants
coronary artery disease atrial fibrillation heart failure dementia stroke cancer such as prostate cancer and skin cancer chronic kidney diseases migraine musculoskeletal diseases such as osteoporosis and bone metastasis ocular diseases such as glaucoma, macular degeneration, fundus hypertonicus, retinal vessel disease and neoplasm oral health including periodontal disease, oropharyngeal cancer and human papillomavirus (HPV)-infection psychiatric and psychosomatic disorders such as mental disorder or late - last depression pulmonary diseases such as obstructive lung disease sexual disorder skin diseases such as psoriasis, chronic wounds and inflammation vascular diseases such as aortic aneurysm, thrombosis and peripheral arterial disease
Measured: yearly up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start8 Feb 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 45,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, Martini-Klinik am UKE GmbH
- Responsible party
- Sponsor
- Investigators
- Stefan Blankenberg, Professor, Principal investigator, Universitäres Herzzentrum Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934957
- Sponsor's protocol ID
- PV5131
- Acronym
- HCHS
- Status last verified
- Apr 2019
- First submitted
- 4 Jan 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schellin J, Sehner S, Neumann M, Petersen M, Nagele FL, Singh SD, Rosand J, Schumacher N, Zyriax BC, Twerenbold R, Cheng B, Thomalla G, Jensen M. Associations Between the Brain Care Score and Structural Brain Changes and Cognitive Impairment Using Data From the Hamburg City Health Study. Eur J Neurol. 2026 Oct;33(10):e70796. doi: 10.1111/ene.70796.
PubMed 42922092Riedl KA, Reuter K, Bottcher A, Hullebrand M, Hennemuth A, Cavus E, Braren R, Kirchhof P, Blankenberg S, Betz CS, Lund G, Muellerleile K, Hoffmann AS. CMR-based aortic stiffness parameters in a symptomatic high risk obstructive sleep apnea cohort: results from the population-based Hamburg City Health Study. BMC Cardiovasc Disord. 2026 Aug 13;26(1):691. doi: 10.1186/s12872-026-06450-z.
PubMed 42587278Koch LR, Becker S, Bosnjak A, Biedermann M, Jadidi AS, Westermann D, Lehrmann H, Loewe A, Arentz T, Schell M, Thomalla G, Engler D, Schnabel RB, Eichenlaub M. Amplified P-wave duration predicts incident atrial fibrillation in the general population: Results from the Hamburg City Health Study. Heart Rhythm O2. 2026 Apr 2;7(7):1242-1249. doi: 10.1016/j.hroo.2026.03.033. eCollection 2026 Jul.
PubMed 42488147Schmidt-Lauber C, Ebinghaus M, Borof K, Lieske B, Klopp A, Thompson C, Wees L, Dawood Z, Heydecke G, Beikler T, Huber TB, Aarabi G. Association of periodontitis with reduced kidney function and albuminuria in early chronic kidney disease: a population-based study. Int J Oral Sci. 2026 Apr 6;18(1):33. doi: 10.1038/s41368-026-00435-6.
PubMed 41936582Jessen B, Lowe B, Twerenbold R, Harter M, Harth V, Hoven H, Schmidt-Lauber C, Huber TB, Shedden-Mora M. Biopsychosocial Correlates of Somatic Symptom Burden in CKD: Results of the Hamburg City Health Study. Kidney360. 2026 May 1;7(5):1065-1075. doi: 10.34067/KID.0000001130. Epub 2026 Jan 30.
PubMed 41615722Jensen M, Vettorazzi E, Weber P, Petersen M, Schell M, Nagele FL, Link MA, Schlemm E, Rimmele DL, Becher PM, Cheng B, Blankenberg S, Kirchhof P, Zeller T, Twerenbold R, Thomalla G. Association of Cardiac Biomarkers With Structural Brain Changes and Cognitive Impairment: Results From the Hamburg City Health Study. Neurology. 2025 Aug 12;105(3):e213865. doi: 10.1212/WNL.0000000000213865. Epub 2025 Jul 3.
PubMed 40609062Riccio C, Arnold N, Koliopanos G, Link V, Guo L, Betschart RO, Zeller T, Blankenberg S, Ziegler A, Twerenbold R. Familial Hypercholesterolemia: Prevalence and Discrepancy between Genotype and Phenotype. Findings of the Population-based Hamburg City Health Study. Dtsch Arztebl Int. 2025 Sep 19;122(19):511-516. doi: 10.3238/arztebl.m2025.0110.
PubMed 40560421Wenzel JP, Albrecht JN, Toprak B, Petersen E, Nikorowitsch J, Cavus E, Jahnke C, Riedl KA, Adam G, Twerenbold R, Blankenberg S, Kirchhof P, Lund G, Tahir E, Mullerleile K, Radunski UK. Head-to-head comparison of cardiac magnetic resonance imaging and transthoracic echocardiography in the general population (MATCH). Clin Res Cardiol. 2025 May 12. doi: 10.1007/s00392-025-02660-1. Online ahead of print.
PubMed 40353872Rimmele DL, Petersen EL, Affolderbach S, Petersen M, Cheng B, Mayer C, Nagele FL, Harth V, Terschuren C, Kuhn S, Zeller T, Gerloff C, Thomalla G. Differences in impact of current and former shift work on cardiovascular risk factors, carotid atherosclerosis, and white matter integrity. Sleep Adv. 2024 Jul 31;5(1):zpae056. doi: 10.1093/sleepadvances/zpae056. eCollection 2024.
PubMed 39156216Cavus E, Schneider JN, di Carluccio E, Ziegler A, Haack A, Ojeda F, Chevalier C, Jahnke C, Riedl KA, Radunski UK, Twerenbold R, Kirchhof P, Blankenberg S, Adam G, Tahir E, Lund GK, Muellerleile K. Unrecognized myocardial scar by late-gadolinium-enhancement cardiovascular magnetic resonance: Insights from the population-based Hamburg City Health Study. J Cardiovasc Magn Reson. 2024 Summer;26(1):101008. doi: 10.1016/j.jocmr.2024.101008. Epub 2024 Feb 9.
PubMed 38341145Rimmele DL, Borof K, Wenzel JP, Jensen M, Behrendt CA, Waldeyer C, Schnabel RB, Zeller T, Debus ES, Blankenberg S, Gerloff C, Thomalla G. Differential association of flow velocities in the carotid artery with plaques, intima media thickness and cardiac function. Atheroscler Plus. 2021 Jul 31;43:18-23. doi: 10.1016/j.athplu.2021.07.020. eCollection 2021 Sep.
PubMed 36644504Cavus E, Schneider JN, Bei der Kellen R, di Carluccio E, Ziegler A, Tahir E, Bohnen S, Avanesov M, Radunski UK, Chevalier C, Jahnke C, Ojeda F, Kirchhof P, Blankenberg S, Adam G, Lund GK, Muellerleile K. Impact of Sex and Cardiovascular Risk Factors on Myocardial T1, Extracellular Volume Fraction, and T2 at 3 Tesla: Results From the Population-Based, Hamburg City Health Study. Circ Cardiovasc Imaging. 2022 Sep;15(9):e014158. doi: 10.1161/CIRCIMAGING.122.014158. Epub 2022 Sep 20.
PubMed 36126126Rimmele DL, Petersen EL, Schlemm E, Kessner SS, Petersen M, Mayer C, Cheng B, Zeller T, Waldeyer C, Behrendt CA, Gerloff C, Thomalla G. Association of Carotid Plaque and Flow Velocity With White Matter Integrity in a Middle-aged to Elderly Population. Neurology. 2022 Dec 12;99(24):e2699-e2707. doi: 10.1212/WNL.0000000000201297.
PubMed 36123124Walther C, Spinler K, Borof K, Kofahl C, Heydecke G, Seedorf U, Beikler T, Terschuren C, Hajek A, Aarabi G. Evidence from the Hamburg City Health Study - association between education and periodontitis. BMC Public Health. 2022 Sep 2;22(1):1662. doi: 10.1186/s12889-022-14096-7.
PubMed 36056348Zyriax BC, Borof K, Walter S, Augustin M, Windler E. Knowledge as to cholesterol reduction and use of phytosterol-enriched dietary foods in the general population: Insights from the Hamburg City Health Study. Atherosclerosis. 2022 Jan;341:1-6. doi: 10.1016/j.atherosclerosis.2021.12.004. Epub 2021 Dec 12.
PubMed 34922192
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Epidemiologic Cohort Study With Emphasis on Imaging to Improve the Identification of Individuals at Risk for Major Chronic Diseases and to Improve Early Diagnosis and Survival
- ClinicalTrials.gov ID
- NCT03934957
- Acronym / sponsor ID
- HCHS / PV5131
- Conditions
- Coronary Heart Disease, Stroke, Dementia, Cancer, Health Care, Vascular Diseases
- Keywords
- Epidemiology, prospective cohort study, Nutrition, prevention, psychiatric and psychosomatic disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, Martini-Klinik am UKE GmbH
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 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.
The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.
Detailed description
A random sample of 45.000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, will take part in an extensive baseline assessment at a dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations. The protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional MRI examination either of heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population based cohort, participants are identified by a random sample from the official inhabitant data file divided into gender and six age strata.
Key inclusion criteria (3 listed)
- Inhabitant of the city of Hamburg at the time of inclusion into the study (Inclusion is time of written consent)
- Age 45 to 74 years
- Personally signed informed consent
Key exclusion criteria (2 listed)
- Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation
- Physical or psychological incapability to travel to the study center and to cooperate in the investigations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
self-reported Information on changes in health in the participants
Time frame: yearly up to 12 years
coronary artery disease atrial fibrillation heart failure dementia stroke cancer such as prostate cancer and skin cancer chronic kidney diseases migraine musculoskeletal diseases such as osteoporosis and bone metastasis ocular diseases such as glaucoma, macular degeneration, fundus hypertonicus, retinal vessel disease and neoplasm oral health including periodontal disease, oropharyngeal cancer and human papillomavirus (HPV)-infection psychiatric and psychosomatic disorders such as mental disorder or late - last depression pulmonary diseases such as obstructive lung disease sexual disorder skin diseases such as psoriasis, chronic wounds and inflammation vascular diseases such as aortic aneurysm, thrombosis and peripheral arterial disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 42922092Schellin J, Sehner S, Neumann M, Petersen M, Nagele FL, Singh SD, Rosand J, Schumacher N, Zyriax BC, Twerenbold R, Cheng B, Thomalla G, Jensen M. Associations Between the Brain Care Score and Structural Brain Changes and Cognitive Impairment Using Data From the Hamburg City Health Study. Eur J Neurol. 2026 Oct;33(10):e70796. doi: 10.1111/ene.70796.
- Derived from this study: PubMed 42587278Riedl KA, Reuter K, Bottcher A, Hullebrand M, Hennemuth A, Cavus E, Braren R, Kirchhof P, Blankenberg S, Betz CS, Lund G, Muellerleile K, Hoffmann AS. CMR-based aortic stiffness parameters in a symptomatic high risk obstructive sleep apnea cohort: results from the population-based Hamburg City Health Study. BMC Cardiovasc Disord. 2026 Aug 13;26(1):691. doi: 10.1186/s12872-026-06450-z.
- Derived from this study: PubMed 42488147Koch LR, Becker S, Bosnjak A, Biedermann M, Jadidi AS, Westermann D, Lehrmann H, Loewe A, Arentz T, Schell M, Thomalla G, Engler D, Schnabel RB, Eichenlaub M. Amplified P-wave duration predicts incident atrial fibrillation in the general population: Results from the Hamburg City Health Study. Heart Rhythm O2. 2026 Apr 2;7(7):1242-1249. doi: 10.1016/j.hroo.2026.03.033. eCollection 2026 Jul.
- Derived from this study: PubMed 41936582Schmidt-Lauber C, Ebinghaus M, Borof K, Lieske B, Klopp A, Thompson C, Wees L, Dawood Z, Heydecke G, Beikler T, Huber TB, Aarabi G. Association of periodontitis with reduced kidney function and albuminuria in early chronic kidney disease: a population-based study. Int J Oral Sci. 2026 Apr 6;18(1):33. doi: 10.1038/s41368-026-00435-6.
- Derived from this study: PubMed 41615722Jessen B, Lowe B, Twerenbold R, Harter M, Harth V, Hoven H, Schmidt-Lauber C, Huber TB, Shedden-Mora M. Biopsychosocial Correlates of Somatic Symptom Burden in CKD: Results of the Hamburg City Health Study. Kidney360. 2026 May 1;7(5):1065-1075. doi: 10.34067/KID.0000001130. Epub 2026 Jan 30.
- Derived from this study: PubMed 40609062Jensen M, Vettorazzi E, Weber P, Petersen M, Schell M, Nagele FL, Link MA, Schlemm E, Rimmele DL, Becher PM, Cheng B, Blankenberg S, Kirchhof P, Zeller T, Twerenbold R, Thomalla G. Association of Cardiac Biomarkers With Structural Brain Changes and Cognitive Impairment: Results From the Hamburg City Health Study. Neurology. 2025 Aug 12;105(3):e213865. doi: 10.1212/WNL.0000000000213865. Epub 2025 Jul 3.
- Derived from this study: PubMed 40560421Riccio C, Arnold N, Koliopanos G, Link V, Guo L, Betschart RO, Zeller T, Blankenberg S, Ziegler A, Twerenbold R. Familial Hypercholesterolemia: Prevalence and Discrepancy between Genotype and Phenotype. Findings of the Population-based Hamburg City Health Study. Dtsch Arztebl Int. 2025 Sep 19;122(19):511-516. doi: 10.3238/arztebl.m2025.0110.
- Derived from this study: PubMed 40353872Wenzel JP, Albrecht JN, Toprak B, Petersen E, Nikorowitsch J, Cavus E, Jahnke C, Riedl KA, Adam G, Twerenbold R, Blankenberg S, Kirchhof P, Lund G, Tahir E, Mullerleile K, Radunski UK. Head-to-head comparison of cardiac magnetic resonance imaging and transthoracic echocardiography in the general population (MATCH). Clin Res Cardiol. 2025 May 12. doi: 10.1007/s00392-025-02660-1. Online ahead of print.
- Derived from this study: PubMed 39156216Rimmele DL, Petersen EL, Affolderbach S, Petersen M, Cheng B, Mayer C, Nagele FL, Harth V, Terschuren C, Kuhn S, Zeller T, Gerloff C, Thomalla G. Differences in impact of current and former shift work on cardiovascular risk factors, carotid atherosclerosis, and white matter integrity. Sleep Adv. 2024 Jul 31;5(1):zpae056. doi: 10.1093/sleepadvances/zpae056. eCollection 2024.
- Derived from this study: PubMed 38341145Cavus E, Schneider JN, di Carluccio E, Ziegler A, Haack A, Ojeda F, Chevalier C, Jahnke C, Riedl KA, Radunski UK, Twerenbold R, Kirchhof P, Blankenberg S, Adam G, Tahir E, Lund GK, Muellerleile K. Unrecognized myocardial scar by late-gadolinium-enhancement cardiovascular magnetic resonance: Insights from the population-based Hamburg City Health Study. J Cardiovasc Magn Reson. 2024 Summer;26(1):101008. doi: 10.1016/j.jocmr.2024.101008. Epub 2024 Feb 9.
- Derived from this study: PubMed 36644504Rimmele DL, Borof K, Wenzel JP, Jensen M, Behrendt CA, Waldeyer C, Schnabel RB, Zeller T, Debus ES, Blankenberg S, Gerloff C, Thomalla G. Differential association of flow velocities in the carotid artery with plaques, intima media thickness and cardiac function. Atheroscler Plus. 2021 Jul 31;43:18-23. doi: 10.1016/j.athplu.2021.07.020. eCollection 2021 Sep.
- Derived from this study: PubMed 36126126Cavus E, Schneider JN, Bei der Kellen R, di Carluccio E, Ziegler A, Tahir E, Bohnen S, Avanesov M, Radunski UK, Chevalier C, Jahnke C, Ojeda F, Kirchhof P, Blankenberg S, Adam G, Lund GK, Muellerleile K. Impact of Sex and Cardiovascular Risk Factors on Myocardial T1, Extracellular Volume Fraction, and T2 at 3 Tesla: Results From the Population-Based, Hamburg City Health Study. Circ Cardiovasc Imaging. 2022 Sep;15(9):e014158. doi: 10.1161/CIRCIMAGING.122.014158. Epub 2022 Sep 20.
- 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.
Stefan Blankenberg, Professor principal investigator
Universitäres Herzzentrum Hamburg
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 Coronary Heart Disease and Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 2 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: looking for participants now, as of the sponsor's last update on 2 May 2019. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annika Jagodzinski, MD (0049741059328, A.Jagodzinski@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported Information on changes in health in the participants (time frame: yearly up to 12 years). 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 NCT03934957, which also lists 16 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 2 May 2019.