Hamburg City Health Study - a German Cohort Study (HCHS)

• ClinicalTrials.gov Identifier: NCT03934957
• Recruitment Status: Recruiting
• First Posted: May 2, 2019
• Last Update Posted: May 2, 2019
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Universitäres Herzzentrum Hamburg-Eppendorf; Martini-Klinik am UKE GmbH
• Information provided by (Responsible Party): Universitätsklinikum Hamburg-Eppendorf

Tracking Information

• First Submitted Date: January 4, 2019
• First Posted Date: May 2, 2019
• Last Update Posted Date: May 2, 2019
• Actual Study Start Date: February 8, 2016
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hamburg City Health Study - a German Cohort 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
• Brief 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

serum, plasma (EDTA, citrate), genomic deoxyribonucleic acid (DNA), ribonucleic acid (RNA) from whole blood and peripheral blood mononuclear cells (PBMCs), blood cells (erythrocytes, PBMCs), urine, saliva, tooth fluid, tonsils swabs

• Sampling Method: Probability Sample
• 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.

Condition

• Coronary Heart Disease
• Stroke
• Dementia
• Cancer
• Health Care
• Vascular Diseases
• Periodontal Diseases
• Ocular Diseases
• Respiratory Disease
• Obesity

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Cavus 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.
• Zyriax 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.
• Jacobi N, Walther C, Borof K, Heydecke G, Seedorf U, Lamprecht R, Beikler T, Debus SE, Waldeyer C, Blankenberg S, Schnabel RB, Aarabi G, Behrendt CA. The Association of Periodontitis and Peripheral Arterial Occlusive Disease in a Prospective Population-Based Cross-Sectional Cohort Study. J Clin Med. 2021 May 11;10(10):2048. doi: 10.3390/jcm10102048.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 28, 2019): 45000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2028
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Annika Jagodzinski, MD; 0049741059328; A.Jagodzinski@uke.de

Contact: Tanja Zeller, Professor; 0049741056045; t.zeller@uke.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03934957
• Other Study ID Numbers: PV5131
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• Original Responsible Party: Same as current
• Current Study Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Original Study Sponsor: Same as current

Collaborators

• Universitäres Herzzentrum Hamburg-Eppendorf
• Martini-Klinik am UKE GmbH

Investigators

• Principal Investigator: Stefan Blankenberg, Professor; Universitäres Herzzentrum Hamburg

• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: April 2019