All-cause MortalityNCT05466825
The Global Cardiovascular Risk Consortium
An observational study of All-cause Mortality and Cardiovascular Disease, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The Global Cardiovascular Risk Consortium (GCVRC) brings together harmonized individual-level data from currently more than 2 million (anticipated: approximately 3 million) individuals across 133 cohorts, 40 countries, and 6 continents, with recruitment ongoing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- All-cause Mortality, Cardiovascular Disease
- How many people
- 3,000,000 participants
- Where
- 1 siteGermany
- Study dates
- 20 Sep 2019to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The GCVRC uses harmonized individual-level data from currently more than 2 Mio individuals from 133 cohorts, 40 countries and 6 continents, categorized in 8 geographical regions - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Australia. The database provides information on cardiovascular risk factors, including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as data on major cardiovascular outcomes and death.
Who may be able to join
- Population-based individual-level data with available information on the classical cardiovascular risk factors including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as the outcomes of interest.
Who cannot join
- Participants with age below 18 years
- No information on the outcome of interest
- No information on the exposure of interest (CVD risk factors)
- History of CVD at baseline
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
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Prof. Dr. med. Stefan Blankenberg, +49 (0)40 741056800, s.blankenberg@uke.de
Prof. Dr. med. Christina Magnussen, +49 (0)40 741058206, c.magnussen@uke.de
About this study
Official title: Predicting Cardiovascular Risk by Geographical Region and Sex Using Classical Cardiovascular Risk Factors
The Global Cardiovascular Risk Consortium (GCVRC) brings together harmonized individual-level data from currently more than 2 million (anticipated: approximately 3 million) individuals across 133 cohorts, 40 countries, and 6 continents, with recruitment ongoing. The GCVRC examines the impact of classical cardiovascular risk factors-such as body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes-on cardiovascular disease (CVD) and death from any cause worldwide.
Read the detailed description
A small number of modifiable risk factors accounts for a significant proportion of cardiovascular disease (CVD) risk. However, the CVD burden attributable to classical risk factors depends on the populations studied and the methodologies used.
The Global Cardiovascular Risk Consortium (GCVRC) is an international collaboration that continuously includes cohort studies from around the world to improve cardiovascular risk prediction. The GCVRC uses extensively harmonized individual-level data from currently more than 2 million individuals from 133 cohorts, 40 countries and 6 continents categorized in 8 geographical regions (based on a modification of WHO and United Nations definitions) - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Australia.
The consortium has a special focus on classical, potentially modifiable cardiovascular risk factors: body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes. Key research questions include examining the impact of these factors on major outcomes by geographical region and sex, as well as estimating associated lifetime risk and the potential lifetime difference when modifying these risk factors.
This work is critical for developing regionally tailored CVD prevention and treatment strategies, identifying residual risk, and improving global cardiovascular health.
Based on GCVRC data, a paper on the effect of classical risk factors on new-onset CVD and all-cause mortality was published in the New England Journal of Medicine in 2023 (doi.org/10.1056/nejmoa2206916), followed by a study evaluating the effect of classical risk factors on different lifetime estimates, also published in the New England Journal of Medicine in 2025 (doi: 10.1056/NEJMoa2415879).
Further studies evaluate the effect of projecting risk factor reductions on CVD and all-cause mortality at the population level.
- Conditions
- All-cause Mortality, Cardiovascular Disease
- Keywords
- Cardiovascular Disease, Cardiovascular Risk Factors, Risk Factor Modification, Global, Lifetime Gain, Lifetime estimates, Projected risk reductions, Lifetime difference, Implementation strategies
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease (CVD)
Event rates of CVD and CVD subtypes: First fatal or non-fatal myocardial infarction, unstable angina, coronary revascularization, ischemic or hemorrhagic stroke, and cardiovascular or unclassifiable death. The type of outcome measurement varies across cohorts. CVD cases and subtypes are assessed by questionnaire information, national hospital discharge registry data, causes of death registry data or central death registries depending on the study protocol of the respective cohort studies.
Measured: Median follow-up of 7-10 years
Death from any cause
Number of deaths from any cause.
Measured: Median follow-up of 7-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start20 Sep 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for All-cause MortalityStudies 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
- 3,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Stefan Blankenberg, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Prof. Dr. med. Stefan Blankenberg, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466825
- Sponsor's protocol ID
- GCVRC001
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Global Cardiovascular Risk Consortium; Magnussen C, Alegre-Diaz J, Al-Nasser LA, Amouyel P, Aviles-Santa L, Bakker SJL, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Boffetta P, Brenner H, Brunstrom M, Can G, Carrillo-Larco RM, Checkley W, Dallongeville J, De Bacquer D, de Gaetano G, de Lemos JA, di Carluccio E, Dobson A, Donfrancesco C, Dorr M, d'Orsi E, Drygas W, Dullaart RPF, Engstrom G, Ferrario MM, Ferrieres J, Figtree GA, Gaye B, Ghayour-Mobarhan M, Goldbourt U, Gonzalez C, Gossling A, Grassi G, Gupta PC, He J, Hodge AM, Hozawa A, Hveem K, Iacoviello L, Ikram MK, Inoue M, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Klotsche J, Koenig W, Kontsevaya A, Kowlessur S, Kuri-Morales P, Kuulasmaa K, Kweon SS, Lackner KJ, Landmesser U, Leistner DM, Leiva Sisnieguez CE, Leong D, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, McElduff P, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Munzinger J, Nalini M, Nambi V, Nilsson PM, Ninomiya T, Omland T, Ong SK, Oppermann K, Pajak A, Palmieri L, Panagiotakos D, Park SK, Pednekar MS, Perianayagam A, Peters A, Poustchi H, Prabhakaran D, Prentice AM, Prescott E, Quyyumi A, Riserus U, Sakata S, Salazar M, Salomaa V, Sans S, Sattler ELP, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw J, Simons LA, Soderberg S, Tamosiunas A, Tapia-Conyer R, Thorand B, Tunstall-Pedoe H, Tuomilehto J, Twerenbold R, Vanuzzo D, Veronesi G, Wannamethee SG, Watanabe M, Weimann J, Wild PS, Yao Y, Zeng Y, Ziegler A, Ojeda FM, Blankenberg S; The Global Cardiovascular Risk Consortium. Global Effect of Cardiovascular Risk Factors on Lifetime Estimates. N Engl J Med. 2025 Jul 10;393(2):125-138. doi: 10.1056/NEJMoa2415879. Epub 2025 Mar 30.
PubMed 40162648Global Cardiovascular Risk Consortium; Magnussen C, Ojeda FM, Leong DP, Alegre-Diaz J, Amouyel P, Aviles-Santa L, De Bacquer D, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Brenner H, Carrillo-Larco RM, de Lemos J, Dobson A, Dorr M, Donfrancesco C, Drygas W, Dullaart RP, Engstrom G, Ferrario MM, Ferrieres J, de Gaetano G, Goldbourt U, Gonzalez C, Grassi G, Hodge AM, Hveem K, Iacoviello L, Ikram MK, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Koenig W, Kontsevaya A, Kuulasmaa K, Lackner KJ, Leistner DM, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Nalini M, Nambi V, Ninomiya T, Oppermann K, d'Orsi E, Pajak A, Palmieri L, Panagiotakos D, Perianayagam A, Peters A, Poustchi H, Prentice AM, Prescott E, Riserus U, Salomaa V, Sans S, Sakata S, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw JE, Simons LA, Soderberg S, Tamosiunas A, Thorand B, Tunstall-Pedoe H, Twerenbold R, Vanuzzo D, Veronesi G, Waibel J, Wannamethee SG, Watanabe M, Wild PS, Yao Y, Zeng Y, Ziegler A, Blankenberg S. Global Effect of Modifiable Risk Factors on Cardiovascular Disease and Mortality. N Engl J Med. 2023 Oct 5;389(14):1273-1285. doi: 10.1056/NEJMoa2206916. Epub 2023 Aug 26.
PubMed 37632466
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Cardiovascular Risk by Geographical Region and Sex Using Classical Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT05466825
- Acronym / sponsor ID
- GCVRC001
- Conditions
- All-cause Mortality, Cardiovascular Disease
- Keywords
- Cardiovascular Disease, Cardiovascular Risk Factors, Risk Factor Modification, Global, Lifetime Gain, Lifetime estimates, Projected risk reductions, Lifetime difference
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Jul 2022 (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 Global Cardiovascular Risk Consortium (GCVRC) brings together harmonized individual-level data from currently more than 2 million (anticipated: approximately 3 million) individuals across 133 cohorts, 40 countries, and 6 continents, with recruitment ongoing. The GCVRC examines the impact of classical cardiovascular risk factors-such as body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes-on cardiovascular disease (CVD) and death from any cause worldwide.
Detailed description
A small number of modifiable risk factors accounts for a significant proportion of cardiovascular disease (CVD) risk. However, the CVD burden attributable to classical risk factors depends on the populations studied and the methodologies used.
The Global Cardiovascular Risk Consortium (GCVRC) is an international collaboration that continuously includes cohort studies from around the world to improve cardiovascular risk prediction. The GCVRC uses extensively harmonized individual-level data from currently more than 2 million individuals from 133 cohorts, 40 countries and 6 continents categorized in 8 geographical regions (based on a modification of WHO and United Nations definitions) - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Australia.
The consortium has a special focus on classical, potentially modifiable cardiovascular risk factors: body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes. Key research questions include examining the impact of these factors on major outcomes by geographical region and sex, as well as estimating associated lifetime risk and the potential lifetime difference when modifying these risk factors.
This work is critical for developing regionally tailored CVD prevention and treatment strategies, identifying residual risk, and improving global cardiovascular health.
Based on GCVRC data, a paper on the effect of classical risk factors on new-onset CVD and all-cause mortality was published in the New England Journal of Medicine in 2023 (doi.org/10.1056/nejmoa2206916), followed by a study evaluating the effect of classical risk factors on different lifetime estimates, also published in the New England Journal of Medicine in 2025 (doi: 10.1056/NEJMoa2415879).
Further studies evaluate the effect of projecting risk factor reductions on CVD and all-cause mortality at the population level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The GCVRC uses harmonized individual-level data from currently more than 2 Mio individuals from 133 cohorts, 40 countries and 6 continents, categorized in 8 geographical regions - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Australia. The database provides information on cardiovascular risk factors, including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as data on major cardiovascular outcomes and death.
Key inclusion criteria (1 listed)
- Population-based individual-level data with available information on the classical cardiovascular risk factors including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as the outcomes of interest.
Key exclusion criteria (4 listed)
- Participants with age below 18 years
- No information on the outcome of interest
- No information on the exposure of interest (CVD risk factors)
- History of CVD at baseline
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
Cardiovascular disease (CVD)
Time frame: Median follow-up of 7-10 years
Event rates of CVD and CVD subtypes: First fatal or non-fatal myocardial infarction, unstable angina, coronary revascularization, ischemic or hemorrhagic stroke, and cardiovascular or unclassifiable death. The type of outcome measurement varies across cohorts. CVD cases and subtypes are assessed by questionnaire information, national hospital discharge registry data, causes of death registry data or central death registries depending on the study protocol of the respective cohort studies.
Death from any cause
Time frame: Median follow-up of 7-10 years
Number of deaths from any cause.
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 27 Feb 2026.
- Background: PubMed 40162648Global Cardiovascular Risk Consortium; Magnussen C, Alegre-Diaz J, Al-Nasser LA, Amouyel P, Aviles-Santa L, Bakker SJL, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Boffetta P, Brenner H, Brunstrom M, Can G, Carrillo-Larco RM, Checkley W, Dallongeville J, De Bacquer D, de Gaetano G, de Lemos JA, di Carluccio E, Dobson A, Donfrancesco C, Dorr M, d'Orsi E, Drygas W, Dullaart RPF, Engstrom G, Ferrario MM, Ferrieres J, Figtree GA, Gaye B, Ghayour-Mobarhan M, Goldbourt U, Gonzalez C, Gossling A, Grassi G, Gupta PC, He J, Hodge AM, Hozawa A, Hveem K, Iacoviello L, Ikram MK, Inoue M, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Klotsche J, Koenig W, Kontsevaya A, Kowlessur S, Kuri-Morales P, Kuulasmaa K, Kweon SS, Lackner KJ, Landmesser U, Leistner DM, Leiva Sisnieguez CE, Leong D, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, McElduff P, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Munzinger J, Nalini M, Nambi V, Nilsson PM, Ninomiya T, Omland T, Ong SK, Oppermann K, Pajak A, Palmieri L, Panagiotakos D, Park SK, Pednekar MS, Perianayagam A, Peters A, Poustchi H, Prabhakaran D, Prentice AM, Prescott E, Quyyumi A, Riserus U, Sakata S, Salazar M, Salomaa V, Sans S, Sattler ELP, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw J, Simons LA, Soderberg S, Tamosiunas A, Tapia-Conyer R, Thorand B, Tunstall-Pedoe H, Tuomilehto J, Twerenbold R, Vanuzzo D, Veronesi G, Wannamethee SG, Watanabe M, Weimann J, Wild PS, Yao Y, Zeng Y, Ziegler A, Ojeda FM, Blankenberg S; The Global Cardiovascular Risk Consortium. Global Effect of Cardiovascular Risk Factors on Lifetime Estimates. N Engl J Med. 2025 Jul 10;393(2):125-138. doi: 10.1056/NEJMoa2415879. Epub 2025 Mar 30.
- Background: PubMed 37632466Global Cardiovascular Risk Consortium; Magnussen C, Ojeda FM, Leong DP, Alegre-Diaz J, Amouyel P, Aviles-Santa L, De Bacquer D, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Brenner H, Carrillo-Larco RM, de Lemos J, Dobson A, Dorr M, Donfrancesco C, Drygas W, Dullaart RP, Engstrom G, Ferrario MM, Ferrieres J, de Gaetano G, Goldbourt U, Gonzalez C, Grassi G, Hodge AM, Hveem K, Iacoviello L, Ikram MK, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Koenig W, Kontsevaya A, Kuulasmaa K, Lackner KJ, Leistner DM, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Nalini M, Nambi V, Ninomiya T, Oppermann K, d'Orsi E, Pajak A, Palmieri L, Panagiotakos D, Perianayagam A, Peters A, Poustchi H, Prentice AM, Prescott E, Riserus U, Salomaa V, Sans S, Sakata S, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw JE, Simons LA, Soderberg S, Tamosiunas A, Thorand B, Tunstall-Pedoe H, Twerenbold R, Vanuzzo D, Veronesi G, Waibel J, Wannamethee SG, Watanabe M, Wild PS, Yao Y, Zeng Y, Ziegler A, Blankenberg S. Global Effect of Modifiable Risk Factors on Cardiovascular Disease and Mortality. N Engl J Med. 2023 Oct 5;389(14):1273-1285. doi: 10.1056/NEJMoa2206916. Epub 2023 Aug 26.
- Individual participant dataSharing planned: No
Related trials for All-cause Mortality
Not yet recruitingObservational study
Stress Hyperglycemia Ratio and Glucose Variability in Critically Ill Patients
Critical Illness, Hyperglycemia
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
Active, not recruitingPhase 3
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
Kidney Disease, Chronic, Renal Transplant Failure
Not yet recruitingObservational study
Evaluation of Three Trauma Mortality Scores in Adults Admitted to Intensive Care in Tunisia
Wounds and Injuries, Mortality
Not yet recruiting
A Cluster-Randomized Controlled Trial
Hypertension, Stroke
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.
Prof. Dr. med. Stefan Blankenberg study chair
Universitätsklinikum Hamburg-Eppendorf
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 All-cause Mortality and Cardiovascular Disease, 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 1 inclusion and 4 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 27 Feb 2026. 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 Prof. Dr. med. Stefan Blankenberg (+49 (0)40 741056800, s.blankenberg@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease (CVD) (time frame: Median follow-up of 7-10 years). The study lists 2 primary outcomes in all. 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 NCT05466825, which also lists 2 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 Feb 2026.