Heart FailureACHILLESNCT07817576
Serial Biomarker Testing and Cardiovascular Risk Stratification (ACHILLES)
An observational study of Heart Failure and ASCVD, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
The goal of this observational study is to learn how blood levels of biomarkers, e.g. hsCRP and Lp(a) - two markers linked to heart disease risk - change over time in patients who have had these levels tested more than once. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, ASCVD, CKD
- How many people
- 110,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2004to 1 Jan 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Agnostic design. All-comers cohort at the University Hospital Freiburg, Department of Cardiology. Locations Freiburg and Bad-Krozingen
Who may be able to join
- Available Biomarker Measurement
Who cannot join
- < 18 years, Biomarker not available
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology - Freiburg - Bad Krozingen
Freiburg im Breisgau
About this study
Official title: Assessing Cardiovascular Hazard Via Intraindividual Biomarker Longitudinal Lability: an Evaluation of Serial Testing
The goal of this observational study is to learn how blood levels of biomarkers, e.g. hsCRP and Lp(a) - two markers linked to heart disease risk - change over time in patients who have had these levels tested more than once. The main questions it aims to answer are:
How often does a high result on a first test return to normal on a later test? Do patients whose levels stay high across repeated tests have a higher risk of death than patients whose high level was only temporary
Read the detailed description
Single measurements of cardiovascular risk biomarkers such as high-sensitivity C-reactive protein (hsCRP) and lipoprotein(a) [Lp(a)] are often used to classify patients as low- or high-risk, but biological and measurement variability means a single elevated value may not reflect a patient's true, sustained risk status. This study examines intraindividual variability in serial hsCRP and Lp(a) measurements among patients with repeated testing, to determine how often an initially elevated value normalizes on subsequent testing, and whether persistently elevated levels - rather than a single elevated measurement - better identify patients at genuinely increased cardiovascular risk.
Using retrospective, repeated-measures data, patients are classified by testing strategy: a single-measurement approach (elevated vs. not, based on the first available value) versus a serial-measurement approach (persistently elevated across multiple tests vs. transiently elevated vs. never elevated). Cardiovascular outcomes and all-cause mortality are compared across these classification strategies to assess whether transient biomarker elevation carries the same prognostic weight as persistent elevation, and whether repeated testing meaningfully improves risk stratification over a single measurement.
The findings are intended to inform whether current single-test-based risk classification should be reconsidered in favor of confirmatory or serial biomarker testing, for both hsCRP and Lp(a), in cardiovascular risk assessment.
- Conditions
- Heart Failure, ASCVD, CKD
- Keywords
- Retrospective, Cardiovascular Disease, Prognosis, hsCRP, Lipoprotein (a), Biomarker, Outcome, Variability
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Cohort | Total Cohort | |
| ≥2 Test Cohort | Not described | |
| ≥3 Test Cohort | Not described | |
| ≥4 Test Cohort | Not described | |
| ≥5 Test Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
From registration office (Meldeamt)
Measured: Mortality is assessed at a defined time point (23rd June, 2026) as provided by the registration office (deceased yes/no)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Jan 2004
- Primary completion1 Jul 2025
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Retrospective
- Enrolment
- 110,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Siegel, MD, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817576
- Sponsor's protocol ID
- 25-1269-S1-retro
- Acronym
- ACHILLES
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cardiovascular Hazard Via Intraindividual Biomarker Longitudinal Lability: an Evaluation of Serial Testing
- ClinicalTrials.gov ID
- NCT07817576
- Acronym / sponsor ID
- ACHILLES / 25-1269-S1-retro
- Conditions
- Heart Failure, ASCVD, CKD
- Keywords
- Retrospective, Cardiovascular Disease, Prognosis, hsCRP, Lipoprotein (a), Biomarker, Outcome, Variability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110,000 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 14 Sep 2026 (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 goal of this observational study is to learn how blood levels of biomarkers, e.g. hsCRP and Lp(a) - two markers linked to heart disease risk - change over time in patients who have had these levels tested more than once. The main questions it aims to answer are:
How often does a high result on a first test return to normal on a later test? Do patients whose levels stay high across repeated tests have a higher risk of death than patients whose high level was only temporary
Detailed description
Single measurements of cardiovascular risk biomarkers such as high-sensitivity C-reactive protein (hsCRP) and lipoprotein(a) [Lp(a)] are often used to classify patients as low- or high-risk, but biological and measurement variability means a single elevated value may not reflect a patient's true, sustained risk status. This study examines intraindividual variability in serial hsCRP and Lp(a) measurements among patients with repeated testing, to determine how often an initially elevated value normalizes on subsequent testing, and whether persistently elevated levels - rather than a single elevated measurement - better identify patients at genuinely increased cardiovascular risk.
Using retrospective, repeated-measures data, patients are classified by testing strategy: a single-measurement approach (elevated vs. not, based on the first available value) versus a serial-measurement approach (persistently elevated across multiple tests vs. transiently elevated vs. never elevated). Cardiovascular outcomes and all-cause mortality are compared across these classification strategies to assess whether transient biomarker elevation carries the same prognostic weight as persistent elevation, and whether repeated testing meaningfully improves risk stratification over a single measurement.
The findings are intended to inform whether current single-test-based risk classification should be reconsidered in favor of confirmatory or serial biomarker testing, for both hsCRP and Lp(a), in cardiovascular risk assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Total Cohort | – | –Total Cohort |
| ≥2 Test Cohort | – | – |
| ≥3 Test Cohort | – | – |
| ≥4 Test Cohort | – | – |
| ≥5 Test Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Agnostic design. All-comers cohort at the University Hospital Freiburg, Department of Cardiology. Locations Freiburg and Bad-Krozingen
Key inclusion criteria (1 listed)
- Available Biomarker Measurement
Key exclusion criteria (1 listed)
- < 18 years, Biomarker not available
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
Mortality
Time frame: Mortality is assessed at a defined time point (23rd June, 2026) as provided by the registration office (deceased yes/no)
From registration office (Meldeamt)
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 14 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure and ASCVD, run by University Hospital Freiburg 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 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 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?
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?
Mortality (time frame: Mortality is assessed at a defined time point (23rd June, 2026) as provided by the registration office (deceased yes/no)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.