Heart FailureBEAT-HFNCT06255418
Big Data to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure
An observational study of Heart Failure and Acute Coronary Syndrome, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The goal of this observational study is to define the incidence of heart failure (HF) after acute coronary syndrome (ACS). The main question it aims to answer is: To define HF incidence in the medium and long-term in the context of public healthcare coverage ensuring universal access to early coronary… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Acute Coronary Syndrome, Heart Decompensation
- How many people
- 7,860,560 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2012to 31 Dec 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Analyses will cover the entire population of Catalonia (Spain, N = 7.860.563 as of December 31st, 2020), a region in which the Catalan Health Service granted universal health coverage.
Who may be able to join
- Admission with the primary diagnosis of acute coronary syndrome ( Non-ST-Elevation Myocardial Infarction -NSTEMI-, ST-Elevation Myocardial Infarction -STEMI-, Unestable Angina -UA-)
Who cannot join
- Diagnosis of heart failure (HF) in the year preceding the inclusion.
- Death before discharge from index event.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Big Data and Real-world Evidence to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure: the BEAT-HF Study
The goal of this observational study is to define the incidence of heart failure (HF) after acute coronary syndrome (ACS). The main question it aims to answer is:
- To define HF incidence in the medium and long-term in the context of public healthcare coverage ensuring universal access to early coronary revascularization after ACS and extended neurohormonal treatment.
Analyses will cover the entire population of Catalonia (North-Eastern region of Spain, N = 7.860.563 in 2020).
Researchers will compare HF incidence rate according to relevant subgroup characteristics including event type, age groups or sex, inter alia.
Read the detailed description
The aim of this project is to gain a better understanding, from a population perspective, of incident heart failure (HF) after acute coronary syndrome (ACS). The particular purpose is to define its incidence in the medium and long-term in the context of public healthcare coverage ensuring universal access to early coronary revascularization after ACS and extended neurohormonal treatment. To provide answer to this objective, a retrospective study were designed where a variety of study designs and analytic approaches will be used, aimed at maximizing the robustness of the results and at minimizing their sensitivity to specific study design assumptions. Analyses will cover the entire population of Catalonia (Spain, N = 7.860.563 as of December 31st, 2020), a region in which the Catalan Health Service granted universal health coverage. The study period will be defined between January 1st, 2012, and December 31st, 2021 covering 10 years. Inclusion criteria will be to have been admitted and diagnosed with a primary diagnosis of ACS (non-ST-segment elevation myocardial infarction -NSTEMI-, ST-segment elevation myocardial infarction -STEMI-, unstable angina -UA-) during the index event and to have been discharged alive during this period. The first co-primary outcome is to define the baseline characteristics of the ACS population, overall and according to clinical interest groups including event type (STEMI, NSTEMI, UA) and other relevant subgroups of patients. The second co-primary outcome of the study is the incidence rate of HF after ACS of all patients discharged alive after an ACS in Catalonia during this period. Incidence rate will also be described overall and according to relevant subgroup characteristics including event type, clinical phenotypes surrogate of impairment in regional or global systolic function, age groups, sex, diabetes mellitus, HF complicating index ACS, recurrent ACS after index ACS, socioeconomic status, treatments, comorbidity groups and procedures. Other clinical outcomes will be assessed as secondary outcomes (all-cause death, stroke, recurrent ACS, hospitalizations, major adverse cardiac event, etc.).
- Conditions
- Heart Failure, Acute Coronary Syndrome, Heart Decompensation, Myocardial Infarction, Acute
- Keywords
- heart failure, acute coronary syndrome, real-world evidence, healthcare resources consumption, long-term heart failure, big data
- Medical subject headings
- Heart Failure, Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics
The first co-primary outcome is to define the baseline characteristics of the ACS population, overall and according to clinical interest groups including event type (STEMI, NSTEMI, UA) and other relevant subgroups of patients.
Measured: Between January 1st, 2012 and 31st, December 2021 (study period).
Incidence of heart failure after acute coronary syndrome
The second co-primary outcome of the study is the incidence rate of HF after ACS of all patients discharged alive after an ACS in Catalonia
Measured: Between January 1st, 2012 and 31st, December 2021 (study period).
Secondary outcomes (2)
Clinical endpoints
- All-cause death
- Left ventricular assist device (LVAD) implant
- Heart transplant (HTx)
- Need of cardiovascular (CV) procedures: coronary artery bypass grafting (CABG), percutaneous revascularization, implantable cardioverter-defibrillator (ICD) implant
- Recurrent acute coronary syndromes (ACS)
- Stroke
- Cardiovascular (CV)-related hospitalization
- Heart Failure (HF) hospitalization
- 5-point MACE: death, incident HF, new ACS, stroke, need of cardiovascular intervention (CABG or percutaneous revascularization)
- Relevant cardiovascular medication by therapeutic class during the first year after the event.
Measured: Between January 1st, 2012 and 31st, December 2021 (study period).
Healthcare resource use endpoints
- Emergency Department (ED) visits
- Daycare visits
- Outpatient specialist contacts
- Total primary care contacts
- Primary care nurse contacts
- Primary care physician contacts
- Use of skilled nurse facility
- Unplanned HF admission
- Unplanned CV readmission
- Unplanned clinically related readmission (includes CV readmissions, admissions related to pre-existing chronic non-CV conditions and complications attributable to the index hospitalization)
- Unplanned all-cause hospitalization
- Length of hospitalization (days per admission)
- Healthcare expenditure: global and stratified according to specific concepts and activities
- Drug costs
Measured: Between January 1st, 2012 and 31st, December 2021 (study period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jan 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 7,860,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Principal investigator, Josep Comín, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255418
- Sponsor's protocol ID
- PR251/22
- Acronym
- BEAT-HF
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Comin Colet J, Basalo M, Llagostera M, Vela E, Folguera J, Llao I, Gomez-Lara J, Monterde D, Piera-Jimenez J, Carot-Sans G, Ramos-Polo R, Verdu-Rotellar JM, Jose-Bazan N, Lorenzo-Esteller L, Jovells S, Cosa A, Moliner P, Villarreal MA, Enjuanes-Grau C, Merono O. Ten-year incidence and prognostic impact of new-onset heart failure after acute coronary syndromes: a population-based study (BEAT-HF). Rev Esp Cardiol (Engl Ed). 2026 Aug;79(8):701-712. doi: 10.1016/j.rec.2026.02.003. Epub 2026 Feb 25. English, Spanish.
PubMed 41759889
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big Data and Real-world Evidence to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure: the BEAT-HF Study
- ClinicalTrials.gov ID
- NCT06255418
- Acronym / sponsor ID
- BEAT-HF / PR251/22
- Conditions
- Heart Failure, Acute Coronary Syndrome, Heart Decompensation, Myocardial Infarction, Acute
- Keywords
- heart failure, acute coronary syndrome, real-world evidence, healthcare resources consumption, long-term heart failure, big data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,860,560 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Feb 2024 (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 define the incidence of heart failure (HF) after acute coronary syndrome (ACS). The main question it aims to answer is:
- To define HF incidence in the medium and long-term in the context of public healthcare coverage ensuring universal access to early coronary revascularization after ACS and extended neurohormonal treatment.
Analyses will cover the entire population of Catalonia (North-Eastern region of Spain, N = 7.860.563 in 2020).
Researchers will compare HF incidence rate according to relevant subgroup characteristics including event type, age groups or sex, inter alia.
Detailed description
The aim of this project is to gain a better understanding, from a population perspective, of incident heart failure (HF) after acute coronary syndrome (ACS). The particular purpose is to define its incidence in the medium and long-term in the context of public healthcare coverage ensuring universal access to early coronary revascularization after ACS and extended neurohormonal treatment. To provide answer to this objective, a retrospective study were designed where a variety of study designs and analytic approaches will be used, aimed at maximizing the robustness of the results and at minimizing their sensitivity to specific study design assumptions. Analyses will cover the entire population of Catalonia (Spain, N = 7.860.563 as of December 31st, 2020), a region in which the Catalan Health Service granted universal health coverage. The study period will be defined between January 1st, 2012, and December 31st, 2021 covering 10 years. Inclusion criteria will be to have been admitted and diagnosed with a primary diagnosis of ACS (non-ST-segment elevation myocardial infarction -NSTEMI-, ST-segment elevation myocardial infarction -STEMI-, unstable angina -UA-) during the index event and to have been discharged alive during this period. The first co-primary outcome is to define the baseline characteristics of the ACS population, overall and according to clinical interest groups including event type (STEMI, NSTEMI, UA) and other relevant subgroups of patients. The second co-primary outcome of the study is the incidence rate of HF after ACS of all patients discharged alive after an ACS in Catalonia during this period. Incidence rate will also be described overall and according to relevant subgroup characteristics including event type, clinical phenotypes surrogate of impairment in regional or global systolic function, age groups, sex, diabetes mellitus, HF complicating index ACS, recurrent ACS after index ACS, socioeconomic status, treatments, comorbidity groups and procedures. Other clinical outcomes will be assessed as secondary outcomes (all-cause death, stroke, recurrent ACS, hospitalizations, major adverse cardiac event, etc.).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Analyses will cover the entire population of Catalonia (Spain, N = 7.860.563 as of December 31st, 2020), a region in which the Catalan Health Service granted universal health coverage.
Key inclusion criteria (1 listed)
- Admission with the primary diagnosis of acute coronary syndrome ( Non-ST-Elevation Myocardial Infarction -NSTEMI-, ST-Elevation Myocardial Infarction -STEMI-, Unestable Angina -UA-)
Key exclusion criteria (2 listed)
- Diagnosis of heart failure (HF) in the year preceding the inclusion.
- Death before discharge from index event.
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
Baseline characteristics
Time frame: Between January 1st, 2012 and 31st, December 2021 (study period).
The first co-primary outcome is to define the baseline characteristics of the ACS population, overall and according to clinical interest groups including event type (STEMI, NSTEMI, UA) and other relevant subgroups of patients.
Incidence of heart failure after acute coronary syndrome
Time frame: Between January 1st, 2012 and 31st, December 2021 (study period).
The second co-primary outcome of the study is the incidence rate of HF after ACS of all patients discharged alive after an ACS in Catalonia
2 secondary outcomes
Clinical endpoints
Time frame: Between January 1st, 2012 and 31st, December 2021 (study period).
Healthcare resource use endpoints
Time frame: Between January 1st, 2012 and 31st, December 2021 (study period).
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 16 Feb 2024.
- Derived from this study: PubMed 41759889Comin Colet J, Basalo M, Llagostera M, Vela E, Folguera J, Llao I, Gomez-Lara J, Monterde D, Piera-Jimenez J, Carot-Sans G, Ramos-Polo R, Verdu-Rotellar JM, Jose-Bazan N, Lorenzo-Esteller L, Jovells S, Cosa A, Moliner P, Villarreal MA, Enjuanes-Grau C, Merono O. Ten-year incidence and prognostic impact of new-onset heart failure after acute coronary syndromes: a population-based study (BEAT-HF). Rev Esp Cardiol (Engl Ed). 2026 Aug;79(8):701-712. doi: 10.1016/j.rec.2026.02.003. Epub 2026 Feb 25. English, Spanish.
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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 Acute Coronary Syndrome, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 16 Feb 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 Spain. 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?
Baseline characteristics (time frame: Between January 1st, 2012 and 31st, December 2021 (study period).). 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 NCT06255418, which also lists 1 linked publication.
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 16 Feb 2024.