Heart FailureORACLENCT05679713
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
An observational study of Heart Failure, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The aim of this study is to develop and validate an improved, comprehensive risk assessment algorithm integrating blood RNA-based biomarkers, clinical, and patient-centered data and to assess the incremental predictive value (discrimination and reclassification) compared to a traditional risk model (change in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Comprehensive risk assessment algorithm
- How many people
- 1,134 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2022to 1 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The external validation cohort will be a multicenter, observational, prospective, cross-sectional and longitudinal cohort recruited for the specific purpose of the ORACLE study. The investigators plan to recruit patients with a recent (<30 days) acute HF event and follow them for 180 days. The study will be conducted in 4 different hospitals (University Hospital Bellvitge, Viladecans General Hospital, Vic General Hospital and Igualada General Hospital) covering a total healthcare area of > 650.000 inhabitants.
Who may be able to join
- Age ≥ 18 years old.
- Patients with a recent (<30 days) acute decompensation of HF requiring intravenous diuretic therapy (either hospitalized or in ambulatory care) or intensification of oral diuretics (ambulatory care).
- HF diagnosis according to European Society of Cardiology (ESC) criteria.
- Written informed consent
- Patients receiving oral standard medication for chronic HF.
Who cannot join
- Age<18 years old.
- Death before hospital discharge.
- The patient is unable or unwilling to give the informed consent to participate.
- Unstable patients with signs of fluid overload or low cardiac output at the moment of enrollment.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Josep Comín Colet, MD, PhD, +34-933-35-70-11 ext. 2274, jcomin@bellvitgehospital.cat
Raúl Ramos Polo, MD, +34-933-35-70-11 ext. 2274, rramosp@bellvitgehospital.cat
About this study
The aim of this study is to develop and validate an improved, comprehensive risk assessment algorithm integrating blood RNA-based biomarkers, clinical, and patient-centered data and to assess the incremental predictive value (discrimination and reclassification) compared to a traditional risk model (change in the c-statistics for prediction of the primary endpoint).
Read the detailed description
The ORACLE study is a multicenter, observational, prospective, cross-sectional and longitudinal study integrated by 3 different cohorts for 1) RNA biomarker discovery (60 nested case-control sample), 2) model derivation (516 nested case-control sample) and 3) external validation (new prospective cohort of 558 consecutive patients recruited in 4 hospital centers) according to a TRIPOD Statement type 3 analysis. In total 1134 consecutive patients with a HF hospitalization or urgent HF visit < 30 days before inclusion and followed for 6 months will be studied.
This study include the discovery of novel RNA-based biomarkers using next-generation sequencing technology to define and validate a new biomarker set and clinical and patient-centered risk determinants definition. A new model will be constructed; training and internal validation in the derivation cohort using machine learning methods, and finally an external validation of the new next generation integrative risk assessment model will be performed.
- Conditions
- Heart Failure
- Being tested
- Comprehensive risk assessment algorithm
- Keywords
- Machine Learning, Multi-Omics Approaches, Outcomes Research, Patient-Centered Information
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive risk assessment algorithmDiagnostic test
Risk assessment algorithm including clinical and patient-centered information and a novel RNA-based biomarkers using next-generation sequencing technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict HF related hospitalizations or all-cause death
To compare in an external validation cohort of patients a recent acute HF event, the performance (discrimination, additive predictive value, and reclassification ability) of a comprehensive risk assessment algorithm with the performance of a traditional risk model to predict the occurrence of the primary composite clinical end-point of HF related hospitalizations (readmissions) or all-cause death at 180 days after hospital discharge or after an urgent HF visit (acute HF event requiring intravenous administration of diuretics without admission).
Measured: 6 months
Secondary outcomes (3)
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of HF-related hospitalizations (readmissions) or all-cause death at 30, and 90 days after hospital discharge.
The admission will be considered as HF-related if it suits with one of the following conditions:
- Cardiovascular cause hospitalization
- Complication directly related with prior HF admission
- Decompensation of prior disease or comorbidity
Measured: 6 months
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of HF-related hospitalizations (readmissions) at 30, 90, and 180 days after hospital discharge.
Measured: 6 months
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of all-cause death at 30, 90, and 180 days, after hospital discharge.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start5 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Comín, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679713
- Sponsor's protocol ID
- PI21/00264
- Acronym
- ORACLE
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
- ClinicalTrials.gov ID
- NCT05679713
- Acronym / sponsor ID
- ORACLE / PI21/00264
- Conditions
- Heart Failure
- Keywords
- Machine Learning, Multi-Omics Approaches, Outcomes Research, Patient-Centered Information
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,134 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Jan 2023 (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 aim of this study is to develop and validate an improved, comprehensive risk assessment algorithm integrating blood RNA-based biomarkers, clinical, and patient-centered data and to assess the incremental predictive value (discrimination and reclassification) compared to a traditional risk model (change in the c-statistics for prediction of the primary endpoint).
Detailed description
The ORACLE study is a multicenter, observational, prospective, cross-sectional and longitudinal study integrated by 3 different cohorts for 1) RNA biomarker discovery (60 nested case-control sample), 2) model derivation (516 nested case-control sample) and 3) external validation (new prospective cohort of 558 consecutive patients recruited in 4 hospital centers) according to a TRIPOD Statement type 3 analysis. In total 1134 consecutive patients with a HF hospitalization or urgent HF visit < 30 days before inclusion and followed for 6 months will be studied.
This study include the discovery of novel RNA-based biomarkers using next-generation sequencing technology to define and validate a new biomarker set and clinical and patient-centered risk determinants definition. A new model will be constructed; training and internal validation in the derivation cohort using machine learning methods, and finally an external validation of the new next generation integrative risk assessment model will be performed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The external validation cohort will be a multicenter, observational, prospective, cross-sectional and longitudinal cohort recruited for the specific purpose of the ORACLE study. The investigators plan to recruit patients with a recent (<30 days) acute HF event and follow them for 180 days. The study will be conducted in 4 different hospitals (University Hospital Bellvitge, Viladecans General Hospital, Vic General Hospital and Igualada General Hospital) covering a total healthcare area of > 650.000 inhabitants.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Patients with a recent (<30 days) acute decompensation of HF requiring intravenous diuretic therapy (either hospitalized or in ambulatory care) or intensification of oral diuretics (ambulatory care).
- HF diagnosis according to European Society of Cardiology (ESC) criteria.
- Written informed consent
- Patients receiving oral standard medication for chronic HF.
Key exclusion criteria (4 listed)
- Age<18 years old.
- Death before hospital discharge.
- The patient is unable or unwilling to give the informed consent to participate.
- Unstable patients with signs of fluid overload or low cardiac output at the moment of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive risk assessment algorithmRisk assessment algorithm including clinical and patient-centered information and a novel RNA-based biomarkers using next-generation sequencing technology. | Diagnostic test | – |
Primary outcome
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict HF related hospitalizations or all-cause death
Time frame: 6 months
To compare in an external validation cohort of patients a recent acute HF event, the performance (discrimination, additive predictive value, and reclassification ability) of a comprehensive risk assessment algorithm with the performance of a traditional risk model to predict the occurrence of the primary composite clinical end-point of HF related hospitalizations (readmissions) or all-cause death at 180 days after hospital discharge or after an urgent HF visit (acute HF event requiring intravenous administration of diuretics without admission).
3 secondary outcomes
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of HF-related hospitalizations (readmissions) or all-cause death at 30, and 90 days after hospital discharge.
Time frame: 6 months
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of HF-related hospitalizations (readmissions) at 30, 90, and 180 days after hospital discharge.
Time frame: 6 months
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of all-cause death at 30, 90, and 180 days, after hospital discharge.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- 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.
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, 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 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Comín Colet, MD, PhD (+34 932607078, jcomin@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict HF related hospitalizations or all-cause death (time frame: 6 months). 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 11 Jan 2023.