Heart Failure With Reduced Ejection Fraction (HFrEF)NCT07470554
BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure
An observational study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Congestive Heart Failure(CHF), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This retrospective study will take advantage of an existing EU-funded dataset, the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF), which was designed to identify biomarkers related to the response to guideline directed medical therapy, and coordinated by UMCG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF), Congestive Heart Failure(CHF)
- How many people
- 4,254 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2024to 10 Jan 2034
- 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: The study population will be patients with congestive HF previously enrolled in the BIOSTAT-CHF cohorts. The index cohort consists of a prospectively enrolled series of 2516 patients from 69 centres in 11 European countries recruited between December 2010 and December 2012 and with a median follow-up of 21 months [interquartile range (IQR) 15 - 27 months]. Validation cohort was designed as well as a multicentre, prospective, observational study, which included 1738 patients from six centres in Scotland, United Kingdom
Who may be able to join
- In order to have been included to participate in the index trial, a subject must have met all of the following criteria:
- age >=18 years with symptoms of new-onset or worsening heart failure;
- objective evidence of cardiac dysfunction documented either by left ventricular ejection fraction <=40% or plasma concentrations of brain natriuretic peptide (BNP) >400 pg/mL and/or NT-proBNP >2000 pg/mL;
- treatment with either oral or intravenous furosemide >=40 mg/day or equivalent at the time of inclusion; not previously treated with evidence-based therapies (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers) or receiving <=50% of target doses of these drugs at the time of inclusion; anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers by the treating physician.
- For the validation cohort, patients had to fulfil the following inclusion criteria:
- age >=18 years;
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- diagnosis of heart failure with a previous documented admission requiring diuretic treatment;
- treatment with furosemide >=20 mg/day or equivalent;
- not previously treated or receiving <=50% of target doses of ACE inhibitors or ARBs and/or beta-blockers;
- anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers. In both trials, patients could be enrolled as inpatients or from outpatient clinics.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- known diagnosis of septicaemia, known diagnosis of acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy, heart transplant recipient or admitted for cardiac transplantation or left ventricular assist device surgery, anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and-or cardiac resynchronization therapy, within 4 weeks, current known inability to follow instructions or comply with follow-up procedures, and treatment with medications or devices not approved in Europe.
- Patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, could be included when the primary diagnosis for admission to hospital or outpatient clinic visit was heart failure, rather than the concomitant condition
Trial locations and contacts
1 site in 1 country.
Italy1 site
Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Emilia-Romagna, 40138
About this study
Official title: BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure Discovery - a BIOSTAT-CHF Substudy BIOTOOL-CHF DISCO
This retrospective study will take advantage of an existing EU-funded dataset, the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF), which was designed to identify biomarkers related to the response to guideline directed medical therapy, and coordinated by UMCG.
The availability of this comprehensive dataset of patients with severe HFrEF, prospectively and consistently collected, with the possibility to access a biobank to re-assay samples with novel biomarkers, provides a unique opportunity to derive preliminary data about the interaction between biomarkers of congestion and diuretic doses, that were prescribed based on clinical judgement, and therefore derive a machine learning-based algorithm than could be tested to guide the management of diuretic therapy
Read the detailed description
This is a retrospective study based on the index and the validation cohorts of the BIOSTAT-CHF project. The index cohort consists of a prospectively enrolled series of 2516 patients from 69 centres in 11 European countries recruited between December 2010 and December 2012 and with a median follow-up of 21 months [interquartile range (IQR) 15 - 27 months]. Validation cohort was designed as well as a multicentre, prospective, observational study, which included 1738 patients from six centres in Scotland, United Kingdom.
BIOSTAT-CHF samples and data will be re-analysed to include additional congestion biomarkers, to obtain the BIOTOOL-CHF DISCO dataset. The latter has been used to derive a predictive model for congestion-related adverse events, priming the design of a prospective randomized study (the BIOTOOL-CHF VALID study).
Preliminary analysis reported advanced age, higher blood urea nitrogen and N-terminal pro-B-type natriuretic peptide (NT-proBNP), lower haemoglobin, and failure to prescribe a beta-blocker as the five strongest predictors of mortality. Moreover, the five strongest predictors of hospitalisation due to decompensated HF were more advanced age, previous hospitalisation owing to HF, presence of oedema, lower systolic blood pressure and lower estimated glomerular filtration rate.
Capitalizing from these preliminary results, the BIOTOOL-CHF VALID study will test the score derived from the analysis of the BIOTOOL-CHF DISCO dataset, in order to guide therapy management in HF patients.
- Keywords
- Biomarkers, Score, Congestion
- Medical subject headings
- Heart Failure
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 |
|---|---|---|
| Index cohort | Not described | |
| Validation cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be time to death or first-hospitalisation for HF in the nine months after study entry
Measured: 9 month
Secondary outcomes (1)
- Variability in the congestion score assessed from baseline to Month 9 - Variability in the Kansas City Cardiomyopathy Questionnaire from baseline to month 9
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start10 Dec 2024
- Primary completion20 Feb 2025
- Study completion10 Jan 2034 (estimated)
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 Failure With Reduced Ejection Fraction (HFrEF)Studies 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
- 4,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470554
- Sponsor's protocol ID
- BIOTOOL-CHF DISCO
- Other IDs
- 101095653
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voors AA, Anker SD, Cleland JG, Dickstein K, Filippatos G, van der Harst P, Hillege HL, Lang CC, Ter Maaten JM, Ng L, Ponikowski P, Samani NJ, van Veldhuisen DJ, Zannad F, Zwinderman AH, Metra M. A systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure: rationale, design, and baseline characteristics of BIOSTAT-CHF. Eur J Heart Fail. 2016 Jun;18(6):716-26. doi: 10.1002/ejhf.531. Epub 2016 Apr 29.
PubMed 27126231
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure Discovery - a BIOSTAT-CHF Substudy BIOTOOL-CHF DISCO
- ClinicalTrials.gov ID
- NCT07470554
- Acronym / sponsor ID
- BIOTOOL-CHF DISCO
- Keywords
- Biomarkers, Score, Congestion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,254 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 10 Jan 2034 (estimated)
- First posted
- 13 Mar 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.
This retrospective study will take advantage of an existing EU-funded dataset, the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF), which was designed to identify biomarkers related to the response to guideline directed medical therapy, and coordinated by UMCG.
The availability of this comprehensive dataset of patients with severe HFrEF, prospectively and consistently collected, with the possibility to access a biobank to re-assay samples with novel biomarkers, provides a unique opportunity to derive preliminary data about the interaction between biomarkers of congestion and diuretic doses, that were prescribed based on clinical judgement, and therefore derive a machine learning-based algorithm than could be tested to guide the management of diuretic therapy
Detailed description
This is a retrospective study based on the index and the validation cohorts of the BIOSTAT-CHF project. The index cohort consists of a prospectively enrolled series of 2516 patients from 69 centres in 11 European countries recruited between December 2010 and December 2012 and with a median follow-up of 21 months [interquartile range (IQR) 15 - 27 months]. Validation cohort was designed as well as a multicentre, prospective, observational study, which included 1738 patients from six centres in Scotland, United Kingdom.
BIOSTAT-CHF samples and data will be re-analysed to include additional congestion biomarkers, to obtain the BIOTOOL-CHF DISCO dataset. The latter has been used to derive a predictive model for congestion-related adverse events, priming the design of a prospective randomized study (the BIOTOOL-CHF VALID study).
Preliminary analysis reported advanced age, higher blood urea nitrogen and N-terminal pro-B-type natriuretic peptide (NT-proBNP), lower haemoglobin, and failure to prescribe a beta-blocker as the five strongest predictors of mortality. Moreover, the five strongest predictors of hospitalisation due to decompensated HF were more advanced age, previous hospitalisation owing to HF, presence of oedema, lower systolic blood pressure and lower estimated glomerular filtration rate.
Capitalizing from these preliminary results, the BIOTOOL-CHF VALID study will test the score derived from the analysis of the BIOTOOL-CHF DISCO dataset, in order to guide therapy management in HF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index cohort | – | – |
| Validation cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients with congestive HF previously enrolled in the BIOSTAT-CHF cohorts. The index cohort consists of a prospectively enrolled series of 2516 patients from 69 centres in 11 European countries recruited between December 2010 and December 2012 and with a median follow-up of 21 months [interquartile range (IQR) 15 - 27 months]. Validation cohort was designed as well as a multicentre, prospective, observational study, which included 1738 patients from six centres in Scotland, United Kingdom
Key inclusion criteria (10 listed)
- In order to have been included to participate in the index trial, a subject must have met all of the following criteria:
- age >=18 years with symptoms of new-onset or worsening heart failure;
- objective evidence of cardiac dysfunction documented either by left ventricular ejection fraction <=40% or plasma concentrations of brain natriuretic peptide (BNP) >400 pg/mL and/or NT-proBNP >2000 pg/mL;
- treatment with either oral or intravenous furosemide >=40 mg/day or equivalent at the time of inclusion; not previously treated with evidence-based therapies (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers) or receiving <=50% of target doses of these drugs at the time of inclusion; anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers by the treating physician.
- age >=18 years;
Key exclusion criteria (3 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- known diagnosis of septicaemia, known diagnosis of acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy, heart transplant recipient or admitted for cardiac transplantation or left ventricular assist device surgery, anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and-or cardiac resynchronization therapy, within 4 weeks, current known inability to follow instructions or comply with follow-up procedures, and treatment with medications or devices not approved in Europe.
- Patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, could be included when the primary diagnosis for admission to hospital or outpatient clinic visit was heart failure, rather than the concomitant condition
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
The primary endpoint of the study will be time to death or first-hospitalisation for HF in the nine months after study entry
Time frame: 9 month
1 secondary outcome
- Variability in the congestion score assessed from baseline to Month 9 - Variability in the Kansas City Cardiomyopathy Questionnaire from baseline to month 9
Time frame: 9 months
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 7 May 2026.
- Results publication: PubMed 27126231Voors AA, Anker SD, Cleland JG, Dickstein K, Filippatos G, van der Harst P, Hillege HL, Lang CC, Ter Maaten JM, Ng L, Ponikowski P, Samani NJ, van Veldhuisen DJ, Zannad F, Zwinderman AH, Metra M. A systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure: rationale, design, and baseline characteristics of BIOSTAT-CHF. Eur J Heart Fail. 2016 Jun;18(6):716-26. doi: 10.1002/ejhf.531. Epub 2016 Apr 29.
- 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 With Reduced Ejection Fraction (HFrEF) and Congestive Heart Failure(CHF), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 10 inclusion and 3 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 7 May 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 Italy. 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?
The primary endpoint of the study will be time to death or first-hospitalisation for HF in the nine months after study entry (time frame: 9 month). 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 NCT07470554, 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 7 May 2026.