Acute Heart Failure (AHF)NCT06993220
Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients
An observational study of Acute Heart Failure (AHF) and Congestive Heart Failure(CHF), run by Consorci Sanitari Integral at 1 site in Spain.
Trial summary
Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Congestive Heart Failure(CHF)
- What is being tested?
- Evaluation of residual congestion at discharge
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 1 Jan 2027
- 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: Patients hospitalized for acute heart failure
Who may be able to join
- Age ≥ 18 years.
- Patients hospitalized for new onset heart failure or worsening heart failure defined by:
- Symptoms classified as New York Heart Association class III or IV.
- Clinical or instrumental signs of volume overload (e.g., dyspnea with evidence of pulmonary congestion on X-rays or lung ultrasound, pitting edema, and jugular venous distension).
- Elevated NT-proBNP levels within the first 24 hours of admission (cutoff values: 450 ng/L for patients < 50 years; >900 ng/L for patients aged 50-75 years; >1800 ng/L for patients >75 years).
- Ability to provide informed consent.
Who cannot join
- Known diagnosis of septicemia.
- Glomerular filtration rate < 15 ml/min.
- Life expectancy < 6 months.
- Active myocarditis.
- Heart transplant recipients.
- Patients with ventricular assist devices.
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- Congenital heart diseases.
- Moderate-to-severe liver disease (Child-Pugh B-C).
- Patients that will not be followed up by the Heart Failure Unit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complex Hospitalari Universitari Moisès Broggi
Sant Joan Despí, Barcelona, 08970
Giosafat Spitaleri, M.D., +34654471303, gspitaleri@csi.cat
Giosafat Spitaleri, M.D.
About this study
Official title: Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure
Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. While this association has been demonstrated, previous studies have primarily focused on single parameters of congestion (physical examination, biomarkers, or imaging features). The aim of the study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, the analysis will be supported by artificial intelligence to develop a multiparametric prognostic algorithm that can provide an improved predictive model compared to standard statistical approaches.
- Being tested
- Evaluation of residual congestion at discharge
- Keywords
- acute heart failure, residual congestion, multiparametric assessment, risk stratification
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of residual congestion at dischargeDiagnostic test
Evaluation of residual congestion at discharge will be made using:
- Clinical variables: composite congestion score calculated by summing the individual scores for orthopnoea, jugular venous distension and pedal oedema;
- Imaging variables: non-invasive left ventricular filling pressure, number of LUS B lines and the presence of pleural effusion, Venous Excess UltraSound (VExUS) score;
- Laboratory variables: hemoglobin and hematocrit, NT-proBNP, CA-125, ST2, troponin T, creatinine, AST, ALT, Na, K, urea, bilirubin, C-reactive protein.
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for acute heart failure | Not described Receives: Diagnostic Test: Evaluation of residual congestion at discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening heart failure or cardiovascular death
Occurrence of the composite of cardiovascular death and worsening heart failure (defined as unplanned hospitalization or urgent visit resulting in diuretic intravenous therapy)
Measured: 6 months after hospital discharge
Secondary outcomes (3)
all-cause death
Measured: 6 months after hospital discharge
time to first heart failure event
Measured: 6 months after hospital discharge
number of heart failure events
Measured: 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giosafat Spitaleri, M.D., Principal investigator, Consorci Sanitari Integral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993220
- Sponsor's protocol ID
- 24/53
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT06993220
- Acronym / sponsor ID
- 24/53
- Keywords
- acute heart failure, residual congestion, multiparametric assessment, risk stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 28 May 2025 (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.
Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. While this association has been demonstrated, previous studies have primarily focused on single parameters of congestion (physical examination, biomarkers, or imaging features). The aim of the study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, the analysis will be supported by artificial intelligence to develop a multiparametric prognostic algorithm that can provide an improved predictive model compared to standard statistical approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for acute heart failure | – | Diagnostic Test: Evaluation of residual congestion at discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for acute heart failure
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Patients hospitalized for new onset heart failure or worsening heart failure defined by:
- Ability to provide informed consent.
Key exclusion criteria (9 listed)
- Known diagnosis of septicemia.
- Glomerular filtration rate < 15 ml/min.
- Life expectancy < 6 months.
- Active myocarditis.
- Heart transplant recipients.
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 |
|---|---|---|
| Evaluation of residual congestion at dischargeEvaluation of residual congestion at discharge will be made using: * Clinical variables: composite congestion score calculated by summing the individual scores for orthopnoea, jugular venous distension and pedal oedema; * Imaging variables: non-invasive left ventricular filling pressure, number of LUS B lines and the presence of pleural effusion, Venous Excess UltraSound (VExUS) score; * Laboratory variables: hemoglobin and hematocrit, NT-proBNP, CA-125, ST2, troponin T, creatinine, AST, ALT, Na, K, urea, bilirubin, C-reactive protein. | Diagnostic test | Patients hospitalized for acute heart failure |
Primary outcome
Worsening heart failure or cardiovascular death
Time frame: 6 months after hospital discharge
Occurrence of the composite of cardiovascular death and worsening heart failure (defined as unplanned hospitalization or urgent visit resulting in diuretic intravenous therapy)
3 secondary outcomes
all-cause death
Time frame: 6 months after hospital discharge
time to first heart failure event
Time frame: 6 months after hospital discharge
number of heart failure events
Time frame: 6 months after hospital discharge
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 18 Jul 2025.
- 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.
Giosafat Spitaleri, M.D. principal investigator
Consorci Sanitari Integral
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 Acute Heart Failure (AHF) and Congestive Heart Failure(CHF), run by Consorci Sanitari Integral 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 6 inclusion and 9 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 18 Jul 2025. 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?
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 Giosafat Spitaleri, M.D. (+34 654471303, gspitaleri@csi.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening heart failure or cardiovascular death (time frame: 6 months after hospital discharge). 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 18 Jul 2025.