Acute Heart Failure (AHF)READ-MA-PRONONCT06692439
Acute Heart Failure in Elderly Patients Admitted to the Emergency Department with Acute Dyspnea: a Multimarker Approach Prognostic Study
An observational study of Acute Heart Failure (AHF) and Dyspnoea, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Background and Rationale: Acute dyspnea is a frequent presenting symptom in emergency departments (ED), with acute heart failure (AHF) being the most common cause leading to hospitalization in elderly patients. AHF in this population presents unique challenges in diagnosis, management, and risk stratification. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Dyspnoea
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Sep 2025
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients aged ≥75 years admitted to the ED for acute dyspnea
Who may be able to join
None listed.
Who cannot join
- No written consent for data use in the READ-MA-PRONO study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Thibaut DESMETTRE, MD, PhD contact
About this study
Background and Rationale:
Acute dyspnea is a frequent presenting symptom in emergency departments (ED), with acute heart failure (AHF) being the most common cause leading to hospitalization in elderly patients. AHF in this population presents unique challenges in diagnosis, management, and risk stratification. Current tools for severity assessment and risk stratification (NT-proBNP and echocardiography) have shown limited evolution over the past 20 years and remain insufficient, particularly for elderly patients who predominantly present with heart failure with preserved ejection fraction (HFpEF). Recent European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines specifically call for research on biomarkers within a multi-marker strategy for AHF risk stratification.
Read more
Research Hypothesis:
The study hypothesizes that a combination of biomarkers (NT-proBNP, High-sensitivity Troponin I, ST2, Galectin-3, CD146 and suPAR) will provide prognostic value and effectively stratify risk for early outcomes (90-day mortality and hospital readmission) in patients aged ≥75 years presenting to the ED with acute dyspnea and diagnosed with AHF.
Primary Objective:
To evaluate the prognostic value of six biomarkers, both individually and in combination, for predicting 90-day all-cause mortality or ED readmission in elderly patients (≥75 years) presenting with acute dyspnea and diagnosed with AHF.
Study Design:
This is a prospective prognostic study including patients from 7 emergency departments from university and non-university hospitals in France.
Study Population:
(I) Patients aged ≥75 years presenting to the ED with acute dyspnea meeting at least two criteria:
- Respiratory rate ≥25/min
- PaO2 ≤70 mmHg
- SpO2 ≤92% on room air
- PaCO2 ≥45 mmHg and pH ≤7.35
- Oxygen requirement (ii) Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo
Primary Endpoint:
Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.
Analysis plan includes:
- ROC curves for optimal biomarker thresholds
- Kaplan-Meier survival analysis with log-rank tests
- Univariate and multivariate Cox regression analyses
- Bootstrap methods for confidence intervals
- Conditions
- Acute Heart Failure (AHF), Dyspnoea
- Keywords
- acute heart failure, dyspnea, prognosis, biomarkers
- Medical subject headings
- Dyspnea
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 |
|---|---|---|
| acute heart failure | The presence or absence of acute left heart failure (gold standard) was determined through diagnosis by two experts (a cardiologist and an emergency physician) based on: 1. Data collected in the ED and during hospitalization: Clinical examination and history, Current medications, Hemodynamic parameters, ECG, Chest X-ray, Emergency interventions, Clinical and paraclinical findings during hospitalization 2. Biological assays (excluding NT-proBNP) 3. Echocardiography performed by a cardiologist within 24 hours of admission, including: Left Ventricular Ejection Fraction, Segmental wall motion, Presence of valvular disease, Transmitral flow, Tissue Doppler E' velocity anticipated, n = 185/450 (41%) | |
| no acute heart failure | The presence or absence of acute left heart failure (gold standard) was determined through diagnosis by two experts (a cardiologist and an emergency physician) based on: 1. Data collected in the ED and during hospitalization: Clinical examination and history, Current medications, Hemodynamic parameters, ECG, Chest X-ray, Emergency interventions, Clinical and paraclinical findings during hospitalization 2. Biological assays (excluding NT-proBNP) 3. Echocardiography performed by a cardiologist within 24 hours of admission, including: Left Ventricular Ejection Fraction, Segmental wall motion, Presence of valvular disease, Transmitral flow, Tissue Doppler E' velocity anticipated, n = 265/450 (59%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionSep 2025 (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.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric MAUNY, MD, PhD, Study chair, CHU BesançonMarc PUYRAVEAU, MSc, Study chair, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692439
- Sponsor's protocol ID
- 2022/725
- Acronym
- READ-MA-PRONO
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Heart Failure in Elderly Patients Admitted to the Emergency Department with Acute Dyspnea: a Multimarker Approach Prognostic Study
- ClinicalTrials.gov ID
- NCT06692439
- Acronym / sponsor ID
- READ-MA-PRONO / 2022/725
- Conditions
- Acute Heart Failure (AHF), Dyspnoea
- Keywords
- acute heart failure, dyspnea, prognosis, biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 Nov 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.
Background and Rationale:
Acute dyspnea is a frequent presenting symptom in emergency departments (ED), with acute heart failure (AHF) being the most common cause leading to hospitalization in elderly patients. AHF in this population presents unique challenges in diagnosis, management, and risk stratification. Current tools for severity assessment and risk stratification (NT-proBNP and echocardiography) have shown limited evolution over the past 20 years and remain insufficient, particularly for elderly patients who predominantly present with heart failure with preserved ejection fraction (HFpEF). Recent European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines specifically call for research on biomarkers within a multi-marker strategy for AHF risk stratification.
Research Hypothesis:
The study hypothesizes that a combination of biomarkers (NT-proBNP, High-sensitivity Troponin I, ST2, Galectin-3, CD146 and suPAR) will provide prognostic value and effectively stratify risk for early outcomes (90-day mortality and hospital readmission) in patients aged ≥75 years presenting to the ED with acute dyspnea and diagnosed with AHF.
Primary Objective:
To evaluate the prognostic value of six biomarkers, both individually and in combination, for predicting 90-day all-cause mortality or ED readmission in elderly patients (≥75 years) presenting with acute dyspnea and diagnosed with AHF.
Study Design:
This is a prospective prognostic study including patients from 7 emergency departments from university and non-university hospitals in France.
Study Population:
(I) Patients aged ≥75 years presenting to the ED with acute dyspnea meeting at least two criteria:
- Respiratory rate ≥25/min
- PaO2 ≤70 mmHg
- SpO2 ≤92% on room air
- PaCO2 ≥45 mmHg and pH ≤7.35
- Oxygen requirement (ii) Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo
Primary Endpoint:
Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.
Analysis plan includes:
- ROC curves for optimal biomarker thresholds
- Kaplan-Meier survival analysis with log-rank tests
- Univariate and multivariate Cox regression analyses
- Bootstrap methods for confidence intervals
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute heart failure | – | –The presence or absence of acute left heart failure (gold standard) was determined through diagnosis by two experts (a cardiologist and an emergency physician) based on: 1. Data collected in the ED and during hospitalization: Clinical examination and history, Current medications, Hemodynamic parameters, ECG, Chest X-ray, Emergency interventions, Clinical and paraclinical findings during hospitalization 2. Biological assays (excluding NT-proBNP) 3. Echocardiography performed by a cardiologist within 24 hours of admission, including: Left Ventricular Ejection Fraction, Segmental wall motion, Presence of valvular disease, Transmitral flow, Tissue Doppler E' velocity anticipated, n = 185/450 (41%) |
| no acute heart failure | – | –The presence or absence of acute left heart failure (gold standard) was determined through diagnosis by two experts (a cardiologist and an emergency physician) based on: 1. Data collected in the ED and during hospitalization: Clinical examination and history, Current medications, Hemodynamic parameters, ECG, Chest X-ray, Emergency interventions, Clinical and paraclinical findings during hospitalization 2. Biological assays (excluding NT-proBNP) 3. Echocardiography performed by a cardiologist within 24 hours of admission, including: Left Ventricular Ejection Fraction, Segmental wall motion, Presence of valvular disease, Transmitral flow, Tissue Doppler E' velocity anticipated, n = 265/450 (59%) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients aged ≥75 years admitted to the ED for acute dyspnea
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- No written consent for data use in the READ-MA-PRONO study
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
Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.
Time frame: 90-day
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 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Thibaut DESMETTRE, MD, PhD contact
Frédéric MAUNY, MD, PhD study chair
CHU Besançon
Marc PUYRAVEAU, MSc study chair
CHU Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF) and Dyspnoea, run by Centre Hospitalier Universitaire de Besancon.
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 0 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: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Omide TAHERI, MD, PhD (03.81.66.70.28, omide.taheri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients. (time frame: 90-day). 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 Nov 2024.