Heart FailureECHO-DECOMPNCT07439159
Echocardiography-Based Predictors of Outcomes in Hospitalized Patients With Decompensated Heart Failure (ECHO-DECOMP)
An observational study of Heart Failure, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Acute decompensated heart failure is a leading cause of hospitalization and is associated with high morbidity and mortality. Early risk stratification in this population is crucial for guiding treatment strategies and predicting short- and long-term clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2024to Aug 2027
- How long will I take part?
- 90 Days
- 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 consist of adult patients hospitalized for acute decompensated heart failure at Istanbul University-Cerrahpaşa Cardiology Institute Hospital. Participants will be selected from patients presenting to the emergency department or cardiology outpatient clinics who require inpatient management for heart failure decompensation.
Who may be able to join
- Adults aged ≥18 years.
- Hospitalization due to acute decompensated heart failure.
- Intravenous diuretic therapy deemed necessary by the treating cardiologist.
- Predominant left-sided heart failure.
- Provision of written informed consent prior to participation.
Who cannot join
- Severe anemia (hemoglobin <7 g/dL).
- Requirement for renal replacement therapy, including hemodialysis or peritoneal dialysis, or being listed for kidney transplantation.
- Severe primary mitral regurgitation.
- Severe aortic stenosis.
- Severe aortic regurgitation.
- Severe primary tricuspid regurgitation.
Show all 15Show fewer
- Primary right heart failure.
- Heart failure secondary to congenital heart disease.
- History of mitral valve replacement.
- History of aortic valve replacement.
- History of bioprosthetic valve replacement.
- History of transcatheter aortic valve implantation.
- Presence of active malignancy.
- Failure to provide written informed consent.
- Inability to perform transthoracic echocardiography prior to intravenous diuretic therapy for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpaşa Institute of Cardiology
Istanbul
AYBİKE G TAŞDELEN ACAR, MD, +905356955610, aybikegul.tasdelen@iuc.edu.tr
Ümit Acar, +905424421411, umit.acar1@iuc.edu.tr
About this study
Official title: Early Transthoracic Echocardiographic Predictors of Recurrent Hospitalization and Survival in Patients Hospitalized Due to Decompensated Heart Failure
Acute decompensated heart failure is a leading cause of hospitalization and is associated with high morbidity and mortality. Early risk stratification in this population is crucial for guiding treatment strategies and predicting short- and long-term clinical outcomes. Transthoracic echocardiography is routinely performed in patients hospitalized with acute decompensated heart failure and provides comprehensive information regarding cardiac structure and function. However, the prognostic value of detailed echocardiographic parameters obtained before the initiation of intravenous diuretic therapy has not been fully clarified.
The objective of this prospective study is to evaluate the prognostic significance of transthoracic echocardiographic findings obtained at hospital admission, prior to intravenous diuretic therapy, in patients hospitalized with acute decompensated heart failure. The study will assess key echocardiographic parameters reflecting left and right heart structure and function, including left ventricular ejection fraction, left ventricular dimensions and geometry, left atrial size and volume, indices of right ventricular systolic function (such as TAPSE, tissue Doppler-derived S' velocity, and fractional area change), pulmonary artery systolic pressure, right ventricular-pulmonary artery coupling assessed by the TAPSE/PASP ratio, and right ventricular outflow tract acceleration time.
Read more
Primary outcome measures include in-hospital mortality, post-discharge mortality, myocardial infarction, ischemic stroke, and heart failure-related rehospitalization. Secondary outcomes include the need for non-invasive or invasive mechanical ventilation during hospitalization, requirement for inotropic support, changes in B-type natriuretic peptide levels, development of acute kidney injury, and occurrence of new-onset cardiac arrhythmias.
By prospectively evaluating echocardiographic parameters and their associations with clinical outcomes, this study aims to clarify the prognostic role of early echocardiographic assessment in acute decompensated heart failure and to contribute to improved risk stratification and clinical decision-making in this high-risk population.
Read the detailed description
This study will be designed as a prospective, single-center, observational investigation conducted at Istanbul University-Cerrahpaşa Cardiology Institute between December 2024 and December 2025. Based on an a priori power analysis performed using G*Power software for linear regression modeling, assuming a two-sided alpha error of 0.05 and 80% statistical power, a minimum of 76 patients will be required for adequate statistical validity.
Study Population
Consecutive adult patients presenting to the emergency department or outpatient cardiology clinic and hospitalized for acute decompensated heart failure following independent cardiologist evaluation and indication for intravenous diuretic therapy will be enrolled. Patients will be evaluated by the study investigator after admission and prior to the first intravenous diuretic administration.
Demographic variables (age, sex), anthropometric measurements (height, weight), body mass index calculated using the Quetelet formula (kg/m²), and body surface area calculated using the Mosteller formula (m²) will be recorded. Vital signs including systolic and diastolic blood pressure (mmHg), peripheral oxygen saturation (%), and heart rate (beats per minute) will be documented.
Comorbidities including hypertension, diabetes mellitus, atrial fibrillation, ischemic heart disease, chronic obstructive pulmonary disease, chronic kidney disease, hypothyroidism, ischemic cerebrovascular disease, peripheral arterial disease, and smoking status will be recorded.
Functional capacity will be evaluated according to the New York Heart Association (NYHA) classification.
Electrocardiographic Evaluation
Standard 12-lead electrocardiography will be obtained in the supine resting position at 25 mm/s speed and 10 mm/mV calibration. Rhythm will be categorized as sinus rhythm or atrial fibrillation. QRS duration will be measured from the onset of the Q wave to the end of the S wave in the lead demonstrating the widest morphology and recorded both as a continuous variable (ms) and categorized using a 120 ms threshold.
Heart Failure Classification and Medical Therapy
Heart failure etiology will be classified as ischemic or non-ischemic in previously diagnosed patients. In newly diagnosed cases, presumed etiology will be recorded at baseline and updated when definitive diagnosis is established.
Patients will be categorized according to ESC and ACC/AHA guideline-recommended left ventricular ejection fraction classifications:
HFrEF (EF <40%)
HFmrEF (EF 40-49%)
HFpEF (EF ≥50%)
Baseline medical therapy will be recorded, including the number and type of guideline-directed medical therapy (GDMT) agents. High-dose diuretic therapy will be defined as ≥80 mg/day for furosemide or ≥20 mg/day for torasemide. Combination diuretic therapy (loop plus thiazide or thiazide-like diuretic) will be documented. Presence of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) will be recorded.
Precipitating Factors
Potential precipitating factors for decompensation including atrial fibrillation with rapid ventricular response (defined as AF with resting ventricular rate ≥110 bpm), infection (defined by elevated CRP, leukocytosis, procalcitonin elevation, and compatible clinical findings), and acute kidney injury (defined according to KDIGO criteria) will be documented.
Laboratory Assessment
Admission laboratory parameters obtained without intervention will be extracted from the hospital information system and will include BUN, creatinine, estimated glomerular filtration rate (eGFR), sodium, potassium, AST, ALT, hemoglobin, hematocrit, white blood cell count, platelet count, HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, CRP, and B-type natriuretic peptide (BNP).
Patients with severe anemia (hemoglobin <7 g/dL) or receiving chronic dialysis therapy will be excluded.
Transthoracic Echocardiography
Comprehensive transthoracic echocardiography will be performed prior to intravenous diuretic therapy using a Philips EPIQ 7C ultrasound system equipped with an S5-1 phased-array transducer.
Patients will be examined in the left lateral decubitus position with ECG synchronization. In sinus rhythm, three consecutive cardiac cycles will be averaged; in atrial fibrillation, five consecutive cycles will be averaged.
Parasternal long-axis (PLAX), parasternal short-axis (PSAX), apical four-chamber (A4C), apical five-chamber (A5C), and apical two-chamber (A2C) views will be obtained.
Left ventricular ejection fraction will be calculated primarily using the biplane Simpson method. Left ventricular mass will be calculated using the Devereux formula and indexed to body surface area. Relative wall thickness and left ventricular eccentricity index (D2/D1 ratio) will be calculated.
Right ventricular systolic function will be assessed using:
Tricuspid annular plane systolic excursion (TAPSE)
Tissue Doppler-derived tricuspid annular systolic velocity (S')
Right ventricular fractional area change (FAC)
Right atrial area will be measured planimetrically. Tricuspid regurgitation velocity will be obtained using continuous-wave Doppler. Inferior vena cava diameter and inspiratory collapse will be assessed to estimate right atrial pressure according to guideline recommendations. Pulmonary artery systolic pressure will be calculated using the modified Bernoulli equation (4×TRV² + RAP). In the absence of right ventricular outflow tract obstruction, PASP will be accepted as equivalent to right ventricular systolic pressure.
Right ventricular-pulmonary artery coupling will be calculated using:
TAPSE/PASP
Tricuspid S'/PASP
FAC/PASP ratios
Patients with advanced primary valvular disease (moderate/severe mitral stenosis, severe primary mitral regurgitation defined by vena contracta ≥7 mm or EROA ≥40 mm², significant aortic stenosis defined by AVA ≤1.5 cm² or mean gradient ≥20 mmHg, or significant aortic regurgitation defined by vena contracta ≥6 mm or PHT <200 ms) will be excluded. Patients with primary right heart disease or suboptimal imaging quality will also be excluded.
In-Hospital Evaluation
Initial intravenous diuretic dose will be recorded. Patients will be classified according to whether the administered intravenous dose is at least twice the pre-admission oral diuretic dose.
In-hospital clinical events including mechanical ventilation requirement, vasopressor or inotropic support, development of acute kidney injury, and in-hospital mortality will be prospectively recorded. Length of stay will be defined as the interval between admission and discharge.
BNP levels at admission and discharge will be recorded, and percentage change will be calculated. Patients will be categorized according to >30% reduction, no significant reduction, or increase in BNP levels.
Follow-Up
The discharge date will be defined as Day 0 for follow-up. Patients will be prospectively followed for up to 15 months using hospital electronic records. Event time will be calculated from discharge to cardiovascular death or heart failure-related rehospitalization.
Statistical Analysis
Statistical analyses will be performed using SPSS version 25. Normality will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Continuous variables will be expressed as mean ± SD or median (min-max) as appropriate. Categorical variables will be expressed as n (%).
Group comparisons will be performed using chi-square tests, Mann-Whitney U tests, Pearson or Spearman correlation analyses as appropriate. Time-to-event outcomes will be analyzed using Kaplan-Meier survival curves and compared using log-rank tests. Independent predictors will be identified using univariable and multivariable Cox proportional hazards regression models. In-hospital binary outcomes will be evaluated using logistic regression analysis. Receiver operating characteristic curve analysis will be used to determine optimal prognostic cut-off values. A two-sided p-value <0.05 will be considered statistically significant.
The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Istanbul University-Cerrahpaşa Non-Interventional Clinical Research Ethics Committee (Approval No: 2024/251). Written informed consent will be obtained from all participants.
- Conditions
- Heart Failure
- Keywords
- heart failure, Acute Decompensated Heart Failure, Heart Failure Hospitalization, Transthoracic Echocardiography, RV-PA Coupling, TAPSE/PASP, Pulmonary Artery Systolic Pressure, Prognosis, BNP, Echocardiographic Predictors of Outcomes in Heart Failure, Predictors of Clinical Outcomes in Heart Failure
- 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 |
|---|---|---|
| Hospitalized Decompensated Heart Failure Cohort | Patients aged 18 years or older who present to the emergency department or the cardiology outpatient clinic with decompensated heart failure and are determined by a cardiologist to require intravenous diuretic therapy and hospital admission. A transthoracic echocardiogram (TTE) is performed prior to the first dose of diuretic therapy. Patients are classified as having HFrEF, HFmrEF, or HFpEF according to chronic heart failure guideline definitions and are included if no exclusion criteria apply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Cardiovascular Death or Heart Failure-Related Rehospitalization
Time to first occurrence of the composite endpoint of cardiovascular death after hospital discharge or heart failure-related rehospitalization. Event time will be calculated from the date of hospital discharge (Day 0) to the first documented event during follow-up.
Measured: From the date of hospital discharge (Day 0) until the first occurrence of cardiovascular death or heart failure-related rehospitalization, assessed up to 15 months.
Secondary outcomes (4)
Need for Non-Invasive or Invasive Mechanical Ventilation During Hospitalization
The need for non-invasive mechanical ventilation or invasive mechanical ventilation during the index hospitalization will be recorded and reported as a secondary outcome.
Measured: From hospital admission until discharge during index hospitalization (up to 20 days).
Need for Inotropic or Vasopressor Support During Hospitalization
The requirement for inotropic or vasopressor support at any time from hospital admission to discharge during the index hospitalization will be recorded as a secondary outcome.
Measured: From hospital admission until discharge during index hospitalization (up to 20 days).
Development of Acute Kidney Injury During Hospitalization
Development of acute kidney injury from hospital admission to discharge during the index hospitalization will be recorded as a secondary outcome.
Measured: From hospital admission until discharge during index hospitalization (up to 20 days).
In-Hospital Mortality During Index Hospitalization
Occurrence of all-cause death during the index hospitalization (from hospital admission to discharge) will be recorded as a secondary outcome.
Measured: From hospital admission until discharge during index hospitalization (up to 20 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Mar 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (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.
- More trials run by Istanbul University - CerrahpasaThe 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
- 76 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Gül, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439159
- Sponsor's protocol ID
- E-74555795-050.04-1210556
- Acronym
- ECHO-DECOMP
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Transthoracic Echocardiographic Predictors of Recurrent Hospitalization and Survival in Patients Hospitalized Due to Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07439159
- Acronym / sponsor ID
- ECHO-DECOMP / E-74555795-050.04-1210556
- Conditions
- Heart Failure
- Keywords
- heart failure, Acute Decompensated Heart Failure, Heart Failure Hospitalization, Transthoracic Echocardiography, RV-PA Coupling, TAPSE/PASP, Pulmonary Artery Systolic Pressure, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Feb 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.
Acute decompensated heart failure is a leading cause of hospitalization and is associated with high morbidity and mortality. Early risk stratification in this population is crucial for guiding treatment strategies and predicting short- and long-term clinical outcomes. Transthoracic echocardiography is routinely performed in patients hospitalized with acute decompensated heart failure and provides comprehensive information regarding cardiac structure and function. However, the prognostic value of detailed echocardiographic parameters obtained before the initiation of intravenous diuretic therapy has not been fully clarified.
The objective of this prospective study is to evaluate the prognostic significance of transthoracic echocardiographic findings obtained at hospital admission, prior to intravenous diuretic therapy, in patients hospitalized with acute decompensated heart failure. The study will assess key echocardiographic parameters reflecting left and right heart structure and function, including left ventricular ejection fraction, left ventricular dimensions and geometry, left atrial size and volume, indices of right ventricular systolic function (such as TAPSE, tissue Doppler-derived S' velocity, and fractional area change), pulmonary artery systolic pressure, right ventricular-pulmonary artery coupling assessed by the TAPSE/PASP ratio, and right ventricular outflow tract acceleration time.
Primary outcome measures include in-hospital mortality, post-discharge mortality, myocardial infarction, ischemic stroke, and heart failure-related rehospitalization. Secondary outcomes include the need for non-invasive or invasive mechanical ventilation during hospitalization, requirement for inotropic support, changes in B-type natriuretic peptide levels, development of acute kidney injury, and occurrence of new-onset cardiac arrhythmias.
By prospectively evaluating echocardiographic parameters and their associations with clinical outcomes, this study aims to clarify the prognostic role of early echocardiographic assessment in acute decompensated heart failure and to contribute to improved risk stratification and clinical decision-making in this high-risk population.
Detailed description
This study will be designed as a prospective, single-center, observational investigation conducted at Istanbul University-Cerrahpaşa Cardiology Institute between December 2024 and December 2025. Based on an a priori power analysis performed using G*Power software for linear regression modeling, assuming a two-sided alpha error of 0.05 and 80% statistical power, a minimum of 76 patients will be required for adequate statistical validity.
Study Population
Consecutive adult patients presenting to the emergency department or outpatient cardiology clinic and hospitalized for acute decompensated heart failure following independent cardiologist evaluation and indication for intravenous diuretic therapy will be enrolled. Patients will be evaluated by the study investigator after admission and prior to the first intravenous diuretic administration.
Demographic variables (age, sex), anthropometric measurements (height, weight), body mass index calculated using the Quetelet formula (kg/m²), and body surface area calculated using the Mosteller formula (m²) will be recorded. Vital signs including systolic and diastolic blood pressure (mmHg), peripheral oxygen saturation (%), and heart rate (beats per minute) will be documented.
Comorbidities including hypertension, diabetes mellitus, atrial fibrillation, ischemic heart disease, chronic obstructive pulmonary disease, chronic kidney disease, hypothyroidism, ischemic cerebrovascular disease, peripheral arterial disease, and smoking status will be recorded.
Functional capacity will be evaluated according to the New York Heart Association (NYHA) classification.
Electrocardiographic Evaluation
Standard 12-lead electrocardiography will be obtained in the supine resting position at 25 mm/s speed and 10 mm/mV calibration. Rhythm will be categorized as sinus rhythm or atrial fibrillation. QRS duration will be measured from the onset of the Q wave to the end of the S wave in the lead demonstrating the widest morphology and recorded both as a continuous variable (ms) and categorized using a 120 ms threshold.
Heart Failure Classification and Medical Therapy
Heart failure etiology will be classified as ischemic or non-ischemic in previously diagnosed patients. In newly diagnosed cases, presumed etiology will be recorded at baseline and updated when definitive diagnosis is established.
Patients will be categorized according to ESC and ACC/AHA guideline-recommended left ventricular ejection fraction classifications:
HFrEF (EF <40%)
HFmrEF (EF 40-49%)
HFpEF (EF ≥50%)
Baseline medical therapy will be recorded, including the number and type of guideline-directed medical therapy (GDMT) agents. High-dose diuretic therapy will be defined as ≥80 mg/day for furosemide or ≥20 mg/day for torasemide. Combination diuretic therapy (loop plus thiazide or thiazide-like diuretic) will be documented. Presence of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) will be recorded.
Precipitating Factors
Potential precipitating factors for decompensation including atrial fibrillation with rapid ventricular response (defined as AF with resting ventricular rate ≥110 bpm), infection (defined by elevated CRP, leukocytosis, procalcitonin elevation, and compatible clinical findings), and acute kidney injury (defined according to KDIGO criteria) will be documented.
Laboratory Assessment
Admission laboratory parameters obtained without intervention will be extracted from the hospital information system and will include BUN, creatinine, estimated glomerular filtration rate (eGFR), sodium, potassium, AST, ALT, hemoglobin, hematocrit, white blood cell count, platelet count, HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, CRP, and B-type natriuretic peptide (BNP).
Patients with severe anemia (hemoglobin <7 g/dL) or receiving chronic dialysis therapy will be excluded.
Transthoracic Echocardiography
Comprehensive transthoracic echocardiography will be performed prior to intravenous diuretic therapy using a Philips EPIQ 7C ultrasound system equipped with an S5-1 phased-array transducer.
Patients will be examined in the left lateral decubitus position with ECG synchronization. In sinus rhythm, three consecutive cardiac cycles will be averaged; in atrial fibrillation, five consecutive cycles will be averaged.
Parasternal long-axis (PLAX), parasternal short-axis (PSAX), apical four-chamber (A4C), apical five-chamber (A5C), and apical two-chamber (A2C) views will be obtained.
Left ventricular ejection fraction will be calculated primarily using the biplane Simpson method. Left ventricular mass will be calculated using the Devereux formula and indexed to body surface area. Relative wall thickness and left ventricular eccentricity index (D2/D1 ratio) will be calculated.
Right ventricular systolic function will be assessed using:
Tricuspid annular plane systolic excursion (TAPSE)
Tissue Doppler-derived tricuspid annular systolic velocity (S')
Right ventricular fractional area change (FAC)
Right atrial area will be measured planimetrically. Tricuspid regurgitation velocity will be obtained using continuous-wave Doppler. Inferior vena cava diameter and inspiratory collapse will be assessed to estimate right atrial pressure according to guideline recommendations. Pulmonary artery systolic pressure will be calculated using the modified Bernoulli equation (4×TRV² + RAP). In the absence of right ventricular outflow tract obstruction, PASP will be accepted as equivalent to right ventricular systolic pressure.
Right ventricular-pulmonary artery coupling will be calculated using:
TAPSE/PASP
Tricuspid S'/PASP
FAC/PASP ratios
Patients with advanced primary valvular disease (moderate/severe mitral stenosis, severe primary mitral regurgitation defined by vena contracta ≥7 mm or EROA ≥40 mm², significant aortic stenosis defined by AVA ≤1.5 cm² or mean gradient ≥20 mmHg, or significant aortic regurgitation defined by vena contracta ≥6 mm or PHT <200 ms) will be excluded. Patients with primary right heart disease or suboptimal imaging quality will also be excluded.
In-Hospital Evaluation
Initial intravenous diuretic dose will be recorded. Patients will be classified according to whether the administered intravenous dose is at least twice the pre-admission oral diuretic dose.
In-hospital clinical events including mechanical ventilation requirement, vasopressor or inotropic support, development of acute kidney injury, and in-hospital mortality will be prospectively recorded. Length of stay will be defined as the interval between admission and discharge.
BNP levels at admission and discharge will be recorded, and percentage change will be calculated. Patients will be categorized according to >30% reduction, no significant reduction, or increase in BNP levels.
Follow-Up
The discharge date will be defined as Day 0 for follow-up. Patients will be prospectively followed for up to 15 months using hospital electronic records. Event time will be calculated from discharge to cardiovascular death or heart failure-related rehospitalization.
Statistical Analysis
Statistical analyses will be performed using SPSS version 25. Normality will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Continuous variables will be expressed as mean ± SD or median (min-max) as appropriate. Categorical variables will be expressed as n (%).
Group comparisons will be performed using chi-square tests, Mann-Whitney U tests, Pearson or Spearman correlation analyses as appropriate. Time-to-event outcomes will be analyzed using Kaplan-Meier survival curves and compared using log-rank tests. Independent predictors will be identified using univariable and multivariable Cox proportional hazards regression models. In-hospital binary outcomes will be evaluated using logistic regression analysis. Receiver operating characteristic curve analysis will be used to determine optimal prognostic cut-off values. A two-sided p-value <0.05 will be considered statistically significant.
The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Istanbul University-Cerrahpaşa Non-Interventional Clinical Research Ethics Committee (Approval No: 2024/251). Written informed consent will be obtained from all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Decompensated Heart Failure Cohort | – | –Patients aged 18 years or older who present to the emergency department or the cardiology outpatient clinic with decompensated heart failure and are determined by a cardiologist to require intravenous diuretic therapy and hospital admission. A transthoracic echocardiogram (TTE) is performed prior to the first dose of diuretic therapy. Patients are classified as having HFrEF, HFmrEF, or HFpEF according to chronic heart failure guideline definitions and are included if no exclusion criteria apply |
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 consist of adult patients hospitalized for acute decompensated heart failure at Istanbul University-Cerrahpaşa Cardiology Institute Hospital. Participants will be selected from patients presenting to the emergency department or cardiology outpatient clinics who require inpatient management for heart failure decompensation.
Key inclusion criteria (5 listed)
- Adults aged ≥18 years.
- Hospitalization due to acute decompensated heart failure.
- Intravenous diuretic therapy deemed necessary by the treating cardiologist.
- Predominant left-sided heart failure.
- Provision of written informed consent prior to participation.
Key exclusion criteria (15 listed)
- Severe anemia (hemoglobin <7 g/dL).
- Requirement for renal replacement therapy, including hemodialysis or peritoneal dialysis, or being listed for kidney transplantation.
- Severe primary mitral regurgitation.
- Severe aortic stenosis.
- Severe aortic regurgitation.
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
Time to Cardiovascular Death or Heart Failure-Related Rehospitalization
Time frame: From the date of hospital discharge (Day 0) until the first occurrence of cardiovascular death or heart failure-related rehospitalization, assessed up to 15 months.
Time to first occurrence of the composite endpoint of cardiovascular death after hospital discharge or heart failure-related rehospitalization. Event time will be calculated from the date of hospital discharge (Day 0) to the first documented event during follow-up.
4 secondary outcomes
Need for Non-Invasive or Invasive Mechanical Ventilation During Hospitalization
Time frame: From hospital admission until discharge during index hospitalization (up to 20 days).
Need for Inotropic or Vasopressor Support During Hospitalization
Time frame: From hospital admission until discharge during index hospitalization (up to 20 days).
Development of Acute Kidney Injury During Hospitalization
Time frame: From hospital admission until discharge during index hospitalization (up to 20 days).
In-Hospital Mortality During Index Hospitalization
Time frame: From hospital admission until discharge during index hospitalization (up to 20 days).
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 27 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 15 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 27 Feb 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 Turkey (Türkiye). 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 Aybike G Taşdelen Acar, MD (+905356955610, aybikegul.tasdelen@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Cardiovascular Death or Heart Failure-Related Rehospitalization (time frame: From the date of hospital discharge (Day 0) until the first occurrence of cardiovascular death or heart failure-related rehospitalization, assessed up to 15 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 27 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.