NCT07439159

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Mar 2024Aug 2027

Study Start

First participant enrolled

March 3, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

January 18, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

heart failureAcute Decompensated Heart FailureHeart Failure HospitalizationTransthoracic EchocardiographyRV-PA CouplingTAPSE/PASPPulmonary Artery Systolic PressurePrognosisBNPEchocardiographic Predictors of Outcomes in Heart FailurePredictors of Clinical Outcomes in Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From hospital admission until discharge during index hospitalization (up to 20 days).

  • Need for Inotropic or Vasopressor Support During Hospitalization

    From hospital admission until discharge during index hospitalization (up to 20 days).

  • Development of Acute Kidney Injury During Hospitalization

    From hospital admission until discharge during index hospitalization (up to 20 days).

  • In-Hospital Mortality During Index Hospitalization

    From hospital admission until discharge during index hospitalization (up to 20 days).

Other Outcomes (1)

  • All-Cause Mortality Through Follow-up (In-Hospital and Post-Discharge)

    From the date of index hospitalization admission until death from any cause, assessed up to 15 months after hospital discharge.

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa Institute of Cardiology

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Aybike G Taşdelen Acar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESİDENT İN CARDIOLOGY

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 27, 2026

Study Start

March 3, 2024

Primary Completion

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations