Predicting Heart Failure Outcomes With Biomarkers and Imaging (BIOPHF)

January 26, 2026 updated by: Xiang Xie, Xinjiang Medical University

Blood Biomarkers Combined With Imaging Parameters for Prognostic Assessment in Patients With Different Types of Heart Failure: A Retrospective Single-Center Cohort Study

This study aims to develop a better model to predict one-year risk of death in patients with heart failure. We will test whether combining information from routine blood tests (like NT-proBNP) and heart scans (measuring features like epicardial fat density) improves risk prediction compared to using either type of data alone.

This is a retrospective study using existing medical records of patients treated for chronic heart failure at Xinjiang Medical University First Affiliated Hospital between 2012 and 2024. No new patient contact or interventions are involved.

The goal is to enable more accurate, personalized risk assessment across different types of heart failure (HFrEF, HFmrEF, HFpEF).

Study Overview

Status

Completed

Conditions

Detailed Description

Background and Rationale:

Accurate prognosis in heart failure (HF) remains challenging due to phenotypic heterogeneity across the spectrum of left ventricular ejection fraction (LVEF). While biomarkers like N-terminal pro-B-type natriuretic peptide (NT-proBNP) and imaging parameters like LVEF are standard prognostic tools, each has limitations. Emerging imaging parameters, such as epicardial adipose tissue (EAT) density (reflecting fat inflammation/fibrosis) and left ventricular global longitudinal strain (LVGLS), offer potential incremental prognostic value but are not yet integrated into routine clinical models. This study aims to systematically evaluate whether a multi-parameter model combining established blood biomarkers and advanced imaging metrics improves the prognostic stratification of patients with HFrEF, HFmrEF, and HFpEF compared to traditional approaches.

Detailed Methodology:

This is a single-center, retrospective cohort study. The study population consists of consecutive adult patients (≥18 years) with a confirmed diagnosis of chronic HF who had both qualifying blood biomarker assessment (NT-proBNP and/or high-sensitivity cardiac troponin) and cardiac imaging (transthoracic echocardiography and/or cardiac computed tomography) performed within a ±3-month window around an index encounter between January 1, 2012, and December 31, 2024, at Xinjiang Medical University First Affiliated Hospital.

Key data to be extracted from electronic health records include: 1) Clinical variables: demographics, comorbidities (e.g., ischemic etiology, diabetes, hypertension), medications, and NYHA class; 2) Blood biomarkers: NT-proBNP, hs-cTnT/I, hs-CRP, and renal function (eGFR); 3) Imaging parameters: LVEF, LVGLS, left atrial volume index (LAVI), E/e' ratio, and EAT volume/density (from CT, if available).

The primary endpoint is all-cause mortality at one year from the index date. Follow-up data will be obtained from hospital records.

Statistical Analysis Plan:

The incremental prognostic value will be assessed by constructing and comparing nested Cox proportional hazards models:

Model 1 (Base Clinical): Includes age, sex, BMI, ischemic etiology, diabetes, and hypertension.

Model 2 (Biomarker-Enhanced): Model 1 + NT-proBNP + eGFR. Model 3 (Imaging-Enhanced): Model 2 + key imaging parameters (e.g., EAT density or LVGLS).

Model performance will be compared using Harrell's C-statistic, the Akaike Information Criterion (AIC), Net Reclassification Improvement (NRI), and Integrated Discrimination Improvement (IDI). Pre-specified subgroup analyses will be conducted for HFrEF, HFmrEF, and HFpEF phenotypes. Multiple imputation will be used for variables with low rates of missing data (<10%).

Study Type

Observational

Enrollment (Actual)

4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults diagnosed with chronic heart failure at the study center between 2012 and 2024.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Confirmed diagnosis of chronic heart failure.
  3. Treated at the study center between January 1, 2012, and December 31, 2024.
  4. Availability of both qualifying blood biomarker test results (NT-proBNP and/or high-sensitivity cardiac troponin) and cardiac imaging (echocardiography and/or cardiac CT) performed within a ±3-month window around the index encounter.

Exclusion Criteria:

  1. Heart failure primarily due to severe primary valvular disease, acute myocardial infarction, myocarditis, or pulmonary embolism.
  2. End-stage renal disease requiring dialysis.
  3. Clinical records or follow-up data are severely incomplete, precluding outcome assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart Failure Cohort

Adult patients (≥18 years) with a confirmed diagnosis of chronic heart failure who had both qualifying blood biomarker assessment and cardiac imaging performed within a specified window at the study center between 2012 and 2024.

This is an observational cohort. No specific intervention is administered or withheld as part of the research protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 year
Occurrence of death from any cause within one year (365 days) from the index date. The index date is defined as the date of the first qualifying encounter that meets all inclusion criteria.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phenotype-specific prognostic performance
Time Frame: 1 year
Difference in the predictive performance (measured by Harrell's C-statistic) of the combined biomarker-imaging model across heart failure phenotypes (HFrEF, HFmrEF, HFpEF).
1 year
Independent prognostic value of EAT density in HFpEF
Time Frame: 1 year
Hazard ratio of epicardial adipose tissue (EAT) density for all-cause mortality in HFpEF patients, after adjustment for body mass index (BMI) and high-sensitivity C-reactive protein (hs-CRP).
1 year
Occurrence of HFimpEF
Time Frame: Through study completion,up to 13 years.
The proportion of patients with baseline HFrEF or HFmrEF who achieve HFimpEF, defined as a follow-up LVEF increase by ≥10 percentage points to a value of >40%, assessed by follow-up echocardiography.
Through study completion,up to 13 years.
Association between baseline NT-proBNP level and HFimpEF
Time Frame: Through study completion, up to 13 years.
The association quantified by the Odds Ratio (OR) per unit increase in log-transformed baseline NT-proBNP level with the occurrence of HFimpEF, derived from a multivariable logistic regression model.
Through study completion, up to 13 years.
Association between baseline EAT density and HFimpEF
Time Frame: Through study completion, up to 13 years.
The association quantified by the Odds Ratio (OR) per unit increase in baseline epicardial adipose tissue (EAT) density (in Hounsfield Units) with the occurrence of HFimpEF, derived from a multivariable logistic regression model.
Through study completion, up to 13 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinjiang Medical University

Investigators

  • Study Chair: Xiang Xie, PhD, First Affiliated Hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF_Prognosis_2025
  • K202511-03 (Other Identifier: Xinjiang Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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