Improving Diagnostic Accuracy for Acute Heart Failure

NCT04886128 | Active Not Recruiting

• 1 other identifier: 210941
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

Acute heart failure is a common reason for emergency department visits and hospitalization, but the diagnosis can be challenging because of non-specific symptoms and signs. The current diagnostic approach to acute heart failure has modest accuracy, leading to delayed diagnosis and treatment, which associate with worse prognosis. Prior work suggests diagnostic accuracy can be improved with the addition of multiple circulating biomarkers discovered through proteomics, and this study will derive and validate a multi-marker model to improve diagnostic accuracy for acute heart failure in the emergency department.

Conditions

Acute Heart Failure; Dyspnea; Dyspnea; Cardiac

Keywords

heart failure; acute heart failure

Outcome Measures

Primary Outcomes (3)

• Biomarker Discovery

  Define the multi-marker panel of 21 proteins that may improve diagnostic accuracy for acute heart failure

  Enrollment

• Model derivation for diagnosing acute HF

  derive a model for diagnosing acute HF incorporating the 21-biomarker panel from outcome 1

  Enrollment

• Model validation for diagnosing acute HF

  test performance of the multi-marker model (from outcome 2) in a prospective validation cohort

  Enrollment

Study Arms (3)

Aim 1/Outcome 1

Secondary analysis of frozen plasma samples from the existing STRATIFY cohort of patients with and without acute heart failure presenting to emergency departments. n= \~900

Aim2/Outcome 2

Secondary analysis of frozen plasma samples from the existing EMROC cohort of patients with and without acute heart failure presenting to emergency departments. n= \~900

Aim 3/Outcome 3

Prospective recruitment of approximately 1000 patients with and w/o acute heart failure presenting to emergency departments.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18 years or older) presenting with the chief complaint of dyspnea and in whom the ED physician is considering the diagnosis of acute HF, based on an order for measurement of NP levels (either BNP or NT-proBNP) or a chest x-ray will be included. Patients whose dyspnea is due to trauma, those who are on chronic hemodialysis, and patients whose primary presentation is consistent with acute coronary syndrome will be excluded.

You may qualify if:

• Willing to adhere to the study protocol
• Able to provide written consent
• English or Spanish speaking
• Adult, defined as 18 years or older
• Primary reason for presentation to the ED is dyspnea
• ED physician is considering a diagnosis of HF, defined by ordering a NP test and/or a chest x-ray

You may not qualify if:

• History of end-stage renal disease for which hemodialysis is needed
• Dyspnea due to primary presentation of an acute coronary syndrome or trauma

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Wayne State University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, whole blood, and urine samples will be retained. For the primary aims, plasma will be used.

MeSH Terms

Conditions

Dyspnea; Heart Failure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Deepak Gupta, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: August 31, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)