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Early Diagnosis of Heart Failure Using NT-proBNP Levels in Primary Care

NCT07059260 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2025-07-10

No results posted yet for this study

Summary

Heart failure (HF) is a growing public health problem, expected to increase in prevalence and incidence due to population aging. This challenge is compounded by the healthcare overload following the COVID-19 pandemic, particularly in primary care (PC). Early diagnosis of HF is critical for improving outcomes, reducing complications, and optimizing resource use. However, there is no robust scientific evidence supporting the effectiveness of early screening for HF in PC settings.

This study aims to evaluate whether an early cardiology assessment model for patients with suspected HF and elevated NT-proBNP levels (\>300 pg/mL) improves clinical outcomes compared to the standard referral pathway. The hypothesis is that early intervention will reduce emergency visits, hospitalizations, and mortality related to HF.

This is a prospective, single-center, open-label, phase II randomized controlled trial with parallel group allocation (1:1). Patients presenting to PC with HF symptoms and no prior HF diagnosis, who have NT-proBNP levels \>300 pg/mL, will be invited to participate. After informed consent, participants will be randomized to one of two groups:

* Intervention group: Early cardiology assessment within 7 days.
* Control group: Standard referral by PC physician per usual care.

Randomization will be computer-generated and managed independently to ensure allocation concealment. Patients will be followed for 12 months from the date of NT-proBNP testing. Outcomes will be collected through both cardiology and PC visits.

Our primary outcome measure will be the clinical benefit, defined as a hierarchical composite endpoint of:

1. Cardiovascular mortality
2. All-cause mortality
3. Number of hospitalizations due to HF
4. Number of urgent care visits due to HF
5. Number of GDMT (Guideline-Directed Medical Therapy) drugs initiated
6. Number of GDMT drugs with dose escalation
7. Proportional change in log (NT-proBNP) at 12 months

The primary analysis will use a win ratio methodology to maximize statistical efficiency and clinical interpretability.

Secondary outcomes include:

* Each component of the primary endpoint
* Stratified analysis by confirmed or excluded HF diagnosis
* Stratified analysis by HF phenotype (HFrEF vs HFpEF)
* Stratified analysis by sex

A sample size of 304 patients (152 per group) has been calculated to detect a win ratio of 1.7 with 80% power, based on expected clinical benefit and statistical assumptions from prior literature. The study is expected to complete recruitment within 12 months, with a total study duration of 24 months including follow-up and data analysis.

Conditions

Interventions

DIAGNOSTIC_TEST

Early referral

The intervention involves early referral, allowing patients to be assessed by a cardiologist prior to the standard referral process. During this visit, the cardiologist will perform a comprehensive medical history and a detailed physical examination to assess signs of central and peripheral congestion. A standardized echocardiogram will also be conducted, including a series of objective measurements.

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-09-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059260 on ClinicalTrials.gov