Uppsala Self-SCREENing of Heart Failure Study

Summary

The goal of this clinical trial is to investigate whether a stepwise multimodal home-based screening strategy with rapid point-of-care testing can detect undiagnosed heart failure (HF) in high-risk patients compared to usual care. The study also aims to understand the impact of earlier HF diagnosis on treatment initiation, clinical outcomes, symptoms, functional capacity, health-related quality of life, healthcare utilization, and costs.

The main questions it aims to answer are:

Does a home-based screening strategy increase the diagnosis of HF within 6 months compared to usual care?

Does earlier diagnosis lead to more patients receiving guideline-directed medical therapy (GDMT) for HF with reduced ejection fraction (HFrEF) within 6 months?

What is the impact of this screening strategy on HF hospitalizations, mortality, functional capacity, health-related quality of life, and healthcare costs over 1, 2, and 5 years?

Researchers will compare a stepwise multimodal home-based screening strategy to usual care to determine if the screening strategy leads to earlier HF diagnosis and improved patient outcomes.

Participants will:

Provide dried blood spot samples for NTproBNP analysis by mail.

If NTproBNP is elevated (≥125 pg/ml), undergo point-of-care NTproBNP testing and an AI-enabled echocardiogram.

Be followed for up to 5 years through healthcare databases and self-reported symptom monitoring to track HF diagnosis, treatment initiation, clinical outcomes, and healthcare utilization.

The study will randomize 500 high-risk participants in a 1:1 ratio to either the ACTIVE arm (home-based screening) or the CONTROL arm (usual care). Participants with known HF are excluded.

The primary outcome is the diagnosis of HF within 6 months. Secondary outcomes include the diagnosis of HFrEF and initiation of GDMT within 6 months. Exploratory outcomes will assess long-term clinical outcomes (HF hospitalizations and death), functional capacity, quality of life, and cost-effectiveness at 1, 2, and 5 years.

This investigator-initiated trial is part of the international SYMPHONY study and is coordinated from Uppsala University and Uppsala University Hospital, Sweden. The study will use healthcare databases, registries, and digital resources for comprehensive outcome capture. The first patient visit is scheduled for February 1, 2023, with follow-up extending to August 2026 for the primary outcome and up to 5 years for exploratory outcomes.

Conditions

• Heart Failure

Interventions

DIAGNOSTIC_TEST

Stepwise Multimodal Home-Based HF Screening

The Stepwise Multimodal Home-Based HF Screening intervention involves a targeted community outreach program to identify undiagnosed heart failure (HF) in high-risk individuals. Participants randomized to the intervention arm (ACTIVE) are asked to self-collect dried blood spots for NTproBNP analysis. Those with elevated NTproBNP (≥125 pg/ml) in the dried blood spots are summoned to the study clinic and undergo confirmatory point-of-care NTproBNP testing and an AI-enabled echocardiogram, with the aim to confirm or rule out heart failure.

Sponsors & Collaborators

• Uppsala University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2026-08-01

Completion

2026-08-01

Countries

• Sweden

Study Locations