NCT06940544: U-SCREEN-HF

Uppsala Self-SCREENing of Heart Failure Study

Recruiting now NA Last updated 23 April 2025

What this trial tests

NA trial testing Stepwise Multimodal Home-Based HF Screening in Heart Failure in 500 participants. Currently enrolling.

Timeline

1 February 2023

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	Uppsala University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	500
Start date	1 February 2023
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across Sweden

Drugs / interventions tested

• Stepwise Multimodal Home-Based HF Screening

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Uppsala University

Who can join

40 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.