Uppsala Self-SCREENing of Heart Failure Study

NCT06940544 | Recruiting

• 1 other identifier: 2022-06248-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart Failure; Home-based screening; Point-of-care testing

Outcome Measures

Primary Outcomes (1)

• Detection of undiagnosed heart failure (HF) in high-risk patients.

  Diagnosis of HF; HF is defined as either: 1. an outpatient diagnosis of heart failure according to the ESC 2021 Heart Failure Guidelines, 2. outpatient heart failure visit, 3. an urgent heart failure visit, or 4. a heart failure hospitalisation.

  Within 6 months.

Study Arms (2)

SCREENING Arm

EXPERIMENTAL

Home-Based HF Screening with NTproBNP and AI-Assisted Echocardiography

Diagnostic Test: Stepwise Multimodal Home-Based HF Screening

CONTROL Arm

NO INTERVENTION

Usual Care Without Systematic HF Screening

Interventions

Stepwise Multimodal Home-Based HF Screening DIAGNOSTIC_TEST

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.

SCREENING Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years, and at least one of the following symptoms of HF, and at least two risk factors for HF:
• Symptoms
• Dyspnoea on exertion
• Dyspnoea at rest
• Orthopnoea
• Paroxysmal nocturnal dyspnoea
• Reduced exercise tolerance, increased time to recover after exercise
• Fatigue, tiredness
• Ankle swelling
• Risk factors
• Diabetes (type 1 or type 2)
• Coronary artery disease (myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention)
• Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
• Previous ischemic or embolic stroke
• Peripheral arterial disease (previous surgical or percutaneous revascularisation)

You may not qualify if:

• Previous diagnosis of HF
• Previous renal replacement therapy
• Inability to comply with study procedures or provide informed consent

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala Akademiska Hospital

Uppsala, Sweden

RECRUITING

Related Publications (21)

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Related Links

• Digital consent platform with current version of participant information, and possibility to consent to the study during the recruitment period

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 23, 2025
• Study Start: February 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

SE (1)