Clinical trial NCT06940544: Uppsala Self-SCREENing of Heart Failure Study
Official title: Uppsala Self-SCREENing of Heart Failure Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Home-based screening
Point-of-care testing
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

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)
* Chronic kidney disease
* Regular loop diuretic use (any dose at any dosing interval) for \>30 days
* COPD (diagnosis by respiratory physician, radiological emphysema or treatment with advocated COPD therapy)

Exclusion Criteria:

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

Primary outcomes:
measure: Detection of undiagnosed heart failure (HF) in high-risk patients.
timeFrame: Within 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Hospital
Study officials:
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