Uppsala Self-SCREENing of Heart Failure Study

Обзор

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Detection of undiagnosed heart failure (HF) in high-risk patients. [Срок оценки: Within 6 months.]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Швеция · 1 центр

• Uppsala Akademiska Hospital — Uppsala

Публикации

• McGrady M, Krum H, Carrington MJ, Stewart S, Zeitz C, Lee GA, Marwick TH, Haluska BA, Brown A. Heart failure, ventricular dysfunction and risk factor prevalence in Australian Aboriginal peoples: the Heart of the Heart Study. Heart. 2012 Nov;98(21):1562-7. doi: 10.1136/heartjnl-2012-302229. Epub 2012 Aug 11. PMID 22888160
• Packer M. Do most patients with obesity or type 2 diabetes, and atrial fibrillation, also have undiagnosed heart failure? A critical conceptual framework for understanding mechanisms and improving diagnosis and treatment. Eur J Heart Fail. 2020 Feb;22(2):214-227. doi: 10.1002/ejhf.1646. Epub 2019 Dec 17. PMID 31849132
• Tromp J, Seekings PJ, Hung CL, Iversen MB, Frost MJ, Ouwerkerk W, Jiang Z, Eisenhaber F, Goh RSM, Zhao H, Huang W, Ling LH, Sim D, Cozzone P, Richards AM, Lee HK, Solomon SD, Lam CSP, Ezekowitz JA. Automated interpretation of systolic and diastolic function on the echocardiogram: a multicohort study. Lancet Digit Health. 2022 Jan;4(1):e46-e54. doi: 10.1016/S2589-7500(21)00235-1. Epub 2021 Dec 1. PMID 34863649
• Jorgensen B, Bertsch T, Broker HJ, Schafer M, Chapelle JP, Gadisseur R, Cowie MR, Dikkeschei B, Gurr E, Hayen W, Hafner G, Stiegler Y, Schonherr HR, Strasser RH, Weidtmann B, Folkerts H, Zugck C, Hofmann K, Zerback R. Multicentre evaluation of a second generation point-of-care assay with an extended range for the determination of N-terminal pro-brain natriuretic peptide. Clin Lab. 2012;58(5-6):515 PMID 22783583
• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Gro PMID 34447992
• Sundstrom J, Lind L, Nowrouzi S, Lytsy P, Marttala K, Ekman I, Ohagen P, Ostlund O. The Precision HYpertenSIon Care (PHYSIC) study: a double-blind, randomized, repeated cross-over study. Ups J Med Sci. 2019 Jan;124(1):51-58. doi: 10.1080/03009734.2018.1498958. Epub 2018 Sep 28. PMID 30265168
• Goldman L, Hashimoto B, Cook EF, Loscalzo A. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: advantages of a new specific activity scale. Circulation. 1981 Dec;64(6):1227-34. doi: 10.1161/01.cir.64.6.1227. PMID 7296795
• Homar V, Mirosevic S, Svab I, Lainscak M. Natriuretic peptides for heart failure screening in nursing homes: a systematic review. Heart Fail Rev. 2021 Sep;26(5):1131-1140. doi: 10.1007/s10741-020-09944-w. PMID 32200491

Идентификаторы

NCT: NCT06940544 · 2022-06248-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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