Study Results
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Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2023-02-01
2026-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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SCREENING Arm
Home-Based HF Screening with NTproBNP and AI-Assisted Echocardiography
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.
CONTROL Arm
Usual Care Without Systematic HF Screening
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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 renal replacement therapy
* Inability to comply with study procedures or provide informed consent
40 Years
ALL
Yes
Sponsors
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Uppsala University
OTHER
Responsible Party
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Locations
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Uppsala Akademiska Hospital
Uppsala, , Sweden
Countries
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Facility Contacts
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References
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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.
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.
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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 Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
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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.
Ontario Health (Quality). Use of B-Type Natriuretic Peptide (BNP) and N-Terminal proBNP (NT-proBNP) as Diagnostic Tests in Adults With Suspected Heart Failure: A Health Technology Assessment. Ont Health Technol Assess Ser. 2021 May 6;21(2):1-125. eCollection 2021.
Mant J, Doust J, Roalfe A, Barton P, Cowie MR, Glasziou P, Mant D, McManus RJ, Holder R, Deeks J, Fletcher K, Qume M, Sohanpal S, Sanders S, Hobbs FD. Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess. 2009 Jul;13(32):1-207, iii. doi: 10.3310/hta13320.
Thorstensen A, Dalen H, Amundsen BH, Aase SA, Stoylen A. Reproducibility in echocardiographic assessment of the left ventricular global and regional function, the HUNT study. Eur J Echocardiogr. 2010 Mar;11(2):149-56. doi: 10.1093/ejechocard/jep188. Epub 2009 Dec 3.
Nagueh SF, Abraham TP, Aurigemma GP, Bax JJ, Beladan C, Browning A, Chamsi-Pasha MA, Delgado V, Derumeaux G, Dolci G, Donal E, Edvardsen T, El Tallawi KC, Ernande L, Esposito R, Flachskampf FA, Galderisi M, Gentry J, Goldstein SA, Harb SC, Hubert A, Hung J, Klein AL, Lancellotti P, Mahmood RZ, Marino P, Popescu BA, Previato M, Sanghai SR, Smiseth OA, Xu J; for Diastolic Function Assessment Collaborators. Interobserver Variability in Applying American Society of Echocardiography/European Association of Cardiovascular Imaging 2016 Guidelines for Estimation of Left Ventricular Filling Pressure. Circ Cardiovasc Imaging. 2019 Dec;12(1):e008122. doi: 10.1161/CIRCIMAGING.118.008122.
Ezekowitz JA, Kaul P, Bakal JA, Quan H, McAlister FA. Trends in heart failure care: has the incident diagnosis of heart failure shifted from the hospital to the emergency department and outpatient clinics? Eur J Heart Fail. 2011 Feb;13(2):142-7. doi: 10.1093/eurjhf/hfq185. Epub 2010 Oct 19.
Conrad N, Judge A, Canoy D, Tran J, O'Donnell J, Nazarzadeh M, Salimi-Khorshidi G, Hobbs FDR, Cleland JG, McMurray JJV, Rahimi K. Diagnostic tests, drug prescriptions, and follow-up patterns after incident heart failure: A cohort study of 93,000 UK patients. PLoS Med. 2019 May 21;16(5):e1002805. doi: 10.1371/journal.pmed.1002805. eCollection 2019 May.
Koudstaal S, Pujades-Rodriguez M, Denaxas S, Gho JMIH, Shah AD, Yu N, Patel RS, Gale CP, Hoes AW, Cleland JG, Asselbergs FW, Hemingway H. Prognostic burden of heart failure recorded in primary care, acute hospital admissions, or both: a population-based linked electronic health record cohort study in 2.1 million people. Eur J Heart Fail. 2017 Sep;19(9):1119-1127. doi: 10.1002/ejhf.709. Epub 2016 Dec 23.
van Riet EE, Hoes AW, Limburg A, Landman MA, van der Hoeven H, Rutten FH. Prevalence of unrecognized heart failure in older persons with shortness of breath on exertion. Eur J Heart Fail. 2014 Jul;16(7):772-7. doi: 10.1002/ejhf.110. Epub 2014 May 26.
Bottle A, Kim D, Aylin P, Cowie MR, Majeed A, Hayhoe B. Routes to diagnosis of heart failure: observational study using linked data in England. Heart. 2018 Apr;104(7):600-605. doi: 10.1136/heartjnl-2017-312183. Epub 2017 Oct 5.
Braunwald E. The war against heart failure: the Lancet lecture. Lancet. 2015 Feb 28;385(9970):812-24. doi: 10.1016/S0140-6736(14)61889-4. Epub 2014 Nov 16.
Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
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Bragazzi NL, Zhong W, Shu J, Abu Much A, Lotan D, Grupper A, Younis A, Dai H. Burden of heart failure and underlying causes in 195 countries and territories from 1990 to 2017. Eur J Prev Cardiol. 2021 Dec 29;28(15):1682-1690. doi: 10.1093/eurjpc/zwaa147.
Related Links
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Digital consent platform with current version of participant information, and possibility to consent to the study during the recruitment period
Other Identifiers
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2022-06248-01
Identifier Type: -
Identifier Source: org_study_id
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