Heart FailureU-SCREEN-HFNCT06940544
Uppsala Self-SCREENing of Heart Failure Study
A study testing Stepwise Multimodal Home-Based HF Screening in people with Heart Failure, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Stepwise Multimodal Home-Based HF Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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)
Who cannot join
- Previous diagnosis of HF
- Previous renal replacement therapy
- Inability to comply with study procedures or provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala Akademiska Hospital
Uppsala
Johan Sundström, MD, PhD, 0046186110000, johan.sundstrom@uu.se
About this study
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:
Read more
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
- Being tested
- Stepwise Multimodal Home-Based HF Screening
- Keywords
- Heart Failure, Home-based screening, Point-of-care testing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise Multimodal Home-Based HF ScreeningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| SCREENING Arm | Experimental | Home-Based HF Screening with NTproBNP and AI-Assisted Echocardiography Receives: Diagnostic Test: Stepwise Multimodal Home-Based HF Screening |
| CONTROL Arm | No intervention | Usual Care Without Systematic HF Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of undiagnosed heart failure (HF) in high-risk patients.
Diagnosis of HF; HF is defined as either:
- an outpatient diagnosis of heart failure according to the ESC 2021 Heart Failure Guidelines,
- outpatient heart failure visit,
- an urgent heart failure visit, or
- a heart failure hospitalisation.
Measured: Within 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Feb 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940544
- Sponsor's protocol ID
- 2022-06248-01
- Acronym
- U-SCREEN-HF
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of certain IPD may be prohibited for ethical reasons.
Publications
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.
PubMed 22888160Packer 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.
PubMed 31849132Tromp 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.
PubMed 34863649Jorgensen 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):515-25.
PubMed 22783583McDonagh 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.
PubMed 34447992Sundstrom 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.
PubMed 30265168Goldman 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.
PubMed 7296795Homar 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.
PubMed 32200491Ontario 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.
PubMed 34055110Mant 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.
PubMed 19586584Thorstensen 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.
PubMed 19959533Nagueh 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.
PubMed 30632389Ezekowitz 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.
PubMed 20959343Conrad 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.
PubMed 31112552Koudstaal 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.
PubMed 28008698
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uppsala Self-SCREENing of Heart Failure Study
- ClinicalTrials.gov ID
- NCT06940544
- Acronym / sponsor ID
- U-SCREEN-HF / 2022-06248-01
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Home-based screening, Point-of-care testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCREENING Arm | Experimental | Diagnostic Test: Stepwise Multimodal Home-Based HF ScreeningHome-Based HF Screening with NTproBNP and AI-Assisted Echocardiography |
| CONTROL Arm | No intervention | –Usual Care Without Systematic HF Screening |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (3 listed)
- Previous diagnosis of HF
- Previous renal replacement therapy
- Inability to comply with study procedures or provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepwise Multimodal Home-Based HF ScreeningThe 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. | Diagnostic test | SCREENING Arm |
Primary outcome
Detection of undiagnosed heart failure (HF) in high-risk patients.
Time frame: Within 6 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Background: PubMed 22888160McGrady 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.
- Background: PubMed 31849132Packer 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.
- Background: PubMed 34863649Tromp 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.
- Background: PubMed 22783583Jorgensen 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):515-25.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 30265168Sundstrom 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.
- Background: PubMed 7296795Goldman 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.
- Background: PubMed 32200491Homar 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.
- Background: PubMed 34055110Ontario 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.
- Background: PubMed 19586584Mant 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.
- Background: PubMed 19959533Thorstensen 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.
- Background: PubMed 30632389Nagueh 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.
- Digital consent platform with current version of participant information, and possibility to consent to the study during the recruitment periodLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sharing of certain IPD may be prohibited for ethical reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise Multimodal Home-Based HF Screening in people with Heart Failure, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of undiagnosed heart failure (HF) in high-risk patients. (time frame: Within 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940544, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.