Heart FailureSTRONG@HOMENCT06576752
Management of Patients With Heart Failure at Home After Hospital Discharge
A study testing Digital follow-up and uptitration of medications at home after hospital discharge for heart failure and Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure in people with Heart Failure, run by University Hospital, Akershus at 11 sites in Norway.
Trial summary
This study aims to assess whether patients with acute heart failure (HF) can achieve the same level of HF-therapies by digital follow-up at home as compared to hospital visits according to the STRONG-HF strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Digital follow-up and uptitration of medications at home after hospital discharge for heart failure and Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 11 sitesNorway
- Study dates
- 1 Oct 2024to 31 Dec 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital admission within the 72 hours prior to screening for acute HF.
- NT-proBNP ≥ 1,000 pg/mL measured during the hospitalization
- Systolic blood pressure ≥ 100 mmHg and of heart rate ≥ 60 bpm within 24 hours before randomization
- Serum potassium ≤ 5.0 mEq/L (mmol/L).
- ≤ ½ the optimal dose of ACEi/ARB/ARNi or beta-blocker or MRA.
- Written informed consent to participate in the study.
Who cannot join
- Age below 18 or above 85 years.
- Clearly documented intolerance to high doses of beta-blockers
- Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
- Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis.
- Prior (defined as less than 30 days from screening) or current enrollment in a HF intervention or participation in an investigational drug or device study within the 30 days prior to screening
- Index event (admission for acute HF) triggered primarily by a completely reversable etiology so that it is unlikely the patient will be classified with chronic HF after discharge, such as Takotsubo syndrome (stress cardiomyopathy). In the setting of acute coronary syndrome or tachycardia, this should be managed before considering the presence of HF. This does not apply to patients with chronic HF prior to the index event.
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- Severe non-adherence to medications
- Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
- Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patients ability to understand and/or comply with the protocol instructions or follow-up procedures.
- Low digital competency classified as inability to handle a smartphone or tablet.
- Language barriers requiring the need for an external interpreter.
- Pregnant or nursing (lactating) women.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Henrik Schirmer, MD, PhD contact
11 sites in 1 country
Norway11 sites, 11 recruiting
- Recruiting
Ålesund Hospital
Ålesund
Eva Rice, MD, +4770105050, Eva.Rice@helse-mr.no
- Recruiting
Sørlandet Sykehus
Arendal
Jarle Jortveit, MD PhD, +4738073000, jarle.jortveit@gmail.com
- Recruiting
Drammen Hospital, Vestre Viken HF
Drammen, Vestre Viken, 1878
John Munkhaugen, MD PhD, +47 32 80 30 00, johmun@vestreviken.no
- Recruiting
Innlandet sykehus
Hamar
Stine Holmen, MD PhD, +4762333000, b19808@ous-hf.no
- Recruiting
Levanger Sykehus
Levanger
Matthias Lippert, MD PhD, +4774098000, matthias.lippert@helse-nordtrondelag.no
- Recruiting
Akershus University Hospital
Lørenskog, Akershus, 1478
Terjei Øvrebotten, MD, +4767960000, tarjei.ovrebotten@gmail.com
- Recruiting
Østfold Hospital
Moss
Kristin Kvakkestad, MD PhD, +4769860000, kristinturcuta@gmail.com
- Recruiting
Oslo University Hospital
Oslo
Elisabeth Lie, MD PhD, +4723700000, ellie2@ous-hf.no
- Recruiting
Stavanger University Hospital
Stavanger
Stein Ørn, MD PhD, +4751518080, drsteinorn@hotmail.com
- Recruiting
Tønsberg Sykehus
Tønsberg
Erlend Aune, MD PhD, +433342000
- Recruiting
Tromsø University Hospital
Tromsø
Kristina Larsby, MD PhD, +4748075247, kristina.elisabet.larsby@unn.no
About this study
Official title: Contemporary Post-Discharge Management in Heart Failure at Home
This study aims to assess whether patients with acute heart failure (HF) can achieve the same level of HF-therapies by digital follow-up at home as compared to hospital visits according to the STRONG-HF strategy. Patients admitted to hospital with acute HF will be enrolled and randomized to either follow-up at the hospital out-patient clinic or digital follow-up at home.
Read the detailed description
This study seeks to enhance the management of HF patients by demonstrating that follow-up and medication up-titration can be effectively carried out digitally at home, thereby relieving the burden on healthcare systems and patients. There exists a substantial knowledge gap in the implementation of life-saving HF drugs that have been shown to significantly reduce mortality in HF patients, by as much as 73%. Despite strong evidence from clinical trials and guidelines, the utilization of optimal HF therapy among patients remains low. The successful STRONG-HF trial demonstrated improved outcomes through early and rapid up-titration of HF medications and follow-up at specialized HF clinics after discharge, and this strategy is now strongly recommended in the updated European Society of Cardiology Heart Failure Guidelines from 2023. However, a major challenge was the need for patients to travel to the hospital for weekly visits, which posed significant barriers for many patients, especially in geographically dispersed regions due to travel distance, immobility, and logistical challenges. To address this gap, the STRONG@HOME trial aims to conduct visits and rapid up-titration of medications in the patient's home, a strategy not previously tested in a clinical trial and with direct clinical implications. The success of this approach has the potential to improve HF care globally and advance the field of implementation science in HF and other chronic diseases.
- Conditions
- Heart Failure
- Being tested
- Digital follow-up and uptitration of medications at home after hospital discharge for heart failure, Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
- Keywords
- heart failure, digital health, remote monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital follow-up and uptitration of medications at home after hospital discharge for heart failureOther
Also called Dignio (digital healthcare platform), Checkware (digital healthcare platform), Nimble (digital healthcare platform)
Both arms will treat the patients according to the STRONG-HF intensive care strategy, as recommended by current guidelines. That is up-titration to at least half of maximum tolerated doses of HF medications at discharge, followed by up-titration to maximum tolerated doses after 2 weeks. Safety visits will be performed after 1, 3 and 6 weeks.
Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failureOther
Both arms will treat the patients according to the STRONG-HF intensive care strategy, as recommended by current guidelines. That is up-titration to at least half of maximum tolerated doses of HF medications at discharge, followed by up-titration to maximum tolerated doses after 2 weeks. Safety visits will be performed after 1, 3 and 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Home care | Experimental | Follow-up and management of HF medications at home visits after 1, 2, 3 and 6 weeks performed by telecommunication led by HF nurses in close communication with physician at the institution. Around week 2 a single visit to the primary care physician's office is required. Receives: Other: Digital follow-up and uptitration of medications at home after hospital discharge for heart failure |
| Hospital care | Active comparator | Follow-up and management of HF medications provided by specialists at the participating institutions' outpatient clinics after 1, 2, 3 and 6 weeks. (Same as the high-intensity arm in STRONG-HF) Receives: Other: Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline recommended medical treatment Score (0-9)
Patients are assigned a score for each of the four drug classes, and the sum of these is the total score. For beta-blockers and ACEi/ARBs, patients are assigned 0 (no treatment), 1 (<50% target daily dose), or 2 points (≥50% target daily dose) for each therapy. Any dose of ARNI instead of ACEi/ARB are assigned 3 points. Any dose of MRA and SGLT2i are assigned 2 points. Proportion of patients with ≥50% dose of ACEi/ARB/ARNI, MRA and beta blocker and treatment with SGLT2i
Measured: 90 days
Treatment-emergent adverse events
Proportion of patients with eGFR of <30 mL/min/1.73 m2, systolic BP of <95 mm Hg, heart rate of <55 bpm, and serum potassium of >5.0 mmol/L.
Measured: 90 days
Secondary outcomes (18)
Achieved dose in each of the components of the primary endpoint (mg)
Renin-angiotensin-system blockers, mineralocorticoid receptor antagonists and beta blockers, and treatment with sodium-glucose cotransporter-2-inhibitors
Measured: 90 days
Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications
Proportion of patients with ≥50% dose of renin-angiotensin-system blockers, mineralocorticoidreceptor antagonists and beta blockers, and treatment with sodium-glucose cotransporter-2-inhibitors in the subgroup with baseline left ventricular ejection fraction<40%
Measured: 90 days
Change in quality of life by EQ-5D index
Measured by EuroQol Group (EQ-5D) index questionnaire (range 11111 to 55555, higher is worse)
Measured: 90 days
Change in quality of life by EQ-5D VAS
Measured by EuroQol Group (EQ-5D) questionnaire (range 0 to 100, lower is worse)
Measured: 90 days
Change in N-terminal pro-B-type natriuretic peptide (ng/L)
From baseline
Measured: 90 days
Change in echocardiographic measures of left ventricular structure
Left ventricular end diastolic volume index (ml/m^2)
Measured: 90 days
Change in body weight (kg)
From baseline
Measured: 90 days
Self-care
European Heart Failure Self-care Behaviour [EHFScB] scale (range 9-45, higher is worse)
Measured: 90 days
Patient satisfaction with digital follow-up
IT-HEART questionnaire (range 10-50, higher is worse)
Measured: 90 days
Number of heart failure readmissions
Admissions to the hospital for heart failure
Measured: 12 months and 24 months
Number of total readmissions
All admissions to the hospital
Measured: 12 months and 24 months
Time out of hospital
Days not admitted to a hospital after baseline
Measured: 12 months and 24 months
Number of deaths
All-cause mortality
Measured: 12 months and 24 months
Cost
To evaluate the total cost of each follow up strategy by summarizing the cost of healthcare utilization, digital platform costs and travel costs
Measured: 90 days, 12 months, 24 months
Change in HF-specific quality of life
Minnesota Living with HF questionnaire (range 0-105, higher is worse)
Measured: 90 days
Change in echocardiographic measure of cardiac diastolic function
E/e' (ratio)
Measured: 90 days
Change in echocardiographic measure of cardiac systolic function
Left ventricular ejection fraction (%)
Measured: 90 days
Stricter treatment-emergent adverse events
Any of the following events at any of the visits: eGFR of <25 mL/min/1.73 m2, systolic BP of <90 mm Hg, heart rate of <50 bpm, and serum potassium of >5.5 mmol/L
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Peder L. Myhre, MD, PhD, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576752
- Sponsor's protocol ID
- 721190
- Acronym
- STRONG@HOME
- Status last verified
- Jun 2026
- First submitted
- 13 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data
Publications
Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
PubMed 36356631
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Post-Discharge Management in Heart Failure at Home
- ClinicalTrials.gov ID
- NCT06576752
- Acronym / sponsor ID
- STRONG@HOME / 721190
- Conditions
- Heart Failure
- Keywords
- heart failure, digital health, remote monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Aug 2024 (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.
This study aims to assess whether patients with acute heart failure (HF) can achieve the same level of HF-therapies by digital follow-up at home as compared to hospital visits according to the STRONG-HF strategy. Patients admitted to hospital with acute HF will be enrolled and randomized to either follow-up at the hospital out-patient clinic or digital follow-up at home.
Detailed description
This study seeks to enhance the management of HF patients by demonstrating that follow-up and medication up-titration can be effectively carried out digitally at home, thereby relieving the burden on healthcare systems and patients. There exists a substantial knowledge gap in the implementation of life-saving HF drugs that have been shown to significantly reduce mortality in HF patients, by as much as 73%. Despite strong evidence from clinical trials and guidelines, the utilization of optimal HF therapy among patients remains low. The successful STRONG-HF trial demonstrated improved outcomes through early and rapid up-titration of HF medications and follow-up at specialized HF clinics after discharge, and this strategy is now strongly recommended in the updated European Society of Cardiology Heart Failure Guidelines from 2023. However, a major challenge was the need for patients to travel to the hospital for weekly visits, which posed significant barriers for many patients, especially in geographically dispersed regions due to travel distance, immobility, and logistical challenges. To address this gap, the STRONG@HOME trial aims to conduct visits and rapid up-titration of medications in the patient's home, a strategy not previously tested in a clinical trial and with direct clinical implications. The success of this approach has the potential to improve HF care globally and advance the field of implementation science in HF and other chronic diseases.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home care | Experimental | Other: Digital follow-up and uptitration of medications at home after hospital discharge for heart failureFollow-up and management of HF medications at home visits after 1, 2, 3 and 6 weeks performed by telecommunication led by HF nurses in close communication with physician at the institution. Around week 2 a single visit to the primary care physician's office is required. |
| Hospital care | Active comparator | Other: Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failureFollow-up and management of HF medications provided by specialists at the participating institutions' outpatient clinics after 1, 2, 3 and 6 weeks. (Same as the high-intensity arm in STRONG-HF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospital admission within the 72 hours prior to screening for acute HF.
- NT-proBNP ≥ 1,000 pg/mL measured during the hospitalization
- Systolic blood pressure ≥ 100 mmHg and of heart rate ≥ 60 bpm within 24 hours before randomization
- Serum potassium ≤ 5.0 mEq/L (mmol/L).
- ≤ ½ the optimal dose of ACEi/ARB/ARNi or beta-blocker or MRA.
Key exclusion criteria (14 listed)
- Age below 18 or above 85 years.
- Clearly documented intolerance to high doses of beta-blockers
- Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
- Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis.
- Prior (defined as less than 30 days from screening) or current enrollment in a HF intervention or participation in an investigational drug or device study within the 30 days prior to screening
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 |
|---|---|---|
| Digital follow-up and uptitration of medications at home after hospital discharge for heart failureAlso: Dignio (digital healthcare platform), Checkware (digital healthcare platform), Nimble (digital healthcare platform)Both arms will treat the patients according to the STRONG-HF intensive care strategy, as recommended by current guidelines. That is up-titration to at least half of maximum tolerated doses of HF medications at discharge, followed by up-titration to maximum tolerated doses after 2 weeks. Safety visits will be performed after 1, 3 and 6 weeks. | Other | Home care |
| Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failureBoth arms will treat the patients according to the STRONG-HF intensive care strategy, as recommended by current guidelines. That is up-titration to at least half of maximum tolerated doses of HF medications at discharge, followed by up-titration to maximum tolerated doses after 2 weeks. Safety visits will be performed after 1, 3 and 6 weeks. | Other | Hospital care |
Primary outcome
Guideline recommended medical treatment Score (0-9)
Time frame: 90 days
Patients are assigned a score for each of the four drug classes, and the sum of these is the total score. For beta-blockers and ACEi/ARBs, patients are assigned 0 (no treatment), 1 (<50% target daily dose), or 2 points (≥50% target daily dose) for each therapy. Any dose of ARNI instead of ACEi/ARB are assigned 3 points. Any dose of MRA and SGLT2i are assigned 2 points. Proportion of patients with ≥50% dose of ACEi/ARB/ARNI, MRA and beta blocker and treatment with SGLT2i
Treatment-emergent adverse events
Time frame: 90 days
Proportion of patients with eGFR of <30 mL/min/1.73 m2, systolic BP of <95 mm Hg, heart rate of <55 bpm, and serum potassium of >5.0 mmol/L.
18 secondary outcomes
Achieved dose in each of the components of the primary endpoint (mg)
Time frame: 90 days
Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications
Time frame: 90 days
Change in quality of life by EQ-5D index
Time frame: 90 days
Change in quality of life by EQ-5D VAS
Time frame: 90 days
Change in N-terminal pro-B-type natriuretic peptide (ng/L)
Time frame: 90 days
Change in echocardiographic measures of left ventricular structure
Time frame: 90 days
Change in body weight (kg)
Time frame: 90 days
Self-care
Time frame: 90 days
Patient satisfaction with digital follow-up
Time frame: 90 days
Number of heart failure readmissions
Time frame: 12 months and 24 months
Number of total readmissions
Time frame: 12 months and 24 months
Time out of hospital
Time frame: 12 months and 24 months
Number of deaths
Time frame: 12 months and 24 months
Cost
Time frame: 90 days, 12 months, 24 months
Change in HF-specific quality of life
Time frame: 90 days
Change in echocardiographic measure of cardiac diastolic function
Time frame: 90 days
Change in echocardiographic measure of cardiac systolic function
Time frame: 90 days
Stricter treatment-emergent adverse events
Time frame: 90 days
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 17 Jun 2026.
- Background: PubMed 36356631Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data
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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.
Henrik Schirmer, MD, PhD contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital follow-up and uptitration of medications at home after hospital discharge for heart failure and Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure in people with Heart Failure, run by University Hospital, Akershus at 11 sites in Norway.
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 6 inclusion and 14 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway. 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?
Contact Peder L Myhre, MD, PhD (+47 93025644, p.l.myhre@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline recommended medical treatment Score (0-9) (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT06576752, which also lists 1 linked publication.
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 17 Jun 2026.