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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.
Show all 14Show fewer
  • 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.

Peder L Myhre, MD, PhD contact

+47 93025644

p.l.myhre@medisin.uio.no

Henrik Schirmer, MD, PhD contact

henrik.schirmer@medisin.uio.no

11 sites in 1 country

Norway11 sites, 11 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

    Recruiting

Other trials in Norway

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 groups in NCT06576752
Study groupRoleWhat they receive
Home careExperimentalFollow-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 careActive comparatorFollow-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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. Change in N-terminal pro-B-type natriuretic peptide (ng/L)

    From baseline

    Measured: 90 days

  6. Change in echocardiographic measures of left ventricular structure

    Left ventricular end diastolic volume index (ml/m^2)

    Measured: 90 days

  7. Change in body weight (kg)

    From baseline

    Measured: 90 days

  8. Self-care

    European Heart Failure Self-care Behaviour [EHFScB] scale (range 9-45, higher is worse)

    Measured: 90 days

  9. Patient satisfaction with digital follow-up

    IT-HEART questionnaire (range 10-50, higher is worse)

    Measured: 90 days

  10. Number of heart failure readmissions

    Admissions to the hospital for heart failure

    Measured: 12 months and 24 months

  11. Number of total readmissions

    All admissions to the hospital

    Measured: 12 months and 24 months

  12. Time out of hospital

    Days not admitted to a hospital after baseline

    Measured: 12 months and 24 months

  13. Number of deaths

    All-cause mortality

    Measured: 12 months and 24 months

  14. 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

  15. Change in HF-specific quality of life

    Minnesota Living with HF questionnaire (range 0-105, higher is worse)

    Measured: 90 days

  16. Change in echocardiographic measure of cardiac diastolic function

    E/e' (ratio)

    Measured: 90 days

  17. Change in echocardiographic measure of cardiac systolic function

    Left ventricular ejection fraction (%)

    Measured: 90 days

  18. 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.

  1. First posted29 Aug 2024
  2. Study start1 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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)
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

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; AzTrials last refreshed its copy on 8 Nov 2026.

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