An interventional study of 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 Heart Failure, sponsored by University Hospital, Akershus. Recruiting at 11 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Health services research
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 450 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 28 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Digital follow-up and uptitration of medications at home after hospital discharge for heart failure
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)
Other: Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
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.
Also known as: 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.
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
Time frame: 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.
Time frame: 90 days
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
Time frame: 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%
Time frame: 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)
Time frame: 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)
Time frame: 90 days
Change in N-terminal pro-B-type natriuretic peptide (ng/L)
From baseline
Time frame: 90 days
Change in echocardiographic measures of left ventricular structure
Left ventricular end diastolic volume index (ml/m\^2)
Time frame: 90 days
Change in body weight (kg)
From baseline
Time frame: 90 days
Self-care
European Heart Failure Self-care Behaviour \[EHFScB\] scale (range 9-45, higher is worse)
Time frame: 90 days
Patient satisfaction with digital follow-up
IT-HEART questionnaire (range 10-50, higher is worse)
Time frame: 90 days
Number of heart failure readmissions
Admissions to the hospital for heart failure
Time frame: 12 months and 24 months
Number of total readmissions
All admissions to the hospital
Time frame: 12 months and 24 months
Time out of hospital
Days not admitted to a hospital after baseline
Time frame: 12 months and 24 months
Number of deaths
All-cause mortality
Time frame: 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
Time frame: 90 days, 12 months, 24 months
Change in HF-specific quality of life
Minnesota Living with HF questionnaire (range 0-105, higher is worse)
Time frame: 90 days
Change in echocardiographic measure of cardiac diastolic function
E/e' (ratio)
Time frame: 90 days
Change in echocardiographic measure of cardiac systolic function
Left ventricular ejection fraction (%)
Time frame: 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
Time frame: 90 days
CardioSignal congestion index
Performance of the CardioSignal congestion index in detecting worsening HF: HF hospitalizations, increasing NT-proBNP and clinical congestion
Time frame: 90 days
Plan to share: No — The investigators do not plan to share individual participant data
Started Oct 2024 (actual). Primary completion is estimated for Dec 2027, 38 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 38 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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