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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital follow-up and uptitration of medications at home after hospital discharge for heart failure | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days |
| Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications |
| Measure | Description | Time Frame |
|---|---|---|
| CardioSignal congestion index | Performance of the CardioSignal congestion index in detecting worsening HF: HF hospitalizations, increasing NT-proBNP and clinical congestion | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peder L Myhre, MD, PhD | Contact | +47 93025644 | p.l.myhre@medisin.uio.no | |
| Henrik Schirmer, MD, PhD | Contact | henrik.schirmer@medisin.uio.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Recruiting | Lørenskog | Akershus | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36356631 | Background | 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. |
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The investigators do not plan to share individual participant data
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| Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure | Other | 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. |
|
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% |
| 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) | 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) | 90 days |
| Change in N-terminal pro-B-type natriuretic peptide (ng/L) | From baseline | 90 days |
| Change in echocardiographic measures of left ventricular structure | Left ventricular end diastolic volume index (ml/m^2) | 90 days |
| Change in body weight (kg) | From baseline | 90 days |
| Self-care | European Heart Failure Self-care Behaviour [EHFScB] scale (range 9-45, higher is worse) | 90 days |
| Patient satisfaction with digital follow-up | IT-HEART questionnaire (range 10-50, higher is worse) | 90 days |
| Number of heart failure readmissions | Admissions to the hospital for heart failure | 12 months and 24 months |
| Number of total readmissions | All admissions to the hospital | 12 months and 24 months |
| Time out of hospital | Days not admitted to a hospital after baseline | 12 months and 24 months |
| Number of deaths | All-cause mortality | 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 | 90 days, 12 months, 24 months |
| Change in HF-specific quality of life | Minnesota Living with HF questionnaire (range 0-105, higher is worse) | 90 days |
| Change in echocardiographic measure of cardiac diastolic function | E/e' (ratio) | 90 days |
| Change in echocardiographic measure of cardiac systolic function | Left ventricular ejection fraction (%) | 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 | 90 days |
| Drammen Hospital, Vestre Viken HF | Recruiting | Drammen | Vestre Viken | 1878 | Norway |
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| Sørlandet Sykehus | Recruiting | Arendal | Norway |
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| Ålesund Hospital | Recruiting | Ålesund | Norway |
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| Innlandet sykehus | Recruiting | Hamar | Norway |
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| Levanger Sykehus | Recruiting | Levanger | Norway |
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| Østfold Hospital | Recruiting | Moss | Norway |
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| Oslo University Hospital | Recruiting | Oslo | Norway |
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| Stavanger University Hospital | Recruiting | Stavanger | Norway |
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| Tromsø University Hospital | Recruiting | Tromsø | Norway |
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| Tønsberg Sykehus | Recruiting | Tønsberg | Norway |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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