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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
450
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.
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.
Akershus University Hospital
Lørenskog, Akershus, Norway
RECRUITINGDrammen Hospital, Vestre Viken HF
Drammen, Vestre Viken, Norway
RECRUITINGGuideline 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 \<50 bpm, and serum potassium of \>5.5 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
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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