Management of Patients With Heart Failure at Home After Hospital Discharge
NCT Number: NCT06576752
Acronym: STRONG@HOME
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: Digital follow-up and uptitration of medications at home after hospital discharge for heart failure|OTHER: Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
Sponsor: University Hospital, Akershus
Collaborators: Drammen sykehus|Oslo University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2028-04-01

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. 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.

Primary Outcome Measures: Proportion of patients with ≥50% dose of guideline recommended heart failure medications, Proportion of patients with ≥50% dose of renin-angiotensin-system blockers, mineralocorticoid receptor antagonists and beta blockers, and treatment with sodium-glucose cotransporter-2-inhibitors, 90 days|Treatment-emergent adverse events, Proportion of patients with symptomatic hypotension, worsening renal function (doubling of creatinine), hyperkalemia (potassium \>6.0 mml/L), bradycardia \<50 beats/min, 90 days
Secondary Outcome Measures: 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, 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