Heart Failure
Conditions
Keywords
heart failure, digital health, remote monitoring
Brief 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.
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.
Interventions
OTHERDigital follow-up and uptitration of medications at home 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.
OTHERFollow-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.
Sponsors
University Hospital, Akershus
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
1. Age below 18 or above 85 years. 2. Clearly documented intolerance to high doses of beta-blockers 3. Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB). 4. Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis. 5. 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 6. 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. 7. Severe non-adherence to medications 8. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months. 9. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device. 10. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. 11. 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. 12. Low digital competency classified as inability to handle a smartphone or tablet. 13. Language barriers requiring the need for an external interpreter. 14. Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Guideline recommended medical treatment Score (0-9) | 90 days | 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 |
| Treatment-emergent adverse events | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achieved dose in each of the components of the primary endpoint (mg) | 90 days | Renin-angiotensin-system blockers, mineralocorticoid receptor antagonists and beta blockers, and treatment with sodium-glucose cotransporter-2-inhibitors |
| Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications | 90 days | 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% |
| Change in quality of life by EQ-5D index | 90 days | Measured by EuroQol Group (EQ-5D) index questionnaire (range 11111 to 55555, higher is worse) |
| Change in quality of life by EQ-5D VAS | 90 days | Measured by EuroQol Group (EQ-5D) questionnaire (range 0 to 100, lower is worse) |
| Change in N-terminal pro-B-type natriuretic peptide (ng/L) | 90 days | From baseline |
| Change in echocardiographic measures of left ventricular structure | 90 days | Left ventricular end diastolic volume index (ml/m\^2) |
| Change in body weight (kg) | 90 days | From baseline |
| Self-care | 90 days | European Heart Failure Self-care Behaviour \[EHFScB\] scale (range 9-45, higher is worse) |
| Patient satisfaction with digital follow-up | 90 days | IT-HEART questionnaire (range 10-50, higher is worse) |
| Number of heart failure readmissions | 12 months and 24 months | Admissions to the hospital for heart failure |
| Number of total readmissions | 12 months and 24 months | All admissions to the hospital |
| Time out of hospital | 12 months and 24 months | Days not admitted to a hospital after baseline |
| Number of deaths | 12 months and 24 months | All-cause mortality |
| Cost | 90 days, 12 months, 24 months | To evaluate the total cost of each follow up strategy by summarizing the cost of healthcare utilization, digital platform costs and travel costs |
| Change in HF-specific quality of life | 90 days | Minnesota Living with HF questionnaire (range 0-105, higher is worse) |
| Change in echocardiographic measure of cardiac diastolic function | 90 days | E/e' (ratio) |
| Change in echocardiographic measure of cardiac systolic function | 90 days | Left ventricular ejection fraction (%) |
| Stricter treatment-emergent adverse events | 90 days | 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 |
Countries
Norway
Contacts
CONTACTPeder L Myhre, MD, PhD
CONTACTHenrik Schirmer, MD, PhD
Outcome results
None listed