Clinical trial NCT06576752: Management of Patients with Heart Failure At Home After Hospital Discharge
Official title: Contemporary Post-Discharge Management in Heart Failure At Home
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
digital health
remote monitoring
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Drammen sykehus
name: Oslo University Hospital
First posted: 2024-08-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Hospital admission within the 72 hours prior to screening for acute HF.
* NT-proBNP \&gt; 1,500 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.

Primary outcomes:
measure: Guideline recommended medical treatment Score (0-9)
timeFrame: 90 days
measure: Treatment-emergent adverse events
timeFrame: 90 days
Secondary outcomes:
measure: Achieved dose in each of the components of the primary endpoint (mg)
timeFrame: 90 days
measure: Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications
timeFrame: 90 days
measure: Change in quality of life by EQ-5D index
timeFrame: 90 days
measure: Change in quality of life by EQ-5D VAS
timeFrame: 90 days
measure: Change in N-terminal pro-B-type natriuretic peptide (ng/L)
timeFrame: 90 days
measure: Change in echocardiographic measures of left ventricular structure
timeFrame: 90 days
measure: Change in body weight (kg)
timeFrame: 90 days
measure: Self-care
timeFrame: 90 days
measure: Patient satisfaction with digital follow-up
timeFrame: 90 days
measure: Number of heart failure readmissions
timeFrame: 12 months and 24 months
measure: Number of total readmissions
timeFrame: 12 months and 24 months
measure: Time out of hospital
timeFrame: 12 months and 24 months
measure: Number of deaths
timeFrame: 12 months and 24 months
measure: Cost
timeFrame: 90 days, 12 months, 24 months
measure: Change in HF-specific quality of life
timeFrame: 90 days
measure: Change in echocardiographic measure of cardiac diastolic function
timeFrame: 90 days
measure: Change in echocardiographic measure of cardiac systolic function
timeFrame: 90 days
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Drammen
country: Norway
facility: Drammen Hospital, Vestre Viken HF
state: Vestre Viken
Study officials:
References:
citation: 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.