Management of Patients With Heart Failure at Home After Hospital Discharge
Recruiting · NCT06576752 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Akershus
View the official record on ClinicalTrials.gov →Interventions studied
Digital follow-up and uptitration of medications at home after hospital discharge for heart failureFollow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- Age below 18 or above 85 years.
- Clearly documented intolerance to high doses of beta-blockers
- Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
- Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis.
- 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
- 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.
- Severe non-adherence to medications
- Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
- 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.
- Low digital competency classified as inability to handle a smartphone or tablet.
- Language barriers requiring the need for an external interpreter.
- Pregnant or nursing (lactating) women.
Where it is running
11 locations listed.
- Sørlandet Sykehus - Arendal, Norway
- Innlandet sykehus - Hamar, Norway
- Levanger Sykehus - Levanger, Norway
- Østfold Hospital - Moss, Norway
- Oslo University Hospital - Oslo, Norway
- Stavanger University Hospital - Stavanger, Norway
- Tromsø University Hospital - Tromsø, Norway
- Tønsberg Sykehus - Tønsberg, Norway
- Ålesund Hospital - Ålesund, Norway
- Akershus University Hospital - Lørenskog, Akershus, Norway
- Drammen Hospital, Vestre Viken HF - Drammen, Vestre Viken, Norway