Status:
RECRUITING
Management of Patients with Heart Failure At Home After Hospital Discharge
Lead Sponsor:
University Hospital, Akershus
Collaborating Sponsors:
Drammen sykehus
Oslo University Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
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-...
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 ...
Eligibility Criteria
Inclusion
- Hospital admission within the 72 hours prior to screening for acute HF.
- NT-proBNP \> 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06576752
Start Date
October 1 2024
End Date
April 1 2028
Last Update
March 25 2025
Active Locations (2)
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1
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
2
Drammen Hospital, Vestre Viken HF
Drammen, Vestre Viken, Norway, 1878