Managing heart failure patients at home after hospital discharge

Contemporary Post-Discharge Management in Heart Failure At Home

This study tests if heart failure patients can manage their health better at home with digital check-ins after leaving the hospital instead of going to regular doctor visits.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Hospital, Akershus (Academic / other)
• Locations: 2 sites (Lørenskog, Akershus and 1 other locations)
• Trial ID: NCT06576752 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether patients with acute heart failure can effectively manage their condition through digital follow-up at home instead of traditional hospital visits. Patients recently discharged from the hospital will be randomized to receive either digital follow-up or standard outpatient clinic follow-up. The goal is to demonstrate that home-based monitoring and medication adjustments can improve patient outcomes and reduce the burden on healthcare systems. This approach addresses barriers such as travel distance and mobility issues that many patients face when attending hospital appointments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 who have been hospitalized for acute heart failure and meet specific clinical criteria.

Not a fit: Patients with documented intolerance to high doses of heart failure medications or those with severe renal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of heart failure, leading to better patient outcomes and reduced hospital readmissions.

How similar studies have performed: While the STRONG-HF trial has shown success with in-clinic follow-ups, this home-based digital approach is novel and has not been previously tested in a clinical trial.

Eligibility criteria

Inclusion Criteria:

* 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 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.

Where this trial is running

Lørenskog, Akershus and 1 other locations

• Akershus University Hospital — Lørenskog, Akershus, Norway (Recruiting)
• Drammen Hospital, Vestre Viken HF — Drammen, Vestre Viken, Norway (Recruiting)

Study contacts

• Study coordinator: Peder L Myhre, MD, PhD

Conditions Heart Failure; heart failure; digital health; remote monitoring