Digital Solutions in Heart Therapy (DIGNITY)

Heart failure (HF) is a chronic condition affecting approximately 26 million people worldwide, with acute decompensations leading to frequent hospitalizations and increased mortality. While guideline-directed medical therapy (GDMT) has been shown to improve outcomes in HF with reduced ejection fraction (HFrEF), real-world data indicate suboptimal implementation, with delayed initiation and low adherence to target doses. The STRONG-HF study demonstrated that rapid up-titration of GDMT following hospitalization significantly reduces HF-related mortality and readmission, highlighting the importance of early and structured treatment optimization. However, close monitoring during the vulnerable post-discharge phase remains resource-intensive and difficult to implement in routine care.

The DIGNITY study aims to assess the safety and effectiveness of a telemedicine-guided strategy for optimizing GDMT in patients with HFrEF compared to usual care in Switzerland after discharge. The study hypothesizes that telemedicine-supported management will improve GDMT optimization and clinical outcomes in this high-risk patient population.

Inclusion criteria

• Age > 18 years at the time of hospital admission
• Ability to use a (smart)phone and/or tablet for the follow-up
• Documented left ventricular ejection fraction (LVEF) > 40% assessed within preceding 12 months
• Not treated with optimal doses of oral HF therapies within 2 days before anticipated hospital discharge for acute HF in at least one of the medication categories (for details see Table 1 on page 10)
• Hospitalized due to acute HF decompensation.
• Specific measures within 24 hours prior to randomization

• Systolic blood pressure > 100 mmHg, and heart rate > 60bpm
• Serum potassium < 5mmol/L

Exclusion criteria

• Inability to use a (smart)phone or tablet
• Clear intolerance to high doses of betablockers, ACE inhibitors, or ARBs
• Estimated glomerular filtration rate <30ml/min/1.73m2 or dialysis
• Myocardial infarction, unstable angina or cardiac surgery within 3 months, percutaneous transluminal coronary intervention within 1 months prior to screening
• Cardiac resynchronization therapy device implantation within 3 months prior to screening
• Presence of significant obstructive lesion of the left ventricular outflow tract
• Amyloid cardiomyopathy
• Participation in other clinical trials for drugs
• Pregnant or nursing women
• Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception