Digital Solutions in Heart Therapy (DIGNITY) (DIGNITY - HF)

University Hospital Basel

Status: Begins enrollment this month

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: guideline-directed medical therapy; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06942221

2024-02601 am24Zhou2;

Details and patient eligibility

About

This study aims to assess the safety and effectiveness of telemedicine guided strategy on guideline-directed medical therapy (GDMT) optimization in hospitalized patients with heart failure in comparison to usual care in Switzerland.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years at the time of hospital admission

2. Ability to use a (smart)phone and/or tablet for the follow-up

3. Documented left ventricular ejection fraction (LVEF) > 40% assessed within preceding 12 months

4. 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)

5. Hospitalized due to acute HF decompensation.

6. Specific measures within 24 hours prior to randomization

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

Exclusion criteria

1. Inability to use a (smart)phone or tablet
2. Clear intolerance to high doses of betablockers, ACE inhibitors, or ARBs
3. Estimated glomerular filtration rate <30ml/min/1.73m2 or dialysis
4. Myocardial infarction, unstable angina or cardiac surgery within 3 months, percutaneous transluminal coronary intervention within 1 months prior to screening
5. Cardiac resynchronization therapy device implantation within 3 months prior to screening
6. Presence of significant obstructive lesion of the left ventricular outflow tract
7. Amyloid cardiomyopathy
8. Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

telemedicine guided care group

Experimental group

Description:

Patients will be instructed to response to questions using the App daily. The parameters and questionnaires will be evaluated by the Telemedicine team, and participants will be contacted via phone 1 week after discharge and subsequently every 7-10 days to discuss the up-titration of the HF medications.

Treatment:

Other: guideline-directed medical therapy

usual care group

Active Comparator group

Description:

usual care according to local practice

Treatment:

Other: usual care