Clinical trial NCT06942221: Digital Solutions in Heart Therapy (DIGNITY)
Official title: Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: guideline-directed medical therapy
telemedicine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: composite guideline-directed medical therapy optimization score
timeFrame: 3 month post-discharge
Secondary outcomes:
measure: Proportion of clinical encounters setting 1
timeFrame: during whole study phase from randomization to 90 days post-discharge
measure: Proportion of clinical encounters setting 2
timeFrame: during whole study phase from randomization to 90 days post-discharge
measure: Dosage of diuretics
timeFrame: during whole study phase from randomization to 90 days post-discharge
measure: Proportion of safety issues
timeFrame: during whole study phase from randomization to 90 days post-discharge
measure: Proportion of heart failure
timeFrame: during whole study phase from randomization to 90 days post-discharge
measure: Proportion of hospitalization
timeFrame: during whole study phase from randomization to 90 days post-discharge
measure: Quality of life score
timeFrame: at randomization and 90 days post-discharge
measure: Optimization score
timeFrame: at randomization and 90 days post-discharge
measure: Patient Health Questionnaire
timeFrame: at randomization and 90 days post-discharge
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Universitätsspital Basel
name: Qian Zhou, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: