Status:
RECRUITING
Digital Solutions in Heart Therapy (DIGNITY)
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
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 comparis...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06942221
Start Date
July 17 2025
End Date
December 31 2026
Last Update
December 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Basel
Basel, Switzerland, 4031