Digital Solutions in Heart Therapy (DIGNITY)
Recruiting · NCT06942221 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
guideline-directed medical therapyusual care
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital Basel - Basel, Switzerland