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New treatment option for Heart Failure With Reduced Ejection Fraction
Official title Digital Solutions in Heart Therapy (DIGNITY)
ClinicalTrials.gov ID: NCT06942221
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Hospitalized due to acute HF decompensation.
You likely can't join if
- 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...
- Cardiac resynchronization therapy device implantation within 3 months prior to screening
- Presence of significant obstructive lesion of the left ventricular outflow tract
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.