NCT06942221 Digital Solutions in Heart Therapy (DIGNITY)
| NCT ID | NCT06942221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-07-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. Participation in other clinical trials for drugs 9. Pregnant or nursing women 10. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception
Contact & Investigator
Qian Zhou, Prof. MD
PRINCIPAL INVESTIGATOR
Universitätsspital Basel
Frequently Asked Questions
Who can join the NCT06942221 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06942221 currently recruiting?
Yes, NCT06942221 is actively recruiting participants. Contact the research team at qian.zhou@usb.ch for enrollment information.
Where is the NCT06942221 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06942221 clinical trial?
NCT06942221 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Qian Zhou, Prof. MD at Universitätsspital Basel. The trial plans to enroll 140 participants.
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