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Search / Trial NCT06942221

Digital Solutions in Heart Therapy (DIGNITY)

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Apr 16, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Guideline Directed Medical Therapy Telemedicine

ClinConnect Summary

The DIGNITY trial is studying how a telemedicine approach can help manage heart failure in patients who are hospitalized. Heart failure is a condition where the heart doesn't pump blood as well as it should, and this trial will compare the effectiveness of using digital tools to guide treatment against standard care methods in Switzerland. The goal is to see if this digital strategy can improve patient outcomes by ensuring that they receive the best medical therapies for their condition.

To be eligible for this trial, participants must be over 18 years old and able to use a smartphone or tablet. They should have a specific type of heart failure, known as reduced ejection fraction, and need to be hospitalized due to worsening heart failure symptoms. Importantly, they should not have been treated with the best doses of heart failure medications just before leaving the hospital. Those who join the study will receive support through telemedicine to help optimize their treatment after discharge. This trial is not yet recruiting participants, but it aims to provide valuable insights into how technology can enhance heart failure care.

Gender

ALL

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

About University Hospital, Basel, Switzerland

The University Hospital Basel, Switzerland, is a leading academic medical center renowned for its commitment to cutting-edge research and innovative patient care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise and state-of-the-art facilities to advance medical knowledge and therapeutic options across various disciplines. With a collaborative approach that integrates clinical practice and scientific inquiry, the University Hospital Basel fosters an environment conducive to rigorous clinical trials, ensuring the highest standards of safety and efficacy. Its strategic focus on patient-centered research aims to translate scientific discoveries into tangible health solutions, benefiting both local and global communities.

Locations

Basel, , Switzerland

Patients applied

0 patients applied

Trial Officials

Qian Zhou, Prof. MD

Principal Investigator

Universitätsspital Basel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported