RecruitingNot ApplicableNCT06942221

Digital Solutions in Heart Therapy (DIGNITY)

Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment


Sponsor

University Hospital, Basel, Switzerland

Enrollment

140 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria10

  • 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

Interventions

OTHERguideline-directed medical therapy

Patients are followed via an App, data will be evaluated by the Telemedicine team, and participants will be contacted via phone 1 week after discharge and subsequently every 7-10 days to discuss the up-titration of the HF medications.

OTHERusual care

Patients in the "usual care group" will be followed up according to the local practice until the end of the study.


Locations(1)

University Hospital Basel

Basel, Switzerland

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NCT06942221


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