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Digital Solutions in Heart Therapy (DIGNITY)

ConditionHeart Failure With Reduced Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • usual care

    Other intervention

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

  • guideline-directed medical therapy

    Other intervention

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: telemedicine guided care groupExperimental treatment 1 intervention
Group B: usual care groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

composite guideline-directed medical therapy optimization score

composite guideline-directed medical therapy (GDMT) score is defined as the sum of care optimization changes and care deoptimization changes at 3 months post discharge.

Time frame
3 month post-discharge

Secondary outcomes

1

Proportion of clinical encounters setting 1

Proportion of clinical encounters with GDMT initiations when these therapies were not used at discharge

Time frame
during whole study phase from randomization to 90 days post-discharge
2

Proportion of clinical encounters setting 2

Proportion of clinical encounters with either GDMT initiations and/ or dose uptitrations, net GDMT intensification and changes in the prescription of individual GDMT elements from time to hospital admission to discharge

Time frame
during whole study phase from randomization to 90 days post-discharge
3

Dosage of diuretics

Requirement for decreasing or increasing dose of diuretics

Time frame
during whole study phase from randomization to 90 days post-discharge
4

Proportion of safety issues

Safety outcomes including incidence of hypotension, hyperkalemia, acute kidney failure (doubling of baseline serum creatinine)

Time frame
during whole study phase from randomization to 90 days post-discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov
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