Digital Solutions in Heart Therapy (DIGNITY)

NCT06942221 | Recruiting DMC

• 1 other identifier: 2024-02601; am24Zhou2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

guideline-directed medical therapy; telemedicine

Outcome Measures

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.

  3 month post-discharge

Secondary Outcomes (9)

• Proportion of clinical encounters setting 1

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

• Proportion of clinical encounters setting 2

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

• Dosage of diuretics

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

• Proportion of safety issues

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

• Proportion of heart failure

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

Study Arms (2)

telemedicine guided care group

EXPERIMENTAL

Patients will be instructed to response to questions using the App daily. The parameters and questionnaires 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.

Other: guideline-directed medical therapy

usual care group

ACTIVE COMPARATOR

usual care according to local practice

Other: usual care

Interventions

usual care OTHER

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

usual care group

guideline-directed medical therapy OTHER

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.

Also known as: telemedicine

telemedicine guided care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Qian Zhou, Prof. MD

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Zhou, Prof. MD

CONTACT

+41 3286828; qian.zhou@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: April 24, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

CH (1)