Digital Solutions in Heart Therapy (DIGNITY) (DIGNITY - HF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: guideline-directed medical therapy; Other: usual care

Detailed Description

Heart failure (HF) is a chronic condition affecting approximately 26 million people worldwide, with acute decompensations leading to frequent hospitalizations and increased mortality. While guideline-directed medical therapy (GDMT) has been shown to improve outcomes in HF with reduced ejection fraction (HFrEF), real-world data indicate suboptimal implementation, with delayed initiation and low adherence to target doses. The STRONG-HF study demonstrated that rapid up-titration of GDMT following hospitalization significantly reduces HF-related mortality and readmission, highlighting the importance of early and structured treatment optimization. However, close monitoring during the vulnerable post-discharge phase remains resource-intensive and difficult to implement in routine care.

The DIGNITY study aims to assess the safety and effectiveness of a telemedicine-guided strategy for optimizing GDMT in patients with HFrEF compared to usual care in Switzerland after discharge. The study hypothesizes that telemedicine-supported management will improve GDMT optimization and clinical outcomes in this high-risk patient population.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Zhou, Prof. MD; Phone Number: +41 3286828; Email: qian.zhou@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Qian Zhou, Prof. MD.; Phone Number: +41 3286828; Email: qian.zhou@usb.ch
    • Principal Investigator: Qian Zhou, Prof. MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telemedicine guided care group; 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; 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.; Other Names: telemedicine
Active Comparator: usual care group; usual care according to local practice	Other: usual care; Patients in the "usual care group" will be followed up according to the local practice until the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of clinical encounters setting 1	Proportion of clinical encounters with GDMT initiations when these therapies were not used at discharge	during whole study phase from randomization to 90 days post-discharge
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	during whole study phase from randomization to 90 days post-discharge
Dosage of diuretics	Requirement for decreasing or increasing dose of diuretics	during whole study phase from randomization to 90 days post-discharge
Proportion of safety issues	Safety outcomes including incidence of hypotension, hyperkalemia, acute kidney failure (doubling of baseline serum creatinine)	during whole study phase from randomization to 90 days post-discharge
Proportion of heart failure	Re-hospitalization due to heart failure decompensation	during whole study phase from randomization to 90 days post-discharge
Proportion of hospitalization	All-cause re-hospitalization	during whole study phase from randomization to 90 days post-discharge
Quality of life score	Quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ).	at randomization and 90 days post-discharge
Optimization score	Optimization score is defined as the sum of care optimization changes and care deoptimization changes.	at randomization and 90 days post-discharge
Patient Health Questionnaire	The Patient Health Questionnaire (PHQ-2) measures the frequency of depressed mood, with a score ranging from 0 to 6.	at randomization and 90 days post-discharge

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Qian Zhou, Prof. MD, Universitätsspital Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: telemedicine; guideline-directed medical therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: 2024-02601; am24Zhou2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No