Digital Solutions in Heart Therapy (DIGNITY)

NCT ID: NCT06942221

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-17
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

guideline-directed medical therapy

Intervention Type: 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.

usual care group

usual care according to local practice

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

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

Interventions

usual care

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

telemedicine

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. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qian Zhou, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel

Locations

University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Qian Zhou, Prof. MD

Role: CONTACT

qian.zhou@usb.ch

+41 3286828

Facility Contacts

Qian Zhou, Prof. MD.

Role: primary

qian.zhou@usb.ch

+41 3286828

Other Identifiers

2024-02601; am24Zhou2

Identifier Type: -

Identifier Source: org_study_id