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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| usual care group | Active Comparator | usual care according to local practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| usual care | Other | Patients in the "usual care group" will be followed up according to the local practice until the end of the study. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Zhou, Prof. MD | Contact | +41 3286828 | qian.zhou@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Qian Zhou, Prof. MD | Universitätsspital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| 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. |
|
|
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 |