Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
guideline-directed medical therapy, telemedicine
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.
Interventions
OTHERusual care
Patients in the usual care group will be followed up according to the local practice until the end of the study.
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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite guideline-directed medical therapy optimization score | 3 month post-discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of clinical encounters setting 2 | during whole study phase from randomization to 90 days post-discharge | 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 |
| Dosage of diuretics | during whole study phase from randomization to 90 days post-discharge | Requirement for decreasing or increasing dose of diuretics |
| Proportion of safety issues | during whole study phase from randomization to 90 days post-discharge | Safety outcomes including incidence of hypotension, hyperkalemia, acute kidney failure (doubling of baseline serum creatinine) |
| Proportion of heart failure | during whole study phase from randomization to 90 days post-discharge | Re-hospitalization due to heart failure decompensation |
| Proportion of clinical encounters setting 1 | during whole study phase from randomization to 90 days post-discharge | Proportion of clinical encounters with GDMT initiations when these therapies were not used at discharge |
| Quality of life score | at randomization and 90 days post-discharge | Quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ). |
| Optimization score | at randomization and 90 days post-discharge | Optimization score is defined as the sum of care optimization changes and care deoptimization changes. |
| Patient Health Questionnaire | at randomization and 90 days post-discharge | The Patient Health Questionnaire (PHQ-2) measures the frequency of depressed mood, with a score ranging from 0 to 6. |
| Proportion of hospitalization | during whole study phase from randomization to 90 days post-discharge | All-cause re-hospitalization |
Countries
Switzerland
Contacts
Primary ContactQian Zhou, Prof. MD
Outcome results
None listed