Digital Solutions in Heart Therapy (DIGNITY)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: usual care, guideline-directed medical therapy.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment
Overview
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
- Other usual care
Patients in the "usual care group" will be followed up according to the local practice until the end of the study. - 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.
Primary outcome measures
- composite guideline-directed medical therapy optimization score [Time frame: 3 month post-discharge]
Secondary outcome measures (9)
- Proportion of clinical encounters setting 1 [Time frame: during whole study phase from randomization to 90 days post-discharge]
- Proportion of clinical encounters setting 2 [Time frame: during whole study phase from randomization to 90 days post-discharge]
- Dosage of diuretics [Time frame: during whole study phase from randomization to 90 days post-discharge]
- Proportion of safety issues [Time frame: during whole study phase from randomization to 90 days post-discharge]
- Proportion of heart failure [Time frame: during whole study phase from randomization to 90 days post-discharge]
- Proportion of hospitalization [Time frame: during whole study phase from randomization to 90 days post-discharge]
- Quality of life score [Time frame: at randomization and 90 days post-discharge]
- Optimization score [Time frame: at randomization and 90 days post-discharge]
- Patient Health Questionnaire [Time frame: at randomization and 90 days post-discharge]
Eligibility criteria
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
- Systolic blood pressure > 100 mmHg, and heart rate > 60bpm
- Serum potassium < 5mmol/L
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT06942221 · 2024-02601; am24Zhou2