Heart Failure With Reduced Ejection FractionDIGNITY - HFNCT06942221
Digital Solutions in Heart Therapy (DIGNITY)
A study testing guideline-directed medical therapy in people with Heart Failure With Reduced Ejection Fraction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- guideline-directed medical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Qian Zhou, Prof. MD., +41 3286828, qian.zhou@usb.ch
Qian Zhou, Prof. MD.
About this study
Official title: 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.
Read the 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.
- Being tested
- usual care, guideline-directed medical therapy
- Keywords
- guideline-directed medical therapy, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
Patients in the "usual care group" will be followed up according to the local practice until the end of the study.
guideline-directed medical therapyOther
Also called telemedicine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: guideline-directed medical therapy |
| usual care group | Active comparator | usual care according to local practice Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month post-discharge
Secondary outcomes (9)
Proportion of clinical encounters setting 1
Proportion of clinical encounters with GDMT initiations when these therapies were not used at discharge
Measured: 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
Measured: during whole study phase from randomization to 90 days post-discharge
Dosage of diuretics
Requirement for decreasing or increasing dose of diuretics
Measured: 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)
Measured: during whole study phase from randomization to 90 days post-discharge
Proportion of heart failure
Re-hospitalization due to heart failure decompensation
Measured: during whole study phase from randomization to 90 days post-discharge
Proportion of hospitalization
All-cause re-hospitalization
Measured: during whole study phase from randomization to 90 days post-discharge
Quality of life score
Quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ).
Measured: at randomization and 90 days post-discharge
Optimization score
Optimization score is defined as the sum of care optimization changes and care deoptimization changes.
Measured: 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.
Measured: at randomization and 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start17 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Zhou, Prof. MD, Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942221
- Sponsor's protocol ID
- 2024-02601; am24Zhou2
- Acronym
- DIGNITY - HF
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment
- ClinicalTrials.gov ID
- NCT06942221
- Acronym / sponsor ID
- DIGNITY - HF / 2024-02601; am24Zhou2
- Keywords
- guideline-directed medical therapy, telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine guided care group | Experimental | Other: guideline-directed medical therapyPatients 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 | Other: usual careusual care according to local practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual carePatients in the "usual care group" will be followed up according to the local practice until the end of the study. | Other | usual care group |
| guideline-directed medical therapyAlso: telemedicinePatients 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 | telemedicine guided care group |
Primary outcome
composite guideline-directed medical therapy optimization score
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qian Zhou, Prof. MD principal investigator
Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guideline-directed medical therapy in people with Heart Failure With Reduced Ejection Fraction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Zhou, Prof. MD (+41 3286828, qian.zhou@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite guideline-directed medical therapy optimization score (time frame: 3 month post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.