Telemedicine-guided GDMT optimization for heart failure (DIGNITY)
Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment
NA · University Hospital, Basel, Switzerland · NCT06942221
This program will test whether telemedicine-guided care can help hospitalized patients with reduced ejection fraction get to guideline-recommended heart-failure medications and doses faster than usual care after discharge in Switzerland.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT06942221 on ClinicalTrials.gov |
What this trial studies
DIGNITY enrolls patients hospitalized for acute heart failure with reduced ejection fraction who are not yet on optimal guideline-directed medical therapy and follows them after discharge with either a telemedicine-guided management strategy or usual care. Participants must be able to use a smartphone or tablet and meet basic safety criteria before enrollment, including systolic blood pressure >100 mmHg and serum potassium <5 mmol/L. The telemedicine arm supports early, structured up-titration of heart-failure medications with remote monitoring of symptoms, vital signs, and laboratory safety. Medication optimization, clinical outcomes, and safety events will be compared between the telemedicine and usual-care groups at prespecified follow-up points.
Who should consider this trial
Good fit: Adults hospitalized for acute decompensated heart failure with reduced ejection fraction who can use a smartphone or tablet, are not already on optimal doses of guideline medications, and meet the study's safety thresholds are the intended participants.
Not a fit: Patients unable to use a smartphone or tablet, those with severe renal dysfunction (eGFR <30 ml/min/1.73 m2) or on dialysis, recent major cardiac events or surgery, or clear intolerance to core heart-failure drugs are unlikely to benefit from this telemedicine strategy.
Why it matters
Potential benefit: If successful, the approach could increase the proportion of patients on target doses of guideline heart-failure drugs and reduce readmissions and deaths after hospitalization.
How similar studies have performed: Prior work such as STRONG-HF showed that rapid post-discharge up-titration of guideline therapies reduces mortality and readmission, and smaller telemedicine interventions have shown promising but mixed results for medication optimization.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Qian Zhou, Prof. MD — Universitätsspital Basel
- Study coordinator: Qian Zhou, Prof. MD
- Email: qian.zhou@usb.ch
- Phone: +41 3286828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Reduced Ejection Fraction, guideline-directed medical therapy, telemedicine