Telemedicine-guided GDMT optimization for heart failure (DIGNITY)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HFrEF polypill strategy in Sri Lanka

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.