Digital Solutions in Heart Therapy (DIGNITY)

Официальное название

Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое usual care
  Patients in the "usual care group" will be followed up according to the local practice until the end of the study.
• Другое 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.

Первичные конечные точки

• composite guideline-directed medical therapy optimization score [Срок оценки: 3 month post-discharge]

Вторичные конечные точки (9)

• Proportion of clinical encounters setting 1 [Срок оценки: during whole study phase from randomization to 90 days post-discharge]
• Proportion of clinical encounters setting 2 [Срок оценки: during whole study phase from randomization to 90 days post-discharge]
• Dosage of diuretics [Срок оценки: during whole study phase from randomization to 90 days post-discharge]
• Proportion of safety issues [Срок оценки: during whole study phase from randomization to 90 days post-discharge]
• Proportion of heart failure [Срок оценки: during whole study phase from randomization to 90 days post-discharge]
• Proportion of hospitalization [Срок оценки: during whole study phase from randomization to 90 days post-discharge]
• Quality of life score [Срок оценки: at randomization and 90 days post-discharge]
• Optimization score [Срок оценки: at randomization and 90 days post-discharge]
• Patient Health Questionnaire [Срок оценки: at randomization and 90 days post-discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT06942221 · 2024-02601; am24Zhou2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗