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Идёт набор NCT06593314

Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes

Без фазы С лечением Heart Failure Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Message with EchoGo, Standard Message.
Кому может быть актуально
Состояния в реестре: Heart Failure, Diabetes. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm

Обзор

A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.

Подробное описание

Historic echocardiograms will be analyzed using the Ultromics EchoGo algorithm. For patients that have a positive EchoGO result i.e. HFpEF detected, the provider will get an clinical decision support alert flagging high risk of HFpEF based on randomized assignment.

Experimental: Alert Group Provider will receive a computer-based provider-to-provider message notifying the provider that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors, non-steroidal MRA, or GLP-1 RA (if obesity is present). The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided. The investigators will assess the practice patterns of providers in response to the EHR-based alert over the study period (3, and 6-month follow-up). The investigators will also assess the downstream hospitalization events for HF within 12 months of the initial alert.

Control arm: Standard Message Providers in the control group will receive a standard message that will recommend either SGLT2i, GLP-1RA, and/or ns-MRA for treatment of diabetes and for prevention of heart failure. This group will not receive any information about the presence of subclinical heart failure detected by the EchoGo algorithm. The investigators will monitor the practice pattern in this group as well over the study period.

Follow Up. Adherence to SGLT-2i and GLP-1 RA medications will be assessed by evaluating the electronic health record and documenting if the patient had a follow-up with a healthcare provider at 3 and 6 months and medication listed in the active prescription medication list.

Sample Size: The investigators plan to enroll 800 anticipated patients using a parallel design with 1:1 allocation and a binary primary endpoint (SGLT2i use). Using a two-sample test for difference in proportions with the normal (Fleiss) approximation, pooled variance without continuity correction, and assuming a control proportion of 30%, α=0.05 (two-sided), and 80% power, an N=800 (400/arm) provides a minimum detectable absolute increase of \~9.4 percentage points (30.0% to 39.4% in the intervention arm). This corresponds to RR = 1.31(95% CI 1.08, 1.59) and Cohen's h = 0.20.

Вмешательства

  • Поведенческое Message with EchoGo
    This alert will inform the provider that the patient has subclinical HFpEF
  • Поведенческое Standard Message
    This alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure.

Первичные конечные точки

  • Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up [Срок оценки: 3-month follow-up]
  • Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 6 months follow-up [Срок оценки: 3-month follow-up]
Вторичные конечные точки (3)
  • Frequency of prescription of ns-MRA at outpatient clinic visits [Срок оценки: 6-months]
  • Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over [Срок оценки: 6 months follow-up]
  • Heart Failure hospitalization [Срок оценки: 12 months]

Критерии участия

Clinical cohort inclusion exclusion criteria:

Критерии включения

  • Patients with diagnosis of Type 2 diabetes and High WATCH DM score.
  • Echocardiogram available in last 6-months.

Критерии исключения

  • History of HF
  • Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA

Corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.

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
Профилактика

Центры проведения

США · 1 центр
  • UT Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT06593314 · STU-2024-0209

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗