Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure

Обзор

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily. The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.

Вмешательства

• Препарат empagliflozin
  intake of a 10mg empagliflozin oral tablet At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.
• Препарат Placebo tablet
  intake a placebo oral tablet At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.

Первичные конечные точки

• change in LA function [Срок оценки: 9 months]

Вторичные конечные точки (12)

• change in left ventricular ejection fraction [Срок оценки: 9 months]
• change in global longitudinal strain [Срок оценки: 9 months]
• change in mass (indexed to body surface area) [Срок оценки: 9 months]
• change in E/e' ratio [Срок оценки: 9 months]
• change in plasma protein levels: DLK-1 (protein delta homolog 1) [Срок оценки: 9 months]
• change in plasma protein levels: GDF15 (growth differentiating factor 15) [Срок оценки: 9 months]
• change in plasma protein levels: Spondin-1 [Срок оценки: 9 months]
• change in plasma protein levels: IGBPF-7 [Срок оценки: 9 months]
• change in plasma protein levels: THBS-2 (thrombospondin 2) [Срок оценки: 9 months]
• change in plasma protein levels: IGFBP-1 (insulin-like binding factor protein 1) [Срок оценки: 9 months]
• change in plasma protein levels: FABP-4 (fatty acid-binding protein 4) [Срок оценки: 9 months]
• change in plasma protein levels: CCL16 (C-C motif chemokine 16) [Срок оценки: 9 months]

Критерии участия

Критерии включения

• Age >60 years of age
• Clinical diagnosis of hypertension
• Body mass index ≥30kg/m2
• We will screen for participants with an echocardiogram within 60 days of the baseline visit

Критерии исключения

• Female participants who are pregnant, lactating, or of child bearing potential
• History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c >7.0% at Visit 1
• Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record
• Any LVEF measure of ≤40% on past echocardiogram
• Moderate or severe valve disease on echocardiogram
• History of genitourinary infection
• eGFR <60 ml/min/1.73 m2 at Visit 1
• Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors
• Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months
• Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations
• Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease
• Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
• Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit
• Inadequate quality echocardiographic images
• Unstable coronary syndromes
• Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1.
• Non-English speaking individuals

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06507657 · CV-2023-32230

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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