A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Обзор

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

Вмешательства

• Препарат VS-041
  VS-041 high dose, VS-041 low dose or Placebo tablet BID
• Другое Placebo
  Placebo to match VS-041

Первичные конечные точки

• Participant incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: From Baseline to Day 28]
• Change from baseline over time in serum NordicPRO-C6 [Срок оценки: From Baseline to Day 28]
• Change from baseline over time in serum endotrophin [Срок оценки: From Baseline to Day 28]
• Change from baseline over time in serum NT-proBNP [Срок оценки: From Baseline to Day 28]

Вторичные конечные точки (2)

• Pharmacokinetic profiles and parameters derived for VS-041 - Tmax [Срок оценки: From Baseline to Day 28]
• Pharmacokinetic profiles and parameters derived for VS-041 - Cmax [Срок оценки: From Baseline to Day 28]

Критерии участия

Критерии включения

Participants must meet all inclusion criteria to be eligible for trial participation.

• Males or females ≥ 50 years of age at the time of signing the informed consent.
• Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
• NYHA Functional Class II or III
• LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure
• Elevated NT-proBNP at Screening
• NordicPRO-C6™ ≥ 11 ng/mL at Screening.
• Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
• Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to < 45 kg/m2.
• Males must agree to the contraception requirements and females must be of non-childbearing potential
• Able to understand and willing to sign a written informed consent form (ICF).
• Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.

Критерии исключения

• Female trial participant who is pregnant or breastfeeding.
• Known hypersensitivity to VS-041.
• Cardiovascular disease other than HFpEF
• Active intercurrent illness such as acute bacterial or viral infection.
• History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
• Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening.
• Acute decompensated HF within 30 days of Screening
• Lung disease within 12 months prior to Screening
• History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
• History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.
• Have participated within the last 6 months in a clinical study involving an investigational product.
• Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 21 центр

• Cardiology and Medicine Clinic — Little Rock
• National Institute of Clinical Research — Huntington Beach
• FOMAT — Santa Maria
• Invivocure LLC — Van Nuys
• New Generation of Medical Research — Hialeah
• Jacksonville Center for Clinical Research — Jacksonville
• Amavita Health — North Miami Beach
• Broward Research Center — Pembroke Pines
• … и ещё 13 центров

Идентификаторы

NCT: NCT07219511 · VS-041-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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