Exploration of the benefits and safety of the nutritional supplement Kardioli® versus placebo on the functional capacity of patients with stable chronic heart failure, with functional class II or III and reduced LVEF”. Phase II. - Kardioli®-heart failure-Phase II.

Catalysis Laboratories, SL.0 个研究点开始时间: 2023年3月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1-Patients with stable chronic heart failure with functional class II or III (NYHA) and reduced left ventricular ejection fraction (rFEVI) with a reference value =40%.
•2-Patients =19 years old.
•3-Patients receiving the standard treatment available for heart failure.
•4-Patients with a life expectancy = 3 months.
•5-Patients who signed the informed consent for the investigation

•1-Patients with end-stage of oncoploliferative processes.
•2-Patients who are being treated with another product under investigation.
•3-Patients with known hypersensitivity to any component of the product under investigation
•4-Patients with acute allergic states or a history of severe allergic reactions.
•5-Patients with acute, chronic, or decompensated inflammatory infectious diseases.
•6-Patients with psychiatric disorders that make it difficult to collect information, carry out treatment or follow-up
•7-Breastfeeding or postpartum patients, or those patients of childbearing age who refuse to use adequate contraceptive methods such as intrauterine devices, barrier methods or tubal ligation, hormonal contraceptives; and in the case of the male sex (vasectomy, use of condoms)

发起方

Catalysis Laboratories, SL.