Kardioli® nutritional supplement versus placebo in patients with chronic heart failure. Phase II.

Phase 2

• Conditions: Chronic heart failure; Heart Failure; Heart Diseases; Cardiovascular Diseases

• Registration Number: RPCEC00000417
• Lead Sponsor: Catalysis Laboratories, SL.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Last Update Posted: 19 August 2024
• Study Completion: 2024-10-26
• Results First Posted: 2025-06-26

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional capacity: Ergospirometry, Class I, II, III or IV Classification according to NYHA. Measurement time: initial evaluation (To) (only class II and III), month 6, and month 12.<br>Left ventricular ejection fraction (LVEF): Echocardiogram. Measurement time: initial evaluation (To), month 6, and month 12.<br><br><br>

Secondary Outcome Measures

Name	Time	Method
1-Nutritional status: calculation of the Body Mass Index (BMI). Measurement time: To, month 3, month 6 and month 12.<br>2-Quality of life (QOL): Kansas City Questionnaire (KCCQ-23). Measurement time: To, month 6 and month 12.<br>3-Humoral response: biomarkers of myocardial damage (NT Pro BNP, C-reactive protein and troponin T). Measurement time: To, month 6 and month 12.<br><br>