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

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000417

Enrollment

Unknown

Registered

2023-03-03

Start date

2023-03-28

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Experimental group: nutritional supplement 1 vial (30 ml), oral solution, every 12 hours for 12 months, plus the indicated treatment for Heart Failure Control group: placebo, 1 vial (30 ml), oral solu

Dietary Supplements

Administration, Oral

Placebos

Kardioli

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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. Left ventricular ejection fraction (LVEF): Echocardiogram. Measurement time: initial evaluation (To), month 6, and month 12.	—

Secondary

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

Countries

Cuba

Contacts

Public ContactPedro Guerra Chaviano

National Coordinating Clinical Trials Center (CENCEC)

pedrop@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026