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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

KARDIOLI

Scientific title:

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.

Acronym of Scientific Title:

Kardioli®-heart failure-Phase II.

Secondary indentifying numbers:

CAT-2022-3

Issuing authority of the secondary identifying numbers:

National Coordinating Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Catalysis Laboratories, SL

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Institute of Nutrition and Hygiene of food(INHA)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ana

Midle name:

Margarita

Last name:

Jerez Castro

Medical Specialty :

2nd Degree Specialist in Internal Medicine and Cardiology

Affiliation:

Institute of Cardiology and Cardiovascular Surgery (ICCCV)

Postal address:

17th street, No. 702, between A and Paseo, Vedado.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-77360824

Email address:

anamarjerez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

28/03/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic heart failure

Health condition(s) code:

Heart Failure

Heart Diseases

Cardiovascular Diseases

Intervention(s):

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 solution, every 12 hours for 12 months, plus the indicated treatment for Heart Failure

Intervention code:

Dietary Supplements

Administration, Oral

Placebos

Intervention keyword:

Kardioli

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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)

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

100 patients

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Pedro

Middle Name:

Pablo

Last Name:

Guerra Chaviano

Specialty:

MSc in Clinical Trials

Affiliation:

National Coordinating Clinical Trials Center (CENCEC)

Postal Address:

5ta A e/ 60 y 62 Miramar

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164124

Email :

pedrop@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ana

Middle Name:

Margarita

Last Name:

Jerez Castro

Specialty:

2nd Degree Specialist in Internal Medicine and Cardiology

Affiliation:

Institute of Cardiology and Cardiovascular Surgery (ICCCV)

Postal Address:

17th Street. No. 702 between A and Paseo, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-77360824

Email :

anamarjerez@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Cardiology and Cardiovascular Surgery (ICCCV)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

31/01/2022

Postal address of Ethic Committee :

17 street #702 between A and Paseo, Vedado, Havana. Cuba. ZC 10400

Telephone:

+5377360824

Email:

anamarjerez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

26/07/2024

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000417

Date of Registration in Primary Registry:

03/03/2023

Record Verification Date:

2023/03/03

Next update date:

2024/03/03

Link to the spanish version:

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

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