Patented # 3186 U1. International patents pending. All rights reserved.
Heart Failure (HF) is a clinical syndrome characterized by typical symptoms (shortness of breath, edema of the ankles, fatigue). HF could be accompanied with signs (increased jugular venous pressure, pulmonary crepitations and peripheral edema), caused by organic and/or functional disturbances of the heart leading to reduced cardiac output and/or increased intracardial pressures at rest or during stress. The basic terminology used in the description of HF is historical and is based upon the measurement of the left ventricular ejection fraction (LVEF). Heart failure is observed in a wide range of cases varying from patients with normal LVEF [as typical are accepted values ≥50%; HF with preserved LVEF (HFpEF)] to patients with reduced LVEF (HFrEF)]. Patients with LVEF ranging between 40-49% represent a “grey zone” – HF with a mid-range EF (HFmrEF).
CLINICAL TRIAL Prof. Dr Ivo Petrov, Dr Kamen Stoychev. Citi Clinic, Sofia, Bulgaria.
Our study has targeted patients with ischemic and patients with non-ischemic cardiomyopathy. As a consequence of the underlying cardiomyopathy, the patients we registered for our study exhibited HF with reduced EF or with mid-range EF.
To a huge degree the pumping function of the LV is predetermined by the quantity of the main “engine” of all energy dependent processes in the body – the ATP. ATP is the main source of energy for cellular processes. This is the molecule which preserves and provides the energy needed for our daily activities. It is found in the cytoplasm and in the nucleoplasm of our cells and is needed for all the energy requiring physiological processes.
Three different subunits are needed for its formation: an adenine nitrogenous base, a ribose and three phosphate groups. The ATP possesses two macroergic bonds, which upon their break-up, release energy needed by the body.
D-ribose is a natural sugar and is one of the three different units needed for the synthesis and maintenance of normal levels of ATP in the body. This makes ribose vital for the organism’s energy exchange. Through an additional intake of d-ribose it is expected to facilitate the production and consequently increase the levels of ATP in patients with HfREF.
Creatine: In the muscle creatine is at an equilibrium with its phosphorylated form – creatine phosphate. It gives away one phosphate group towards the synthesis of ATP. One third of creatine in muscle cells is free and two thirds are phosphorylated (phosphocreatine). Again, the additional intake of creatine facilitates the synthesis of ATP.
Co enzyme Q10 /Ubiquinone/ vitamin Q10: Co Q10 is a fat-soluble Vitamin, which is absorbed in the small intestines in the form of water-soluble micelles. A number of studies have proven its beneficial effects on patients with cardiovascular diseases thanks to: left ventricular hypertrophy; slowing down of the fibrotic changes in the heart; increase of the levels of NO and improvement of the electron transport in the body. As a consequence of the above benefits, intake of CoQ10 leads to improvement of the pumping function of the left ventricle, improvement of the endothelial function, decrease of the atherosclerotic and inflammatory changes and as a result: fewer re-hospitalizations, decrease of mortality rate, improvement of the quality of life.
The ratio we have chosen in one “00” size capsule is: 360 mg of creatine + 360 mg of d-ribose + 30 mg of ubiquinone and 2 mg of vitamin E. The daily intake should be anywhere in the range between three times one and 9 times one capsules per day, half an hour before meals, however we have achieved optimal therapeutic effect with three times six “00” size capsules per day. The four components are mixed in a powder form and are put in capsules size “00” (760 mg).
The severity of HF in the patients which we have selected for our study was represented with a moderately (40-49%) to severely (<40%) reduced pumping function of the left ventricle. For the time being we have included 34 patients, two of whom have been removed from the program. From all these 26 are men and 8 are women. The average age of our patients is 54.95 years and the mean LVEF at the beginning of the study was 27.76%. All of our patients took the combination of creatine, d-ribose, CoQ10 and vitamin E according to the above scheme (three times six capsules size”00” per day). With the control echocardiography conducted after the first month of taking the above combined product we measured a mean increase of the LVEF in our patients of 35.32%.
In the same time, 10 of our patients were taking Entresto, five patients underwent the implantation of a system for resynchronization therapy, 15 patients underwent percutaneous coronary intervention and four patients received coronary by-pass surgery. 13 of our patients were tested for NTproBNP, and will be tested again at the end of the study (after the 6th month). Our observations show increase of the pumping function of the left ventricle of 8-10% on the average (a relative 30% improvement) and an objective improvement of the quality of life based on answering the heart failure questioner (Kansas City), which was answered by our patients at the beginning of the study and at the end.
The selected products are nutrients and their intake does not replace the necessity for a drug therapy of the heart failure according to the European recommendations for treatment of heart failure. The combination and synergistic therapeutic action of the above nutrients are also appropriate for the treatment of chronic fatigue.
PATENTED 3186 U1. INTERNATIONAL PATENTS PENDING - INKMED Ltd. All rights reserved.