Effect of selected gene polymorphisms on the effectiveness of cardiac rehabilitation of patients with heart failure

Evaluation of the influence of selected gene polymorphisms on the effectiveness of cardiac rehabilitation in combination with pharmacotherapy in heart failure patients with reduced left ventricular ejection fraction

Registry ID
ISRCTN11099284
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Academy of Physical Education in Katowice
Enrollment
200
Start date
2025-06-01
Completion date
2026-09-30
Last update
2026-08-17

Conditions

Summary

Heart failure with reduced left ventricular ejection fraction

Detailed description

Current methodology as of 21/05/2026: After patients have qualified for the study and agreed to participate in the biomedical experiment, oral swab will be taken from each patient, in which the following will be analysed: DNA genomes which will be extracted from cheek epithelial cells. Polymorphism of genes [ACE (rs4340; I/D), TNF-a (rs1800629, -308G/A and rs1799964, -1031T/C), eNOS (rs1799983, 894G /T; rs2070744, -786T/C and tandem repeat polymorphism in exon 4: 4A/4B) and BNP (rs198389, -381T/C) will be detected by polymerase chain reaction and after digestion of the amplified DNA sequence with a restriction enzyme. Detection of gene polymorphism will be performed by the Silesia LabMed Research and Implementation Centre Medical Uniwersity of Silesia, Katowice, Poland Adiditionaly blood will be taken from ulner vein of each patient to determine NT-proBNP, TNFa, and CRP concentrations. In addition, each patient will be assessed for: 1. Exercise tolerance which will be assessed by means of: 1.1. 6-minute walk test (6MWT), 1.2. Submaximal (85% HRmax) treadmill exercise test according to the classic Bruce protocol. The following indices will be analysed during the test: test duration [min], distance covered [m], the MET energy expenditure, resting heart rate (HRS) and peak heart rate (85%HRmax), (85% HRmax), systolic systolic blood pressure (RRs) and diastolic blood pressure (RRr) at rest and at peak exercise. 2. Left ventricular systolic and diastolic function will be assessed by echocardiography (UKG). The following indices will be analysed: left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular end-systolic volume (LVESV), and left ventricular ejection fraction (LVEF). In addition, Tissue Doppler Imaging (TDI) indices will be assessed: A-wave (diastolic function mechanism during atrial contraction), E-wave (diastolic function mechanism during the rapid ventricular filling phase), elateral (early di

Interventions

Inclusion criteria

1. Documented heart failure (HFrEF) 2. Echocardiographically determined left ventricular ejection fraction (EF) <50% 3. NYHA class II-IV 4. Clinical stability and no change in treatment within the last month 5. Consent to participate in the study

Exclusion criteria

1. Unstable ischaemic heart disease 2. Hemodynamically significant aortic valve stenosis 3. Valvular heart diseases requiring surgical repair 4. Complex ventricular arrhythmias 5. Implantation of a cardiac stimulator, cardioverter defibrillator (ICD) and cardiac resynchronisation pacemaker (CRT-D) 6. Acute myocarditis or pericarditis 7. Uncontrolled hypertension 8. Acute thrombosis or embolism 9. Exacerbation of COPD 10. Hepatic or renal insufficiency 11. Lack of consent to participate in the study

Locations

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