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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11099284

Enrollment

200

Registered

2025-01-12

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Heart failure with reduced left ventricular ejection fraction Circulatory System

Interventions

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 foll

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 r

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome(s) as of 21/05/2026: 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 a polymerase chain reaction and after digestion of the amplified DNA sequence with a restriction enzyme at one time point Exercise tolerance will be assessed using the following methods: 1. 6-minute walk test (6MWT)- the distance covered by the subject in meters in six minutes before and after 3 weeks of cardiac rehabilitation combined with pharmacotherapy. 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), systolic blood pressure (RRs) and diastolic blood pressure (RRr) at rest and peak exercise. The test will be performed before and after the completion of 3 weeks of cardiac rehabilitation combined with pharmacotherapy. Left ventricular systolic and diastolic function will be assessed by echocardiography (UKG) using the following indices before and after a 3-week cardiac rehabilitation combined with drug treatment: 1. Left ventricular end-diastolic diameter (LVEDD)- in mm 2. Left ventricular end-systolic diameter (LVESD)- in mm 3. Left ventricular end-systolic volume (LVESV)- in ml 4. Left ventricular ejection fraction (LVEF)- in % Quality of life will be assessed using the following measures before and 3 and 12-16 weeks after the completion of cardiac rehabilitation combined with pharmacotherapy: 1. Minnesota Living with Heart Failure Questionnaire (LHFQ) 2. Questionnaire SF-36 v.2 3. Beck Depression Scale Physical activity will be measured using the following questionnaires before and 12-16 weeks a	—

Measure

Time frame

Current primary outcome(s) as of 21/05/2026: 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 a polymerase chain reaction and after digestion of the amplified DNA sequence with a restriction enzyme at one time point Exercise tolerance will be assessed using the following methods: 1. 6-minute walk test (6MWT)- the distance covered by the subject in meters in six minutes before and after 3 weeks of cardiac rehabilitation combined with pharmacotherapy. 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), systolic blood pressure (RRs) and diastolic blood pressure (RRr) at rest and peak exercise. The test will be performed before and after the completion of 3 weeks of cardiac rehabilitation combined with pharmacotherapy. Left ventricular systolic and diastolic function will be assessed by echocardiography (UKG) using the following indices before and after a 3-week cardiac rehabilitation combined with drug treatment: 1. Left ventricular end-diastolic diameter (LVEDD)- in mm 2. Left ventricular end-systolic diameter (LVESD)- in mm 3. Left ventricular end-systolic volume (LVESV)- in ml 4. Left ventricular ejection fraction (LVEF)- in % Quality of life will be assessed using the following measures before and 3 and 12-16 weeks after the completion of cardiac rehabilitation combined with pharmacotherapy: 1. Minnesota Living with Heart Failure Questionnaire (LHFQ) 2. Questionnaire SF-36 v.2 3. Beck Depression Scale Physical activity will be measured using the following questionnaires before and 12-16 weeks a

—

Secondary

Measure	Time frame
1. NTproBNP [pg/ml], TNFa [ng/ml], and CRP [mg/ml] blood levels before and after 3-week cardiac rehabilitation combined with pharmacotherapy 2. Medication review measured using patient medical records before and 12-16 weeks after cardiac rehabilitation	—

Countries

Poland

Contacts

Public ContactEwa Kucio

e.kucio@awf.katowice.pl+48 (0)664 421 164

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026