Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme

Study Overview
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Brief Summary
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30 patients suffering from Heart Failure with Ejection Fraction less than 40% start Cardiac Rehabilitation Programme, serum KLOTHO Hormone level and other labs and Echo measurements will be taken on the first visit. After completion of 3-month Rehabilitation Programme the second set of labs and Echo measurements will be taken. Than participants will be divided for 2 groups: the patients who wish to continue Rehabilitation programme for additional 3-month period and the second group that prefer to stop Rehabilitation programme after completion of the first 3 month period. For both groups additional set of labs will be taken this time and at the end of the study. The Aim of the study: to investigate association between serum KLOTHO level, physical activity and possible correlation with laboratory and echocardiographic parameters in cohort of Heart Failure patients.

Detailed Description
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30 patients, age range older than 18 years old suffering from Heart Failure, Functional capacity II-III and echocardiographic evidence of Left Ventricular Ejection Fraction less than 40% beginning Cardiac Rehabilitation Programme. Following recruitment of patients to the study each one will undergo serum KLOTHO Hormone level assessment along with kidney functions, N terminal -Pro B-Type Natriuretic Peptide hormone activity and Echo measurements . After completion of 3-months Exercise based Rehabilitation Programme set at 70-80% of maximal individual exercise capacity,a second identical set of lab tests and Echo measurements will be performed. After than participants will be divided into 2 groups: Group I will comprise patients who wish to continue Rehabilitation programme for additional 3-months period and the Group II those who will stop Exercise Rehabilitation programme following completion of the first 3 months. Both groups will undergo additional set of lab tests at this six-months-point. Except for the primary and secondary end-points all possible correlations between serum KLOTHO level and age, sex, Ejection Fraction, functional capacity, N terminal -Pro B-Type Natriuretic Peptide hormone activity hormone level and kidney function indices will be evaluated.

Official Title
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Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Exercise- Based Cardiac Rehabilitation Programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders Patients ≥ than 18 years Ejection Fraction ≤ than 40 % Exclusion Criteria: Myocardial Infarction ≤ than 1.5 month before inclusion Renal failure with Creatinine ≥ 1.5 mg/dl Known Inflammatory condition. Patient taking Calcium Supplement,Vitamin D or pyrophosphate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>15 patients who will continue participation in Exercise- Based Cardiac Rehabilitation Programme after completion initial 3-months period. | Other: Exercise- Based Cardiac Rehabilitation Programme<br>* Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.<br>* Other names: Rehabilitation Programme;|
| Group II<br>15 patients who will stop participation in Exercise- Based Cardiac Rehabilitation Programme after the initial 3-months period. | Other: Exercise- Based Cardiac Rehabilitation Programme<br>* Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.<br>* Other names: Rehabilitation Programme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Klotho hormone level | Change in serum Klotho level between Baseline, 3 months and 6 months visits | Baseline, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hospital Readmissions in patients with different serum level of KLOTHO |  | 3 months and 6 months and 1 Year |