Clinical trial NCT02696005: Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
Official title: Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients suffering from Heart Failure and beginning Rehabilitation Programme

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Both genders
2. Patients ≥ than 18 years
3. Ejection Fraction ≤ than 40 %

Exclusion Criteria:

1. Myocardial Infarction ≤ than 1.5 month before inclusion
2. Renal failure with Creatinine ≥ 1.5 mg/dl
3. Known Inflammatory condition.
4. Patient taking Calcium Supplement,Vitamin D or pyrophosphate.

Primary outcomes:
measure: Serum Klotho hormone level
timeFrame: "Baseline", "3 months" and "6 months"
Secondary outcomes:
measure: Incidence of Hospital Readmissions in patients with different serum level of KLOTHO
timeFrame: "3 months" and "6 months" and "1 Year"
Other outcomes:
Locations:
Study officials:
affiliation: Bnai Zion Medical Center- Ministry of Health, Israel
name: Eugeny Radzishevsky, MD
role: PRINCIPAL_INVESTIGATOR
References: