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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02696005
Enrollment
30
Registered
2016-03-02
Start date
2016-03-31
Completion date
2017-03-31
Last updated
2016-03-02

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

Conditions

Heart Failure

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.

Interventions

OTHERExercise- Based Cardiac Rehabilitation Programme

Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum Klotho hormone levelBaseline, 3 months and 6 monthsChange in serum Klotho level between Baseline, 3 months and 6 months visits

Secondary

MeasureTime frame
Incidence of Hospital Readmissions in patients with different serum level of KLOTHO3 months and 6 months and 1 Year

Contacts

Primary ContactEugeny Radzishevsky, MD
eradzish@gmail.com9724835394
Backup ContactEhud Goldhammer, Prof
ehud.goldhammer@b-zion.org.il9724835394

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026