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

Sponsor
Bnai Zion Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02696005
Collaborator
(none)
30
Enrollment
12
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise- Based Cardiac Rehabilitation Programme

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Group I

15 patients who will continue participation in Exercise- Based Cardiac Rehabilitation Programme after completion initial 3-months period.

Other: Exercise- Based Cardiac Rehabilitation Programme
Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.
Other Names:
  • Rehabilitation Programme

    		•
    Group II

    15 patients who will stop participation in Exercise- Based Cardiac Rehabilitation Programme after the initial 3-months period.

    Other: Exercise- Based Cardiac Rehabilitation Programme
    Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.
    Other Names:
  • Rehabilitation Programme

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum Klotho hormone level ["Baseline", "3 months" and "6 months"]

      Change in serum Klotho level between "Baseline", "3 months" and "6 months" visits

    Secondary Outcome Measures

    1. Incidence of Hospital Readmissions in patients with different serum level of KLOTHO ["3 months" and "6 months" and "1 Year"]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bnai Zion Medical Center

    Investigators

    • Principal Investigator: Eugeny Radzishevsky, MD, Bnai Zion Medical Center- Ministry of Health, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bnai Zion Medical Center
    ClinicalTrials.gov Identifier:
    NCT02696005
    Other Study ID Numbers:
    • 109-15-BNZ
    First Posted:
    Mar 2, 2016
    Last Update Posted:
    Mar 2, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Mar 2, 2016