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

February 25, 2016 updated by: Bnai Zion Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

30 patients suffering from Heart Failure and beginning Rehabilitation Programme

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109-15-BNZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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