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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02696005
• Other study ID #: 109-15-BNZ
• Status: Not yet recruiting
• Phase: N/A
• First received: December 30, 2015
• Last updated: February 25, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2016
• Source: Bnai Zion Medical Center
• Contact: Eugeny Radzishevsky, MD
• Phone: 9724835394
• Email: eradzish[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Klotho hormone level	Change in serum Klotho level between "Baseline", "3 months" and "6 months" visits	"Baseline", "3 months" and "6 months"	No
Secondary	Incidence of Hospital Readmissions in patients with different serum level of KLOTHO		"3 months" and "6 months" and "1 Year"	No