Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
1 other identifier
observational
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 2, 2016
February 1, 2016
1 year
December 30, 2015
February 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Klotho hormone level
Change in serum Klotho level between "Baseline", "3 months" and "6 months" visits
"Baseline", "3 months" and "6 months"
Secondary Outcomes (1)
Incidence of Hospital Readmissions in patients with different serum level of KLOTHO
"3 months" and "6 months" and "1 Year"
Study Arms (2)
Group I
15 patients who will continue participation in Exercise- Based Cardiac Rehabilitation Programme after completion initial 3-months period.
Group II
15 patients who will stop participation in Exercise- Based Cardiac Rehabilitation Programme after the initial 3-months period.
Interventions
Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.
Eligibility Criteria
30 patients suffering from Heart Failure and beginning Rehabilitation Programme
You may qualify if:
- Both genders
- Patients ≥ than 18 years
- Ejection Fraction ≤ than 40 %
You may not qualify if:
- Renal failure with Creatinine ≥ 1.5 mg/dl
- Known Inflammatory condition.
- Patient taking Calcium Supplement,Vitamin D or pyrophosphate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eugeny Radzishevsky, MD
Bnai Zion Medical Center- Ministry of Health, Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2015
First Posted
March 2, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 2, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share