Heart FailureNCT02696005
Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
An observational study of Heart Failure, run by Bnai Zion Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise- Based Cardiac Rehabilitation Programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients suffering from Heart Failure and beginning Rehabilitation Programme
Who may be able to join
- Both genders
- Patients ≥ than 18 years
- Ejection Fraction ≤ than 40 %
Who cannot join
- Myocardial Infarction ≤ than 1.5 month before inclusion
- Renal failure with Creatinine ≥ 1.5 mg/dl
- Known Inflammatory condition.
- Patient taking Calcium Supplement,Vitamin D or pyrophosphate.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Exercise- Based Cardiac Rehabilitation Programme
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise- Based Cardiac Rehabilitation ProgrammeOther
Also called Rehabilitation Programme
Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.
| Study group | Role | What they receive |
|---|---|---|
| Group I | 15 patients who will continue participation in Exercise- Based Cardiac Rehabilitation Programme after completion initial 3-months period. Receives: Other: Exercise- Based Cardiac Rehabilitation Programme | |
| Group II | 15 patients who will stop participation in Exercise- Based Cardiac Rehabilitation Programme after the initial 3-months period. Receives: Other: Exercise- Based Cardiac Rehabilitation Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Klotho hormone level
Change in serum Klotho level between "Baseline", "3 months" and "6 months" visits
Measured: "Baseline", "3 months" and "6 months"
Secondary outcomes (1)
Incidence of Hospital Readmissions in patients with different serum level of KLOTHO
Measured: "3 months" and "6 months" and "1 Year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eugeny Radzishevsky, MD, Principal investigator, Bnai Zion Medical Center- Ministry of Health, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696005
- Sponsor's protocol ID
- 109-15-BNZ
- Status last verified
- Feb 2016
- First submitted
- 30 Dec 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme
- ClinicalTrials.gov ID
- NCT02696005
- Acronym / sponsor ID
- 109-15-BNZ
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: Exercise- Based Cardiac Rehabilitation Programme15 patients who will continue participation in Exercise- Based Cardiac Rehabilitation Programme after completion initial 3-months period. |
| Group II | – | Other: Exercise- Based Cardiac Rehabilitation Programme15 patients who will stop participation in Exercise- Based Cardiac Rehabilitation Programme after the initial 3-months period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients suffering from Heart Failure and beginning Rehabilitation Programme
Key inclusion criteria (3 listed)
- Both genders
- Patients ≥ than 18 years
- Ejection Fraction ≤ than 40 %
Key exclusion criteria (4 listed)
- Myocardial Infarction ≤ than 1.5 month before inclusion
- Renal failure with Creatinine ≥ 1.5 mg/dl
- Known Inflammatory condition.
- Patient taking Calcium Supplement,Vitamin D or pyrophosphate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise- Based Cardiac Rehabilitation ProgrammeAlso: Rehabilitation ProgrammeExercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure. | Other | Group I, Group II |
Primary outcome
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
1 secondary outcome
Incidence of Hospital Readmissions in patients with different serum level of KLOTHO
Time frame: "3 months" and "6 months" and "1 Year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugeny Radzishevsky, MD principal investigator
Bnai Zion Medical Center- Ministry of Health, Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Bnai Zion Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugeny Radzishevsky, MD (9724835394, eradzish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Klotho hormone level (time frame: "Baseline", "3 months" and "6 months"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.