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

NCT ID: NCT02696005

Last Updated: 2016-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I

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

Exercise- Based Cardiac Rehabilitation Programme

Intervention Type OTHER

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

Group II

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

Exercise- Based Cardiac Rehabilitation Programme

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise- Based Cardiac Rehabilitation Programme

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rehabilitation Programme

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eugeny Radzishevsky, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center- Ministry of Health, Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eugeny Radzishevsky, MD

Role: CONTACT

9724835394

Ehud Goldhammer, Prof

Role: CONTACT

9724835394

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

109-15-BNZ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.