End-stage Renal DiseaseNCT02238093
Cardiorenal Syndrome in End-Stage Kidney Disease
An observational study of End-stage Renal Disease and Cardiorenal Syndrome, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients. Recently, its prevalence is rising. There are several different clinical presentations of this syndrome. It has a high rate of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, Cardiorenal Syndrome, Heart Disease
- How many people
- 270 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Feb 2015
- 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: End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.
Who may be able to join
- End-stage renal patients
Who cannot join
- Cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients. Recently, its prevalence is rising. There are several different clinical presentations of this syndrome. It has a high rate of morbidity and mortality.
The purpose of this study is to find the connection between the heart pathology and its effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these patients, and hopefully, aid in increasing their quality of life, and decrease their morbidity and mortality.
- Conditions
- End-stage Renal Disease, Cardiorenal Syndrome, Heart Disease
- Medical subject headings
- Kidney Failure, Chronic, Cardio-Renal Syndrome, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis Patients | End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Pathology Identification
Visual identification of heart pathology in ESRD patients using echocardiography by measuring the ejection fraction of the left-ventricle during the systolic and diastolic phases. Valvular pathology is measured by the size of the valve.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Noa Berar-Yanay, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238093
- Sponsor's protocol ID
- 106-13-HYMC
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorenal Syndrome in End-Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT02238093
- Acronym / sponsor ID
- 106-13-HYMC
- Conditions
- End-stage Renal Disease, Cardiorenal Syndrome, Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 12 Sep 2014 (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.
Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients. Recently, its prevalence is rising. There are several different clinical presentations of this syndrome. It has a high rate of morbidity and mortality.
The purpose of this study is to find the connection between the heart pathology and its effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these patients, and hopefully, aid in increasing their quality of life, and decrease their morbidity and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis Patients | – | –End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.
Key inclusion criteria (1 listed)
- End-stage renal patients
Key exclusion criteria (1 listed)
- Cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Pathology Identification
Time frame: One hour
Visual identification of heart pathology in ESRD patients using echocardiography by measuring the ejection fraction of the left-ventricle during the systolic and diastolic phases. Valvular pathology is measured by the size of the valve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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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.
Noa Berar-Yanay, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease and Cardiorenal Syndrome, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Noa Berar-Yanay, MD (972-4-630-4115, noab@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Pathology Identification (time frame: One hour). 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 12 Sep 2014.