Left Ventricular HypertrophyPhase 4NCT00974857
Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
A Phase 4 study testing BCM in people with Left Ventricular Hypertrophy, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Left Ventricular Hypertrophy
- What is being tested?
- BCM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Sep 2010
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18-year,
- Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
- Willingness to participate in the study with a written informed consent.
Who cannot join
- Presence of a cardiac stent, pacemaker or defibrillator ,
- Artificial joints, pin or amputation
- Permanent or temporary catheters (may affect BCM measurement),
- Being scheduled for living donor renal transplantation,
- Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
- Pregnancy or lactating,
- Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,
- Mental incompetence.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Division of Nephrology
Bornova, İzmir, 35100
About this study
Official title: Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients
This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities.
Read the detailed description
The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hypertensive medication, intra-dialytic complications, and left ventricular geometry and functions assessed by echocardiography. One hundred and seventy-six prevalent HD patients will be randomized into two arms: study group and control group.
In the study group, "overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH)at least once a month before a dialysis session in order to determine dry weight.
- If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure.
- If OH is negative value , and:
- Systolic blood pressure is < 100 mmHg with/or intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %); we will increase dry weight accordingly.
- Systolic blood pressure is normal (100-150 mmHg) without intradialytic hypotension episodes and clothing and erythrocytosis; we will not change dry weight.
- Systolic blood pressure normal (100-150 mmHg) with intradialytic hypotension episodes and/or clothing and/or erythrocytosis; we will increase dry weight.
- Systolic blood pressure> 150 mmHg we will perform a captopril test (CT) If the CT is positive we will use ACE inhibitors / ARBs as anti hypertensive drugs and dry weight will be increased if intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %) are also present
If the CT is negative we will repeat the BCM measurement and if it gives same results we will perform ABPM for confirmation.
We will not need to reach the dry weight immediately. If severe BP drop precludes reaching DW in one session, an isolated ultrafiltration or additional dialysis session will be added.
In the control group, BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
The planned duration of the study is 12 months. All patients will be seen in every month during the study. Additional visits will be scheduled if any symptoms and intolerance are suspected.
- Conditions
- Left Ventricular Hypertrophy
- Being tested
- BCM, control group
- Keywords
- Hemodialysis, Left Ventricular Hypertrophy, Body Composition Monitor
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMDevice
Also called Body Composition Monitor,Fresenius Medical Care,Deutschland
Overhydration (OH) in liters will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight at least once a month before a dialysis session.
control groupOther
BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month.
1. If OH is positive, dry weight will be reached by ultrafiltration without regard to the level of blood pressure.
2. If OH is negative and:
* Systolic blood pressure(SBP)< 100 mmHg with/or intradialytic hypotension episodes(IDHE) and/or clothing and/or erythrocytosis(htc>36%);dry weight will be increased.
* SBP normal(100-150 mmHg) w/o IDHE and clothing and erythrocytosis;dry weight will not be changed.
* SBP normal(100-150 mmHg) with IDHE and/or clothing and/or erythrocytosis;dry weight will be increased.
* SBP>150 mmHg captopril test(CT)will be done. If CT is positive, ACEI/ ARBs will be used and dry weight will be increased if IDHE and/or clothing and/or erythrocytosis(htc>36%) are present.
If CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation. Receives: Device: BCM |
| Control Group | Other | BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of left ventricular mass index (LVMI)
Measured: 1 year
Secondary outcomes (6)
Changes in post-dialysis body weight
Measured: 1 year
Achievement of normal blood pressure level without using anti-hypertensive medication
Measured: 1 year
Decrease in left atrial volume
Measured: 1 year
Hematocrit and related rHu-EPO doses
Measured: 1 year
Serum levels of albumin and Hs-CRP
Measured: 1 year
Plasma level of pro-BNP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Responsible party
- Principal investigator, Ercan OK, Ege University
- Investigators
- Ercan Ok, MD, Study director, Ege University Division of NephrologyGulay Asci, MD, Principal investigator, Ege University Division of NephrologyEnder Hur, MD, Principal investigator, Ege University Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974857
- Sponsor's protocol ID
- 09-4/13
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2009
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00974857
- Acronym / sponsor ID
- 09-4/13
- Conditions
- Left Ventricular Hypertrophy
- Keywords
- Hemodialysis, Left Ventricular Hypertrophy, Body Composition Monitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Sep 2009 (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.
This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities.
Detailed description
The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hypertensive medication, intra-dialytic complications, and left ventricular geometry and functions assessed by echocardiography. One hundred and seventy-six prevalent HD patients will be randomized into two arms: study group and control group.
In the study group, "overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH)at least once a month before a dialysis session in order to determine dry weight.
- If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure.
- If OH is negative value , and:
- Systolic blood pressure is < 100 mmHg with/or intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %); we will increase dry weight accordingly.
- Systolic blood pressure is normal (100-150 mmHg) without intradialytic hypotension episodes and clothing and erythrocytosis; we will not change dry weight.
- Systolic blood pressure normal (100-150 mmHg) with intradialytic hypotension episodes and/or clothing and/or erythrocytosis; we will increase dry weight.
- Systolic blood pressure> 150 mmHg we will perform a captopril test (CT) If the CT is positive we will use ACE inhibitors / ARBs as anti hypertensive drugs and dry weight will be increased if intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %) are also present
If the CT is negative we will repeat the BCM measurement and if it gives same results we will perform ABPM for confirmation.
We will not need to reach the dry weight immediately. If severe BP drop precludes reaching DW in one session, an isolated ultrafiltration or additional dialysis session will be added.
In the control group, BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
The planned duration of the study is 12 months. All patients will be seen in every month during the study. Additional visits will be scheduled if any symptoms and intolerance are suspected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: BCMPre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month. 1. If OH is positive, dry weight will be reached by ultrafiltration without regard to the level of blood pressure. 2. If OH is negative and: * Systolic blood pressure(SBP)< 100 mmHg with/or intradialytic hypotension episodes(IDHE) and/or clothing and/or erythrocytosis(htc>36%);dry weight will be increased. * SBP normal(100-150 mmHg) w/o IDHE and clothing and erythrocytosis;dry weight will not be changed. * SBP normal(100-150 mmHg) with IDHE and/or clothing and/or erythrocytosis;dry weight will be increased. * SBP>150 mmHg captopril test(CT)will be done. If CT is positive, ACEI/ ARBs will be used and dry weight will be increased if IDHE and/or clothing and/or erythrocytosis(htc>36%) are present. If CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation. |
| Control Group | Other | Other: control groupBCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18-year,
- Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
- Willingness to participate in the study with a written informed consent.
Key exclusion criteria (8 listed)
- Presence of a cardiac stent, pacemaker or defibrillator ,
- Artificial joints, pin or amputation
- Permanent or temporary catheters (may affect BCM measurement),
- Being scheduled for living donor renal transplantation,
- Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
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 |
|---|---|---|
| BCMAlso: Body Composition Monitor,Fresenius Medical Care,DeutschlandOverhydration (OH) in liters will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight at least once a month before a dialysis session. | Device | Study group |
| control groupBCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be. | Other | Control Group |
Primary outcome
Regression of left ventricular mass index (LVMI)
Time frame: 1 year
6 secondary outcomes
Changes in post-dialysis body weight
Time frame: 1 year
Achievement of normal blood pressure level without using anti-hypertensive medication
Time frame: 1 year
Decrease in left atrial volume
Time frame: 1 year
Hematocrit and related rHu-EPO doses
Time frame: 1 year
Serum levels of albumin and Hs-CRP
Time frame: 1 year
Plasma level of pro-BNP
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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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.
Ercan Ok, MD study director
Ege University Division of Nephrology
Gulay Asci, MD principal investigator
Ege University Division of Nephrology
Ender Hur, MD principal investigator
Ege University Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BCM in people with Left Ventricular Hypertrophy, run by Ege University at 1 site in Turkey (Türkiye).
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 8 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: finished, as of the sponsor's last update on 9 Sep 2013. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of left ventricular mass index (LVMI) (time frame: 1 year). 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 9 Sep 2013.