Intradialytic HypertensionPhase 4MATCHNCT00827775
Mechanisms and Treatment of Intradialytic Hypertension
A Phase 4 study testing Carvedilol in people with Intradialytic Hypertension, run by University of Texas Southwestern Medical Center at 3 sites in United States.
Trial summary
1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intradialytic Hypertension
- What is being tested?
- Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on hemodialysis > 30 days
- aged 18 to 80 years old
- ability to provide informed consent
- Primary nephrologist deems patient is at target dry weight
- Predialysis SBP >140 or postdialysis SBP>130
Who cannot join
- Patients with active wounds
- Blood pressure unable to be measured by routine mechanisms in the upper extremity
- Change in blood pressure medications in the previous 2 weeks
- Intolerance of beta or alpha-blockers
- pregnancy
- Resting heart rate <50
- Life expectancy < 6 months
- Current therapy with carvedilol or contraindication to carvedilol (ONLY in the intervention arm)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UTSW Oakcliff Davita Dialysis
Dallas, Texas, 75224
UTSW Dallas East Davita Dialysis (Buckner unit)
Dallas, Texas, 75228
UTS Dallas Dialysis (Elmbrook)
Dallas, Texas, 75247
About this study
Official title: Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
- To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
- To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.
- Conditions
- Intradialytic Hypertension
- Being tested
- Carvedilol
- Keywords
- Hypertension, Hemodialysis
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
| Intervention | Active comparator | Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Progenitor Cells
- ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
- CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
Measured: 12 weeks
Secondary outcomes (1)
Flow Mediated Vasodilation
Measured as percent change in brachial artery diameter from baseline to post shear stress for an individual measurement. Follow up measurements were obtained in intervention subjects 12 weeks later
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intradialytic HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Peter Van Buren, University of Texas Southwestern Medical Center
- Investigators
- Jula K Inrig, MD, MHS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827775
- Sponsor's protocol ID
- STU 102008-042
- Other IDs
- NIH K23 HL092297
- Acronym
- MATCH
- Status last verified
- Oct 2020
- First submitted
- 21 Jan 2009
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto R. Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction. Clin J Am Soc Nephrol. 2012 Aug;7(8):1300-9. doi: 10.2215/CJN.10010911. Epub 2012 Jun 14.
PubMed 22700888Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto RD. Intradialytic hypertension and its association with endothelial cell dysfunction. Clin J Am Soc Nephrol. 2011 Aug;6(8):2016-24. doi: 10.2215/CJN.11351210. Epub 2011 Jul 14.
PubMed 21757643Van Buren PN, Kim C, Toto R, Inrig JK. Intradialytic hypertension and the association with interdialytic ambulatory blood pressure. Clin J Am Soc Nephrol. 2011 Jul;6(7):1684-91. doi: 10.2215/CJN.11041210.
PubMed 21734087
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00827775
- Acronym / sponsor ID
- MATCH / STU 102008-042
- Conditions
- Intradialytic Hypertension
- Keywords
- Hypertension, Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
- To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
| Intervention | Active comparator | Drug: CarvedilolPatients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- on hemodialysis > 30 days
- aged 18 to 80 years old
- ability to provide informed consent
- Primary nephrologist deems patient is at target dry weight
- Predialysis SBP >140 or postdialysis SBP>130
Key exclusion criteria (8 listed)
- Patients with active wounds
- Blood pressure unable to be measured by routine mechanisms in the upper extremity
- Change in blood pressure medications in the previous 2 weeks
- Intolerance of beta or alpha-blockers
- pregnancy
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 |
|---|---|---|
| CarvedilolCarvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid | Drug | Intervention |
Primary outcome
Endothelial Progenitor Cells
Time frame: 12 weeks
1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry 2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
1 secondary outcome
Flow Mediated Vasodilation
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22700888Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto R. Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction. Clin J Am Soc Nephrol. 2012 Aug;7(8):1300-9. doi: 10.2215/CJN.10010911. Epub 2012 Jun 14.
- Results publication: PubMed 21757643Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto RD. Intradialytic hypertension and its association with endothelial cell dysfunction. Clin J Am Soc Nephrol. 2011 Aug;6(8):2016-24. doi: 10.2215/CJN.11351210. Epub 2011 Jul 14.
- Results publication: PubMed 21734087Van Buren PN, Kim C, Toto R, Inrig JK. Intradialytic hypertension and the association with interdialytic ambulatory blood pressure. Clin J Am Soc Nephrol. 2011 Jul;6(7):1684-91. doi: 10.2215/CJN.11041210.
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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.
Jula K Inrig, MD, MHS principal investigator
University of Texas Southwestern Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol in people with Intradialytic Hypertension, run by University of Texas Southwestern Medical Center at 3 sites in United States.
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 5 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endothelial Progenitor Cells (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827775, which also lists 3 linked publications.
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 3 Nov 2020.