An interventional study of Procedure: Regional phenylephrine arterial infusion in Chronic Kidney Disease and Hypertension, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by University of Michigan · Not applicable, Interventional, and Other
The purpose of this study is to learn more about why most patients with early stages of kidney disease have high blood pressure.
We know the body produces natural substances that cause blood vessels to open wider to carry more blood when needed. An example is during exercise. Other natural substances cause blood vessels to get smaller and slow down blood flow when needed. An example is when people are cold. The balance between these substances is important. People with kidney disease and high blood pressure do not have the normal balance of these substances.
This study will include 3 groups of people, people with normal blood pressure, people with high blood pressure and people with kidney disease.
The study will then compare the responses of the three groups. A GFR test will be done to confirm the renal function of the group with chronic kidney disease.
These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1 vasoreactivity in subjects with progressive renal disease. This will lay the groundwork for new strategies in the treatment and prevention of vascular disease among the rapidly growing group of individuals with CKD.
Enhanced adrenergic vascular reactivity may significantly contribute to hypertension and the excessive cardiovascular disease burden in patients with chronic kidney disease (CKD). Nitric oxide (NO), a modulator of neurovascular function, may be linked to adrenergic vascular responsiveness. The central HYPOTHESIS is that the reduction in endothelial nitric oxide (NO) bioavailability contributes to the enhancement of α1-adrenoceptor vasomotor function in patients with CKD.
Specific Aims: In patients with mild to moderate CKD, compared to matched hypertensive and normotensive controls without CKD:
Methods: CKD will be confirmed by I125-iothalamate glomerular filtration rate. Regional α1-adrenoceptor vasoreactivity (sensitivity [EC50], reactivity [slope]) will be assessed by venous plethsymography using a graded intra-arterial infusion of the α1-adrenoceptor agonist, phenylephrine. Comparisons of vasoreactivity at baseline and during infusions of L-NMMA will be made between hypertensive non-diabetic subjects with glomerular filtrations rates between 30-70 ml/min age-, gender-, ethnicity- and % body fat-matched hypertensive and normotensive subjects with normal kidney function. In addition, plasma levels of the endogenous NO inhibitor, asymmetric dimethylarginine will be measured in the hypertensive subjects with and without CKD and compared to vasoreactivity.
Significance. These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1 vasoreactivity in subjects with progressive renal disease.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 18 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
There are three groups of volunteers.
Exclusion Criteria:
People with:
Drug: Procedure: Regional phenylephrine arterial infusion
Drug: Procedure: Regional phenylephrine arterial infusion
Drug: Procedure: Regional phenylephrine arterial infusion
α1-adrenoceptor Vasoreactivity With L-NMMA
Vasoreactivity is defined as Forearm blood flow, dose response curve; ml per minute per log of phenylephrine, or FABF ml/min/logPE; The x axis is the ml/min value and the y axis is the log Phenylephrine concentration.
Time frame: up to 8 hours
α1-adrenoceptor Vasoreactivity With Endogenous ADMA
Time frame: up to 8 hours
Three screen failures
| Milestone | Chronic Kidney Disease (CKD) | Hypertension Group | Normotensive Group |
|---|---|---|---|
| Started | 7 | 2 | 6 |
| Completed | 7 | 2 | 5 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
Vasoreactivity is defined as Forearm blood flow, dose response curve; ml per minute per log of phenylephrine, or FABF ml/min/logPE; The x axis is the ml/min value and the y axis is the log Phenylephrine concentration.
| ml/min x 1/log[PE] | Chronic Kidney Disease | Normotensive Group |
|---|---|---|
| before L-NMMA infusion | -0.48 ± 0.10 | -0.22 ± 0.08 |
| after L-NMMA infusion | -0.31 ± 0.09 | -0.16 ± 0.11 |
No measurements were reported for this outcome.
Collected over Participants were interviewed for safety follow up approximately 7 - 10 days after procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic Kidney Disease | — | 0/7 (0%) | 0/7 (0%) |
| Hypertension Group | — | 0/2 (0%) | 0/2 (0%) |
| Normotensive Group | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Chronic Kidney Disease | Hypertension Group | Normotensive Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 2 | 6 | 15 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Chronic Kidney Disease | Hypertension Group | Normotensive Group | Total |
|---|---|---|---|---|
| Female | 2 | 1 | 4 | 7 |
| Male | 5 | 1 | 2 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Chronic Kidney Disease | Hypertension Group | Normotensive Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 6 | 2 | 6 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Chronic Kidney Disease | Hypertension Group | Normotensive Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 7 | 2 | 5 | 14 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Chronic Kidney Disease | Hypertension Group | Normotensive Group | Total |
|---|---|---|---|---|
| United States | 7 | 2 | 6 | 15 |
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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