Phase 4
Completed N=55
Mechanisms and Treatment of Intradialytic Hypertension
Intradialytic Hypertension
Source: ClinicalTrials.gov NCT00827775 ↗
Enrolled (actual)
55
Serious AEs
10.0%
Results posted
Nov 2020
Primary outcomePrimary: Endothelial Progenitor Cells — 0.052; 0.034; 0.027; 0.059 % of mononuclear cells
◆ Published Evidence
Established
78citations · ~5 / year
Intradialytic hypertension and the association with interdialytic ambulatory blood pressure.
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 mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
2. 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.
Linked Publications (3)
-
Intradialytic hypertension and the association with interdialytic ambulatory blood pressure.
-
Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction.
-
Intradialytic hypertension and its association with endothelial cell dysfunction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Progenitor Cells |
0.052; 0.034; 0.027; 0.059; 0.033; 0.029 | — |
| SECONDARY Flow Mediated Vasodilation |
1.67; 1.03; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00827775) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.