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NCT01421771 · ClinicalTrials.gov registry record · NA
Blood Pressure in Dialysis Patients
A NA study, sponsored by University of New Mexico.
- Completed
- Registry status
- NA
- Development phase
- 126
- Enrollment target
NCT01421771 is a NA study that has completed, run by University of New Mexico. The registered enrollment target is 126 participants.
The verdict
NCT01421771, a NA study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
Study Summary
Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (\<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.
Interventions
- DRUG Antihypertensive Agents
- OTHER Dry weight Challenge
- DIETARY_SUPPLEMENT Extend dialysis treatment time and re-challenge estimated dry weight
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01421771
The ClinicalTrials.gov registry entry for NCT01421771 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of New Mexico, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Antihypertensive Agents is the first listed.
NCT01421771 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01421771 about?
NCT01421771 is a clinical study titled "Blood Pressure in Dialysis Patients". Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients ha...
What is the current status of trial NCT01421771?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2011-10. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01421771?
The interventions under investigation include: Antihypertensive Agents (DRUG), Dry weight Challenge (OTHER), Extend dialysis treatment time and re-challenge estimated dry weight (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01421771?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
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