CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 126 enrolled
Drug / intervention
Antihypertensive Agents +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01421771
NCT01421771N/ACompleted

Blood Pressure in Dialysis Patients (BID Study)

University of New Mexico·interventional·Posted Aug 23, 2011·Updated Nov 30, 2023

In Brief

A clinical study evaluating Antihypertensive Agents, Dry weight Challenge, and 1 other intervention for Hypertension and 3 related conditions. Completed, enrolled 126 participants across 21 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.9 years ago

Interventions

Antihypertensive Agentsdrug

Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator

Dry weight Challengeother

Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal

Extend dialysis treatment time and re-challenge estimated dry weightdietary

Extend dialysis treatment time and re-challenge estimated dry weight