This study examines whether in hemodialysis patients with intradialytic hypertension (P) a single or weekly administration of irbesartan or nebivolol (I) compared to no drug administration (C) reduces peridialytic, intradialytic and ambulatory BP levels, as well as ambulatory arterial stiffness parameters (O).

Aristotle University of Thessaloniki School of Medicine0 sites38 target enrollmentApril 17, 2018

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Patients with end-stage renal disease on hemodialysis with intradialytic hypertension
Sponsor: Aristotle University of Thessaloniki School of Medicine
Enrollment: 38
Status: Completed
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

April 17, 2018

End Date

April 30, 2018

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Aristotle University of Thessaloniki School of Medicine

•1\. Adult aged \>18 years
•2\. End\-stage renal disease treated with thrice\-weekly maintenance hemodialysis for more than 3 months
•3\. Intradialytic hypertension (defined as mean intradialytic rise \=10 mmHg in systolic BP in at least 4 over 6 consecutive hemodialysis sessions)

•1\. Existing comorbidity requiring treatment with a RAS\-blocker (i.e. heart failure, acute myocardial infraction e.t.c.)
•2\. Existing comorbidity requiring treatment with a ß\-blocker (i.e. heart failure, cardiac arrhythmia, acute myocardial infarction, angina pectoris, etc.)
•3\. Existing specific contraindications to receive a RAS\-blocker (i.e. history of hyperkalemia, angioedema, anaphylactic or allergic reaction)
•4\. Existing specific contraindications to receive a ß\-blocker (bradyarrhythmia, chronic obstructive pulmonary disease, asthma, history of anaphylactic or allergic reaction)
•5\. Antihypertensive treatment with RAS\-blockers (angiotensin\-converting enzyme inhibitors, angiotensin II receptor blockers or renin\-inhibitor) or ß\-blockers in a period less than one month prior to study enrollment.
•6\. Pre\- or post\-hemodialysis SBP levels \<130mmHg in 4 out of 6 sessions during the two weeks of the diagnosis of intradialytic hypertension
•7\. Nonfunctional arteriovenous fistula in the contralateral arm of the one used as vascular access for the hemodialysis session that could interfere with proper ABPM recordings.
•8\. Active malignant disease or other advanced comorbidity resulting in particularly poor prognosis
•9\. Inability to understand and provide a written informed consent to participate in the study