The effects of irbesartan and nebivolol on ambulatory blood pressure in patients with intradialytic hypertension.

Phase 4

Completed

• Conditions: Patients with end-stage renal disease on hemodialysis with intradialytic hypertension; Urological and Genital Diseases; End-stage renal disease

• Registration Number: ISRCTN13587185
• Lead Sponsor: Aristotle University of Thessaloniki School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-17
• Study Completion: 2018-04-30
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Ambulatory brachial BP levels are assessed with the Mobil-O-Graph NG device for ABPM at the three study-points.<br>2. Ambulatory central BP levels are assessed with the Mobil-O-Graph NG device for ABPM at the three study-points.<br>3. Ambulatory arterial stiffness parameters (augmentation Index, augmentation pressure and pulse wave velocity) are assessed with the Mobil-O-Graph NG device for ABPM at the three study-points.

Secondary Outcome Measures

Name	Time	Method
1. Plasma renin activity and aldosterone are measured at the start and the end of each hemodialysis session at the three study-points.<br>2. Adrenaline and noradrenaline levels are measured at the start and the end of each hemodialysis session at the three study-points.<br>3. Endothelin and nitric oxide levels are measured at the start and the end of each hemodialysis session at the three study-points.<br>4. Body weight is measured at the start and the end of each hemodialysis session at the three study-points.<br>5. Standard peri-dialytic BP measurements are measured at the three study-points.