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

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).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13587185
Enrollment
38
Registered
2018-04-17
Start date
2016-06-10
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Each participant is evaluated on three different occasions, starting prior to a mid-week hemodialysis session (e.g. the second weekly session, Wednesday or Thursday). Participants receive the study dr

Sponsors

Aristotle University of Thessaloniki School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Ambulatory brachial BP levels are assessed with the Mobil-O-Graph NG device for ABPM at the three study-points. 2. Ambulatory central BP levels are assessed with the Mobil-O-Graph NG device for ABPM at the three study-points. 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

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

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026