Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartan on
Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled
One-Year Intervention Trial (the SAFIR Study).
Author(s): Peters CD(1), Kjaergaard KD(1), Jensen JD(1), Christensen KL(2), Strandhave C(3),
Tietze IN(4), Novosel MK(5), Bibby BM(6), Jespersen B(1).
Affiliation(s): Author information:
(1)Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark;
Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark. (2)Department
of Cardiology, Aarhus University Hospital, Aarhus, Denmark. (3)Department of
Nephrology, Aalborg University Hospital, Aalborg, Denmark. (4)Department of
Medicine, Viborg Regional Hospital, Viborg, Denmark. (5)Department of Medicine,
Fredericia Hospital, Fredericia, Denmark. (6)Department of Biostatistics, Aarhus
University, Aarhus, Denmark.
Publication date & source: 2015, PLoS One. , 10(6):e0126882
BACKGROUND AND AIM: Little is known about the tolerability of antihypertensive
drugs during hemodialysis treatment. The present study evaluated the use of the
angiotensin II receptor blocker (ARB) irbesartan.
DESIGN: Randomized, double-blind, placebo-controlled, one-year intervention
trial.
SETTING AND PARTICIPANTS: Eighty-two hemodialysis patients with urine output >300
mL/day and dialysis vintage <1 year.
INTERVENTION: Irbesartan/placebo 300 mg/day for 12 months administered as add-on
to antihypertensive treatment using a predialytic systolic blood pressure target
of 140 mmHg in all patients.
OUTCOMES AND MEASUREMENTS: Cardiac output, stroke volume, central blood volume,
total peripheral resistance, mean arterial blood pressure, and frequency of
intradialytic hypotension.
RESULTS: At baseline, the groups were similar regarding age, comorbidity, blood
pressure, antihypertensive medication, ultrafiltration volume, and dialysis
parameters. Over the one-year period, predialytic systolic blood pressure
decreased significantly, but similarly in both groups. Mean start and mean end
cardiac output, stroke volume, total peripheral resistance, heart rate, and mean
arterial pressure were stable and similar in the two groups, whereas central
blood volume increased slightly but similarly over time. The mean hemodynamic
response observed during a dialysis session was a drop in cardiac output, in
stroke volume, in mean arterial pressure, and in central blood volume, whereas
heart rate increased. Total peripheral resistance did not change significantly.
Overall, this pattern remained stable over time in both groups and was
uninfluenced by ARB treatment. The total number of intradialytic hypotensive
episodes was (placebo/ARB) 50/63 (P = 0.4). Ultrafiltration volume, left
ventricular mass index, plasma albumin, and change in intradialytic total
peripheral resistance were significantly associated with intradialytic
hypotension in a multivariate logistic regression analysis based on baseline
parameters.
CONCLUSION: Use of the ARB irbesartan as an add-on to other antihypertensive
therapy did not significantly affect intradialytic hemodynamics, neither in short
nor long-term, and no significant increase in hypotensive episodes was seen.
TRIAL REGISTRATION: Clinicaltrials.gov NCT00791830.
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