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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).

ABSTRACT: 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.Randomized, double-blind, placebo-controlled, one-year intervention trial.Eighty-two hemodialysis patients with urine output >300 mL/day and dialysis vintage <1 year.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.Cardiac output, stroke volume, central blood volume, total peripheral resistance, mean arterial blood pressure, and frequency of intradialytic hypotension.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.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.Clinicaltrials.gov NCT00791830.

SUBMITTER: Peters CD

PROVIDER: S-EPMC4452642 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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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).

Peters Christian Daugaard CD Kjaergaard Krista Dybtved KD Jensen Jens Dam JD Christensen Kent Lodberg KL Strandhave Charlotte C Tietze Ida Noerager IN Novosel Marija Kristina MK Bibby Bo Martin BM Jespersen Bente B

PloS one 20150601 6

<h4>Background and aim</h4>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.<h4>Design</h4>Randomized, double-blind, placebo-controlled, one-year intervention trial.<h4>Setting and participants</h4>Eighty-two hemodialysis patients with urine output >300 mL/day and dialysis vintage <1 year.<h4>Intervention</h4>Irbesartan/placebo 300 mg/day for 12 months admini ...[more]

PMID: 26030651

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Project description:BackgroundIrbesartan, a long acting selective angiotensin-1 receptor inhibitor, in Marfan syndrome might reduce aortic dilatation, which is associated with dissection and rupture. We aimed to determine the effects of irbesartan on the rate of aortic dilatation in children and adults with Marfan syndrome.MethodsWe did a placebo-controlled, double-blind randomised trial at 22 centres in the UK. Individuals aged 6-40 years with clinically confirmed Marfan syndrome were eligible for inclusion. Study participants were all given 75 mg open label irbesartan once daily, then randomly assigned to 150 mg of irbesartan (increased to 300 mg as tolerated) or matching placebo. Aortic diameter was measured by echocardiography at baseline and then annually. All images were analysed by a core laboratory blinded to treatment allocation. The primary endpoint was the rate of aortic root dilatation. This trial is registered with ISRCTN, number ISRCTN90011794.FindingsBetween March 14, 2012, and May 1, 2015, 192 participants were recruited and randomly assigned to irbesartan (n=104) or placebo (n=88), and all were followed for up to 5 years. Median age at recruitment was 18 years (IQR 12-28), 99 (52%) were female, mean blood pressure was 110/65 mm Hg (SDs 16 and 12), and 108 (56%) were taking β blockers. Mean baseline aortic root diameter was 34·4 mm in the irbesartan group (SD 5·8) and placebo group (5·5). The mean rate of aortic root dilatation was 0·53 mm per year (95% CI 0·39 to 0·67) in the irbesartan group compared with 0·74 mm per year (0·60 to 0·89) in the placebo group, with a difference in means of -0·22 mm per year (-0·41 to -0·02, p=0·030). The rate of change in aortic Z score was also reduced by irbesartan (difference in means -0·10 per year, 95% CI -0·19 to -0·01, p=0·035). Irbesartan was well tolerated with no observed differences in rates of serious adverse events.InterpretationIrbesartan is associated with a reduction in the rate of aortic dilatation in children and young adults with Marfan syndrome and could reduce the incidence of aortic complications.FundingBritish Heart Foundation, the UK Marfan Trust, the UK Marfan Association.

Project description:ObjectiveTo evaluate the effect of angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB) therapy on the prognosis of patients with atrial fibrillation (AF).MethodsA total of 1, 991 AF patients from the AF registry were divided into two groups according to whether they were treated with ACEI/ARB at recruitment. Baseline characteristics were carefully collected and analyzed. Logistic regression was utilized to identify the predictors of ACEI/ARB therapy. The primary endpoint was all-cause mortality, while the secondary endpoints included cardiovascular mortality, stroke and major adverse events (MAEs) during the one-year follow-up period. Univariable and multivariable Cox regression were performed to identify the association between ACEI/ARB therapy and the one-year outcomes.ResultsIn total, 759 AF patients (38.1%) were treated with ACEI/ARB. Compared with AF patients without ACEI/ARB therapy, patients treated with ACEI/ARB tended to be older and had a higher rate of permanent AF, hypertension, diabetes mellitus, heart failure (HF), left ventricular ejection fraction (LVEF) < 40%, coronary artery disease (CAD), prior myocardial infarction (MI), left ventricular hypertrophy, tobacco use and concomitant medications (all P < 0.05). Hypertension, HF, LVEF < 40%, CAD, prior MI and tobacco use were determined to be predictors of ACEI/ARB treatment. Multivariable analysis showed that ACEI/ARB therapy was associated with a significantly lower risk of one-year all-cause mortality [hazard ratio (HR) (95% CI): 0.682 (0.527-0.882), P = 0.003], cardiovascular mortality [HR (95% CI): 0.713 (0.514-0.988), P = 0.042] and MAEs [HR (95% CI): 0.698 (0.568-0.859), P = 0.001]. The association between ACEI/ARB therapy and reduced mortality was consistent in the subgroup analysis.ConclusionsIn patients with AF, ACEI/ARB was related to significantly reduced one-year all-cause mortality, cardiovascular mortality and MAEs despite the high burden of cardiovascular comorbidities.

Dataset Information

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).

Publications

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).

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