Effects of Spironolactone on Arrhythmias in Hemodialysis Patients: Secondary Results of the SPin-D Randomized Controlled Trial.
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SUBMITTER: Mc Causland FR
PROVIDER: S-EPMC10278797 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
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Effects of Spironolactone on Arrhythmias in Hemodialysis Patients: Secondary Results of the SPin-D Randomized Controlled Trial.
Mc Causland Finnian R FR Hsu Jesse Y JY Himmelfarb Jonathan J Ikizler Talat Alp TA Raj Dominic S DS Mehrotra Rajnish R Mehrotra Rajnish R Waikar Sushrut S SS Waikar Sushrut S SS Kimmel Paul L PL Kliger Alan S AS Dember Laura M LM Charytan David M DM
Kidney360 20230210 4
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Project description: Not available
| S-EPMC10278809 | biostudies-literature
Project description:BackgroundThe role of spironolactone treatment in hemodialysis patients is debated, but a survival benefit is suggested. Mineralocorticoids and chronic kidney disease have been linked to cardiovascular fibrosis. Therefore, we hypothesized that spironolactone would affect vascular stiffness, cardiac systolic, and diastolic function in hemodialysis patients.MethodsThis was a randomized crossover study in hemodialysis patients supplemented with an echocardiographic case series. All outcomes reported here were secondary in the trial and were assessed without blinding. Block randomization and allocation determined treatment order. Participants received 50 mg spironolactone daily for 12 weeks and untreated observation for another 12 weeks. Pulse wave velocity (PWV) was measured before and after treatment and observation. Doppler-echocardiography was conducted before and after treatment. Systemic arterial compliance indexed to body surface area (SACi), left ventricular ejection fraction (LVEF), the peak early diastolic mitral inflow velocity (E), the peak late diastolic mitral inflow velocity (A), and the peak early diastolic myocardial lengthening velocity (E') were measured. E/A and E/E' were then calculated. Statistical analyses were conducted per protocol. A generalized linear mixed model with random participant effects was used for PWV. The Wilcoxon signed-rank test was used for echocardiographic variables.ResultsThirty participants were recruited, 18 completed follow-up, and 17 were included in PWV-analyses. Spironolactone treatment showed a tendency toward an increase in PWV of 1.34 (95% confidence interval: -0.11 to 2.78) m/s, which was not statistically significant (P = 0.07). There were no significant changes in any of the other variables (LVEF, E/A, E/E', or SACi).ConclusionsWe found no evidence supporting an effect of 12-week administration of spironolactone 50 mg daily on vascular stiffness, cardiac systolic, or diastolic function in hemodialysis patients.
| S-EPMC9169545 | biostudies-literature
Project description:The safety and efficacy of spironolactone is uncertain in end-stage renal disease. We randomized 129 maintenance hemodialysis patients to placebo (n=51) or spironolactone 12.5 mg (n=27), 25 mg (n=26), or 50 mg (n=25) daily for 36 weeks in a double-blind, placebo-controlled, multiple dosage trial to assess safety, tolerability and feasibility and to explore cardiovascular efficacy. The primary safety endpoints were hyperkalemia (potassium > 6.5 mEq/L) and hypotension requiring emergency department visit or hospitalization. Diastolic function was assessed by Doppler echocardiography. 125 participants (97%) completed dose escalation, with no significant difference in permanent study drug discontinuation between the groups (27.5% in placebo versus 16.7% in the combined spironolactone groups and 28% in the 50 mg group). Hyperkalemia frequency was similar between spironolactone and placebo (0.49 versus 0.50 events per patient-year) but demonstrated a significant linear trend due primarily to an increased event rate at the 50 mg dose (0.89 events per patient-year). The primary hypotension outcome was infrequent and similar with spironolactone and placebo (0.11 versus 0 events per patient-year). Gynecomastia was rare and did not differ significantly between groups. Change in diastolic function was similar with spironolactone and placebo. Spironolactone appears safe in carefully monitored maintenance hemodialysis patients, but did not affect cardiovascular parameters in this small study. Hyperkalemia occurs more frequently as dosage increases to 50 mg daily.
| S-EPMC6431563 | biostudies-literature
Project description:BACKGROUND: Magnesium salts bind dietary phosphorus, but their use in renal patients is limited due to their potential for causing side effects. The aim of this study was to evaluate the efficacy and safety of magnesium carbonate (MgCO(3)) as a phosphate-binder in hemodialysis patients. METHODS: Forty-six stable hemodialysis patients were randomly allocated to receive either MgCO(3) (n=25) or calcium carbonate (CaCO(3)), (n=21) for 6 months. The concentration of Mg in the dialysate bath was 0.30 mmol/l in the MgCO(3) group and 0.48 mmol/l in the CaCO(3) group. RESULTS: Only two of 25 patients (8%) discontinued ingestion of MgCO(3) due to complications: one (4%) because of persistent diarrhea, and the other (4%) because of recurrent hypermagnesemia. In the MgCO(3) and CaCO(3) groups, respectively, time-averaged (months 1-6) serum concentrations were: phosphate (P), 5.47 vs. 5.29 mg/dl, P=ns; Ca, 9.13 vs. 9.60 mg/dl, P<0.001; Ca x P product, 50.35 vs. 50.70 (mg/dl)(2), P=ns; Mg, 2.57 vs. 2.41 mg/dl, P=ns; intact parathyroid hormone (iPTH), 285 vs. 235 pg/ml, P<0.01. At month 6, iPTH levels did not differ between groups: 251 vs. 212 pg/ml, P=ns. At month 6 the percentages of patients with serum levels of phosphate, Ca x P product and iPTH that fell within the Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines were similar in both groups, whereas more patients in the MgCO(3) group (17/23; 73.91%) than in the CaCO(3) group (5/20, 25%) had serum Ca levels that fell within these guidelines, with the difference being significant at P<0.01. CONCLUSION: Our study shows that MgCO(3) administered for a period of 6 months is an effective and inexpensive agent to control serum phosphate levels in hemodialysis patients. The administration of MgCO(3) in combination with a low dialysate Mg concentration avoids the risk of severe hypermagnesemia.
| S-EPMC2268719 | biostudies-other
Project description:ObjectiveBoth renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension.MethodsA total of 24 patients with office SBP at least 150?mmHg and 24-h SBP at least 140?mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50?mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values.ResultsSpironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were -17.9?mmHg (95%CI -30.9 to -4.9); P?=?0.010 and -6.6?mmHg (95%CI -12.9 to -0.3); P?=?0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were -12.1?mmHg (95%CI -29.1 to 5.1); P?=?0.158 and of -5.3?mmHg (95%CI -16.3 to 5.8); P?=?0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was -10.7?ml/min per 1.73 m (95%CI -20.1 to -1.4); P?=?0.027.ConclusionWe conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN.
| S-EPMC4972478 | biostudies-literature
Project description:Changes in gene expression were consistent with mechanism of action and show that clinical response to treatment with belimumab is associated with significant decrease in profibrotic genes and pathways. Additional study is needed to determine the role of belimumab in the treatment of dcSSc
2018-03-01 | GSE97248 | GEO
Project description:Previous reports have shown the benefits of intradialytic exercise to patients undergoing hemodialysis. However, most of those studies assessed the effects of exercise in middle-aged patients and little is known about advanced-age patients undergoing hemodialysis. Therefore, the present randomized controlled trial was performed to determine the effectiveness of exercise therapy in advanced-age patients undergoing hemodialysis. This non-blinded, randomized controlled parallel trial enrolled a total of 101 patients who were randomly assigned to intradialytic exercise (n = 51) or usual care (n = 50) groups. The training program included both resistance and aerobic exercises and was performed three times per week for 6 months. The aerobic exercise intensity was adjusted to a target Borg score of 13 for 20 minutes. Four types of resistance exercises were performed using elastic tubing, with three sets of 10 exercises performed at moderate intensity (13/20 on the Borg scale). The usual care group received standard care. Lower extremity muscle strength, Short Physical Performance Battery score, and 10-m walking speed were the outcomes and were evaluated before the hemodialysis session and after 6 months of training. There were statistically significant improvements in Short Physical Performance Battery score (effect size, 0.57; 95% confidence interval, 0.15‒1.95) in the exercise group relative to the control group. There were no statistically significant differences in lower extremity muscle strength or in the 10-m walking speed between the two groups. These findings suggest that 6 months of intradialytic training could improve physical function in older patients undergoing hemodialysis.
| S-EPMC8535393 | biostudies-literature
Project description:This study describes the effects of intermittent fasting induced weight loss on metabolic and molecular pathways
2023-07-01 | GSE196335 | GEO
Project description:Few long-term studies have assessed whether changes in both diet and exercise can improve the health and quality of life (QOL) of hemodialysis (HD) patients. Here we examined whether 12 months of intradialytic protein supplementation and endurance exercise improves physical function, risk of cardiovascular disease (CVD), and QOL in HD patients in a randomized controlled trial (RCT). A total of 138 HD patients (average age 58 years) were assigned for 12 months to control, intradialytic protein, or protein plus exercise groups. The protein and protein plus exercise groups consumed an oral protein supplement (30 grams of whey) three days/week during dialysis. The protein plus exercise group cycled for 30-45 minutes during dialysis treatment. The primary outcome was change in physical function at 12 months, assessed by a shuttle walk test. Secondary outcomes included arterial stiffness, blood pressure, body composition, muscle strength, markers of nutritional status, and QOL. Assessments were conducted at baseline, 6 and 12 months. In total, 101 patients completed the intervention. There were no significant differences between groups in shuttle walk test performance from baseline to 12 months. There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance. Thus, our trial did not demonstrate significant improvements in markers of physical function, risk of CVD or QOL after one year of intradialytic oral OPS and aerobic exercise training. More comprehensive lifestyle management may be needed to uncover robust improvements in the health and QOL of HD patients.
| S-EPMC6708720 | biostudies-literature
Project description:Hypertension is a common complication of chronic kidney disease and persists among most patients with end-stage renal disease despite the provision of conventional thrice weekly hemodialysis (HD). We analyzed the effects of frequent HD on blood pressure in the randomized controlled Frequent Hemodialysis Network trials. The daily trial randomized 245 patients to 12 months of 6× ("frequent") vs. 3× ("conventional") weekly in-center hemodialysis; the nocturnal trial randomized 87 patients to 12 months of 6× weekly nocturnal HD vs. 3× weekly predominantly home-based hemodialysis. In the daily trial, compared with 3× weekly HD, 2 months of frequent HD lowered predialysis systolic blood pressure by -7.7 mmHg [95% confidence interval (CI): -11.9 to -3.5] and diastolic blood pressure by -3.9 mmHg [95% CI: -6.5 to -1.3]. In the nocturnal trial, compared with 3× weekly HD, 2 months of frequent HD lowered systolic blood pressure by -7.3 mmHg [95% CI: -14.2 to -0.3] and diastolic blood pressure by -4.2 mmHg [95% CI: -8.3 to -0.1]. In both trials, blood pressure treatment effects were sustained until month 12. Frequent HD resulted in significantly fewer antihypertensive medications (daily: -0.36 medications [95% CI: -0.65 to -0.08]; nocturnal: -0.44 mediations [95% CI: -0.89 to -0.03]). In the daily trial, the relative risk per dialysis session for intradialytic hypotension was lower with 6×/week HD but given the higher number of sessions per week, there was a higher relative risk for intradialytic hypotensive requiring saline administration. In summary, frequent HD reduces blood pressure and the number of prescribed antihypertensive medications.
| S-EPMC4490029 | biostudies-literature