Effect of enalapril on the progression of chronic renal failure. A randomized controlled trial.

In order to study the influence of angiotensin converting enzyme (ACE) inhibition on the progression of chronic nephropathy, 70 patients with a median glomerular filtration rate (GFR) of 15 (range, 6 to 54) mL/min/1.73 m2 were randomized in an open study to basic treatment with enalapril or conventional antihypertensive treatment. The patients were followed for at least 2 years or until they needed dialysis. The groups were comparable with respect to age and sex distribution, etiology of renal diseases, initial levels of renal function and arterial blood pressure (BP), and protein intake. The therapeutic goal was a BP of 120 to 140/80 to 90 mm Hg. The GFR, estimated by the plasma clearance of 51Cr-EDTA, was measured every third month, and the individual rate of progression was calculated as the slope of the GFR v time plot. In the enalapril group, the median decline in GFR was -0.20 (range, +0.18 to -7.11) mL/min/1.73 m2/month and in the control group it was -0.31 (+0.01 to -1.97) mL/min/1.73 m2/month (P less than .05). There was no significant difference in blood pressure or plasma lipid levels between the groups. Thus, the progression of moderate to severe chronic nephropathy was slower on a basic treatment with enalapril as compared to conventional antihypertensive therapy.     

A randomized controlled trial of two schedules of hepatitis B vaccination in predialysed chronic renal failure patients

Background

Patients with chronic renal disease should be vaccinated as soon as dialysis is forestalled, and this could improve the seroconversion of hepatitis B vaccination.

Objectives

In this study, we aimed to compare seroconversion and immune response rates using 4 doses of 40 μg and 3 doses of 20 μg Euvax B recombinant Hepatitis B surface Antigen (HBs Ag) vaccine administered to predialysis patients with chronic kidney disease (CKD).

Patients and Methods

In an open, randomized clinical trial, we compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure who received either 4 doses of 40 μg or 3 doses of 20 μg of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months, respectively.

Results

Differences in seroconversion rates after 4 doses of 40 μg (80.88%) compared to 3 doses of 20 μg (92%) were not significant (P = 0.4124). The mean HBs antibody level after 4 doses of 40 μg at 0, 1, 2, and 6 months (182.2 ± 286.7) was significantly higher than that after 3 doses of 40 μg at 0,1, and 6 months (96.9 ± 192.1) (P = 0.004). Seroconversion after 4 doses of 40 μg (80.8%) was also significantly higher than that after 3 doses of 40 μg (77%) (P = 0.004). Multivariable analysis showed that none of the variables contributed to seroconversion.

Conclusions

We found that 4 doses of 40 μg did not lead to significantly more seroconversion than 3 doses of 20 μg.     

Usefulness of rotational spin for coronary angiography in patients with advanced renal insufficiency

Coronary angiography in patients with advanced renal insufficiency is typically restricted to cases of life-threatening circumstances such as acute myocardial infarction and unstable angina. To gather a large amount of visual information with a minimum number of cine runs, and consequently, with a minimum volume of contrast medium, we rotated the gantry at 40 degrees /s throughout an angle of 120 degrees, from the right toward the left anterior oblique positions. This technique of rotational spin during cinegraphic runs has not yet become established in invasive cardiology. Three experienced cardiologists independently evaluated all coronary segments in rotational versus standard coronary angiography modes for 15 patients, on the basis of an 11-point scale (0 = cardiac spin far better to 10 = standard mode far better). A score of 5 signified that there was no difference in quality between the 2 modes. The arithmetic mean of the assessment values was 4.9 +/- 0.3 for coronary segments, 5.4 +/- 1.3 for coronary lesions, 5.1 +/- 1.4 for bifurcations, and 5.0 +/- 0.1 for coronary flow. The arithmetic means for the volume of contrast medium (25 +/- 4 ml), for the overall dose area product (8.6 +/- 4.5 Gy x cm(2)), and for the number of cine graphic frames (203 +/- 65) for a diagnostic cardiac spin were significantly below published typical values in standard mode. Cardiac spin enables 3-dimensional coronary impression under conditions of adequate image quality and represents a new, useful, and beneficial method in invasive cardiology for applications involving the special indication of advanced renal insufficiency.     

Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: the RECOVER study: a randomized controlled trial.

OBJECTIVES: This study sought to compare the nephrotoxicity of iodixanol and ioxaglate in patients with renal impairment undergoing coronary angiography. BACKGROUND: Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than low-osmolar contrast media (LOCM) in high-risk patients. METHODS: In a prospective, randomized trial in 300 adults with creatinine clearance (CrCl) < or =60 ml/min, patients received either iodixanol or ioxaglate and underwent coronary angiography with or without percutaneous coronary intervention. The primary end point was the incidence of contrast-induced nephropathy (CIN) (an increase in serum creatinine [SCr] > or =25% or > or =0.5 mg/dl [> or =44.2 mumol/l]). The incidence of CIN in patients with severe renal impairment at baseline (CrCl <30 ml/min) or diabetes and in those receiving large doses (> or =140 ml) of contrast medium was also determined. RESULTS: The incidence of CIN was significantly lower with iodixanol (7.9%) than with ioxaglate (17.0%; p = 0.021), corresponding to an odds ratio (OR) of CIN of 0.415 (95% confidence interval [CI] 0.194 to 0.889) for iodixanol. The incidence of CIN was also significantly lower with iodixanol in patients with severe renal impairment (p = 0.023) or concomitant diabetes (p = 0.041), or in patients given > or =140 ml of contrast media (p = 0.038). Multivariate analysis identified use of ioxaglate (OR 2.65, 95% CI 1.11 to 6.33, p = 0.028), baseline SCr, mg/dl (OR 2.0, 95% CI 1.04 to 3.85, p = 0.038), and left ventricular ejection fraction, % (OR 0.97, 95% CI 0.94 to 0.99, p = 0.019) as independent risk factors for CIN. CONCLUSIONS: The IOCM iodixanol was significantly less nephrotoxic than ioxaglate, an ionic, dimeric LOCM. (The RECOVER Trial; http://clinicaltrials.gov; NCT00247325).     

Pilates in heart failure patients: a randomized controlled pilot trial

Background: Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Purpose: Investigate the effects of Pilates on exercise capacity variables in HF. Methods: Sixteen pts with HF, left ventricular ejection fraction 27 ± 14%, NYHA class I-II were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. Results: At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 ± 2.5 to 17.8 ± 4 and 11.7 ± 3.9 to 14.2 ± 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 ± 20 to 69 ± 17 L/min, P= 0.02), peak VO(2) (from 20.9 ± 6 to 24.8 ± 6 mL/kg/min, P= 0.01), and O(2) pulse (from 11.9 ± 2 to 13.8 ± 3 mL/bpm, P= 0.003). The Pilates group showed significantly increase in peak VO(2) when compared with conventional group (24.8 ± 6 vs. 18.3 ± 4, P= 0.02). Conclusions: The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy.     

Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial

Background:Left ventricular hypertrophy and asymmetric dimethylarginine (ADMA) are surrogate markers of cardiovascular disease (CVD) in the dialysis population. This study aimed to evaluate the effect of a calcium channel blocker-based antihypertensive regimen compared to a beta-blocker-based antihypertensive regimen on left ventricular mass index (LVMI) and ADMA levels in hypertensive patients on hemodialysis (HD).Methods:This was a parallel-design, open-label, single-center randomized controlled trial on 46 hypertensive patients on maintenance HD, with no history of CVD. Patients were randomly assigned to receive amlodipine 10 mg/d (n = 23) or bisoprolol 10 mg/d (n = 23). Office-based blood pressure (BP) was targeted to ≤ 140/ 90 mm Hg. The outcome was the change in LVMI and ADMA from baseline to 6 months.Results:Baseline demographic and clinical characteristics did not vary between groups. After 6 months of treatment, amlodipine-based therapy induced a greater reduction in LVMI from baseline than bisoprolol-based treatment (35 ± 34.2 vs 9.8 ± 35.9 gm/m²; P = .017). A similar reduction in the mean BP occurred with treatment in both groups. ADMA concentration decreased significantly from baseline in the amlodipine group (0.75 ± 0.73 to 0.65 ± 0.67 nmol/mL; P = .001), but increased nonsignificantly in the bisoprolol group (0.64 ± 0.61 to 0.78 ± 0.64 nmol/mL; P = .052).Conclusion:This study showed that compared to a bisoprolol-based regimen, an amlodipine-based antihypertensive regimen resulted in a significantly greater reduction in LVMI and ADMA levels from baseline in hypertensive patients on HD despite similar BP reduction in both groups. These findings support the re-evaluation of amlodipine as a potential first-line antihypertensive treatment in patients on HD without previous CVD.Trial Registration:Clinicaltrials.gov Identifier: NCT04085562, registered September 2019.     

Effectiveness of a follow-up program for elderly heart failure patients after hospital discharge. A randomized controlled trial

PurposeManagement programs for high-risk heart failure (HF) patients reduce admission rates, improve quality of life and survival, and lower costs. These benefits are controversial in elderly patients because these individuals are frequently excluded from the studies. Our aim was to evaluate the effectiveness of disease management programs (DMPs) for HF elderly patients attending a geriatric day care hospital (GDCH) subsequent to hospital discharge.MethodsA randomized prospective study was performed using 117 HF patients who were divided into two groups as follows: 59 patients undergoing an interventional program including health education, therapeutic control, and close follow-up in a GDCH; and 58 patients receiving standard healthcare. Results were measured in terms of event-free survival, where “event” is defined as readmission or mortality for any cause.ResultsThe mean age was 85 years, and 73% of the patients were women. After a year of follow-up, the intervention group had fewer patients with events compared with the control group (27 vs. 38 patients), which indicates a 30% reduction (RR: 2.25; 95% CI: 1.07–4.74; P = 0.032). The probability of having an event between the first visit and the year of follow-up was significantly lower in the intervention group (log-rank: 5.79; P = 0.016). Moreover, the quality of life improved significantly in the intervention group (P = 0.035).ConclusionA developed DMP in a GDCH improves the event-free survival and the quality of life in elderly patients with HF.Trial registrationisrctn.org identifier: ISRCTN10823032.     

急性下壁心肌梗死患者经桡动脉使用SAL指引导管直接进行操作的随机对照研究

目的评价经桡动脉使用短头AL(SAL)指引导管对急性下壁心肌梗死患者直接进行冠状动脉造影及经皮冠状动脉介入治疗(PCI)的疗效与安全性。方法入选我院心血管中心收治的急性下壁心肌梗死患者51例,按随机数字表法分成SAL组25例及对照组26例,均采用桡动脉途径,SAL组直接使用SAL指引导管完成冠状动脉造影及PCI,对照组使用多功能造影管完成冠状动脉造影,再根据病变情况选择合适指引导管完成PCI。比较两组患者完成冠状动脉造影所用时间(Time1)、完成球囊扩张所用时间(Time2)以及完成PCI术所用时间(Time3),并观察SAL指引导管的安全性及9个月随访期内的主要不良心血管事件(MACE)。结果 51例患者均成功完成冠状动脉造影及PCI。两组患者Time1差异无统计学意义,SAL组Time2[(10.64±2.16)min比(13.85±1.95)min]及Time3[(23.88±4.83)min比(28.50±6.77)min]均显著低于对照组(均为P<0.05)。SAL组患者均未发生冠状动脉开口或近端夹层,住院期间未发生死亡及支架内血栓;对照组死亡1例。其他患者在9个月随访期间均未发生MACE。结论在急性下壁心肌梗死患者中,经桡动脉使用SAL指引导管直接进行介入诊疗操作可能是一种安全有效的方法。     

Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal bleeding. At 31 hospitals in an emergency setting, 256 patients (Child-Pugh > 8; Child-Pugh B = 26%, C = 74%) were randomized equally to: placebo; 600 microg/kg rFVIIa (200 + 4x 100 microg/kg); or 300 microg/kg rFVIIa (200 + 100 microg/kg). Dosing was intravenous at 0, 2, 8, 14, and 20 hours after endoscopy, in addition to standard vasoactive, prophylactic antibiotic, and endoscopic treatment. The primary composite endpoint consisted of failure to control 24-hour bleeding, or failure to prevent rebleeding or death at day 5. Secondary endpoints included adverse events and 42-day mortality. Baseline characteristics were comparable between groups. Administration of rFVIIa had no significant effect on the composite endpoint compared with placebo (P = 0.37). There was no significant difference in 5-day mortality between groups; however, 42-day mortality was significantly lower with 600 microg/kg rFVIIa compared with placebo (odds ratio 0.31, 95% confidence interval = 0.13-0.74), and bleeding-related deaths were reduced from 12% (placebo) to 2% (600 microg/kg). A marked heterogeneity in the failure rate in all treatment groups was observed across participating centers. Adverse events, including overall thromboembolic events, were comparable between groups. CONCLUSION: Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo. Therefore, decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered, because results of this study do not support the routine use of rFVIIa in this setting. Adverse events were comparable across groups.     

A randomized controlled trial of adaptive ventilation for Cheyne-Stokes breathing in heart failure

Heart failure is associated with Cheyne-Stokes breathing, which fragments patients' sleep. Correction of respiratory disturbance may reduce sleep fragmentation and excessive daytime sleepiness. This randomized prospective parallel trial assesses whether nocturnal-assist servoventilation improves daytime sleepiness compared with the control. A total of 30 subjects (29 male) with Cheyne-Stokes breathing (mean apnea-hypopnea index 19.8 [SD 2.6] and stable symptomatic chronic heart failure (New York Heart Association Class II-IV) were treated with 1 month's therapeutic (n = 15) or subtherapeutic adaptive servoventilation. Daytime sleepiness (Osler test) was measured before and after the trial with change in measured sleepiness the primary endpoint. Secondary endpoints included brain natriuretic peptide levels and catecholamine excretion. Active treatment reduced excessive daytime sleepiness; the mean Osler change was +7.9 minutes (SEM 2.9), when compared with the control, the change was -1.0 minutes (SEM, 1.7), and the difference was 8.9 minutes (95% confidence interval, 1.9-15.9 minutes; p = 0.014, unpaired t test). Significant falls occurred in plasma brain natriuretic peptide and urinary metadrenaline excretion. We conclude that adaptive servoventilation produces an improvement in excessive daytime sleepiness in patients with Cheyne-Stokes breathing and chronic heart failure. This study suggests improvements in neurohormonal activation with this treatment.     

Valsartan cardio-renal protection in patients undergoing coronary angiography complicated with chronic renal insufficiency (VAL-CARP) trial: rationale and design.

BACKGROUND: Despite an increase in the frequency of coronary angiography (CAG) in Japan, the exact incidence of contrast-induced nephropathy (CIN) remains unknown in the Japanese population, especially in patients with chronic renal insufficiency. In addition, the nature of pharmacological interventions that would benefit the patients before or after procedures such as coronary bypass graft (CABG) and percutaneous coronary intervention (PCI) has not been fully investigated. METHODS: In the trial 500 patients with renal insufficiency (defined as a glomerular filtration rate (GFR) of between 89 and 30 ml . min(-1) . (1.73 m(-2)) following CAG will be randomly assigned to receive either valsartan, an angiotensin receptor blocker or angiotensin converting enzyme (ACE) inhibitor plus valsartan.1 The primary end-point is a change in the GFR of patients, which will be followed up for 3 years, including following CABG surgery or PCI. The incidence of cardiac events as well as the adverse effects of pharmacological intervention will be evaluated. In addition, the incidence of renal artery stenosis at the time of CAG will be reported also; however, the patients with renal artery stenosis will be excluded from the present study. CONCLUSION: The present study will provide data on: 1) the exact incidence and course of renal function of CIN after CAG; and 2) the comparative therapeutic benefit of pharmacological intervention with valsartan alone or with valsartan and an ACE inhibitor in combination in patients with coexisting coronary artery diseases and chronic renal insufficiency, regardless of whether they receive CABG or PCI. In addition to these studies, an estimate of the incidence of renal artery stenosis in these patients will be demonstrated.