Abstract
Background. Diabetic patients with resistant hypertension (RHT) are characterized by a high rate of annual decline in estimated glomerular filtration rate (eGFR) (up to 14 mL/min/1.73 m 2 ). The distal approach to sympathetic renal denervation (RD) reduces blood pressure (BP) to a greater extent compared with standard RD. However, the long-term effect of distal RD on the renal function remains unknown. Aim . The purpose of this study was to evaluate the long-term safety and nephroprotective efficacy profile of distal RD compared to conventional intervention in RHT patients with type 2 diabetes mellitus (T2DM) during a three-year follow-up. Material and Methods. Twenty seven patients (eight men) with true RHT and T2DM were included in a single-arm prospective interventional study (number NCT01499810 at ClinicalTrials.gov) (mean age of 61.6 ± 7.3 years; mean office (systolic/diastolic) BP of 171.8 ± 21.9/87.7 ± 17.7 mmHg; mean eGFR of 72.1 ± 19.9 mL/min/1.73 m²; and glycosylated hemoglobin level (HbA1c) of 6.3 ± 1.1%). Patients were randomized into two comparable groups of distant ( n = 13) and standard RD ( n = 14). Office BP, ABPM, renal Doppler ultrasound, renal function (eGFR (CKD-EPI) and 24-hour urinary albumin excretion (UAE)), and kidney MRI were assessed at baseline and annually during a three-year follow-up. Nineteen patients completed a 36-month follow-up (8 patients were treated by distal RD and 11 patients received the conventional procedure). Results. The change in eGFR during three-year follow-up was insignificant in group of distal RD (-5.3 ± 0.4 mL/min/1.73 m 2 , p = 0.63) and was comparable with the corresponding value in conventional RD group (–6.7 ± 4.2 mL/min/1.73 m 2 , p = 0.3), ( p = 0.7 for intergroup comparison) despite a more powerful decrease in 24-h systolic BP in the distal RD group relative to that in conventional RD group (–25.3 ± 15.3 vs. 4.4 ± 22 mmHg, p = 0.04). The degrees of annual decline in GFR did not differ between the distal RD group and conventional RD group ( p = 0.9) and were –2.7 ± 2.4 mL/min/1.73 m 2 /year and –2.7 ± 4.0 mL/min/1.73 m 2 /year, respectively. No significant changes in renal blood flow, albuminuria, MRI-based kidney size, and the number of patients with albuminuria and renal dysfunction were found during the study. Conclusions. Distal RDN in diabetic patients with RHT had a three-year safety profile and nephroprotective efficacy similar to those when the standard method was used despite a more significant reduction of blood pressure. Both modes of RD are likely to slow the progression of renal dysfunction in these patients.
Highlights
Diabetic patients with resistant hypertension (RHT) are characterized by a high rate of annual decline in estimated glomerular filtration rate
to a greater extent compared with standard renal denervation (RD)
nephroprotective efficacy profile of distal RD compared to conventional intervention in RHT patients
Summary
Исходное обследование проведено у 28 больных РАГ, ассоциированной с СД 2-го типа, госпитализированных в отделение артериальных гипертоний НИИ кардиологии Томского НИМЦ, из которых в двойное слепое рандомизированное контролируемое исследование (рег. номер NCT02667912) были включены 27 человек. Критериями невключения были симптоматическая АГ, низкая приверженность к терапии, гипертония «белого халата», уровень гликозилированного гемоглобина (HbA1c) > 10%, СД 1-го типа, беременность, рСКФ < 30 мл/мин/1,73 м2, указание на острые сосудистые осложнения, нестабильная стенокардия в течение предшествующих 6 мес., хроническая сердечная недостаточность выше 2-го функционального класса ФК (NYHA), тяжелые сопутствующие заболевания, выраженный периферический атеросклероз, ятрогенный характер РАГ. Все пациенты принимали статины и были инструктированы не менять режим терапии на протяжении всего исследования. Непрерывные переменные при нормальном распределении представлены как M ± SD, где М – среднее арифметическое, SD – стандартное отклонение или в виде средней и 95% доверительных интервалов M [95% ДИ] (для оценки величины эффекта вмешательства), а при отсутствии нормального распределения – в виде медианы и 25–75% квартилей: Me [25%; 75%]. Использовали непарный t-критерий Стьюдента для независимых выборок, а при отсутствии нормального распределения критерий Манна – Уитни.
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