Renal denervation as a new nephroprotective strategy in diabetic patients with resistant hypertension
A. Yu. Falkovskaya,
V. F. Mordovin,
S. E. Pekarskiy,
T. M. Ripp,
M. A. Manukyan,
V. A. Lichikaki,
E. S. Sitkova,
I. V. Zyubanova,
A. M. Gusakova,
A. E. Baev,
T. R. Ryabova,
N. I. Ryumshina https://doi.org/10.29001/2073-8552-2020-35-1-80-92
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 m2). 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 m2, p = 0.63) and was comparable with the corresponding value in conventional RD group (–6.7 ± 4.2 mL/min/1.73 m2, 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 m2/year and –2.7 ± 4.0 mL/min/1.73 m2/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.
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 m2, p = 0.63) and was comparable with the corresponding value in conventional RD group (–6.7 ± 4.2 mL/min/1.73 m2, 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 m2/year and –2.7 ± 4.0 mL/min/1.73 m2/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.
About the Authors
A. Yu. Falkovskaya
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Senior Research Scientist, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
V. F. Mordovin
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Dr. Sci. (Med.), Head of the Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
S. E. Pekarskiy
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Dr. Sci. (Med.), Leading Research Scientist, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
T. M. Ripp
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Dr. Sci. (Med.), Leading Research Scientist, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
M. A. Manukyan
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Postgraduate Student, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
V. A. Lichikaki
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Research Scientist, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
E. S. Sitkova
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Research Scientist, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
I. V. Zyubanova
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Research Scientist, Department of Hypertension
111a, Kievskaya str., Tomsk, 634012, Russian Federation
A. M. Gusakova
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Research Scientist, Department of Functional and Laboratory Diagnostics
111a, Kievskaya str., Tomsk, 634012, Russian Federation
A. E. Baev
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Cardiologist, Head of Department of Invasive Cardiology
111a, Kievskaya str., Tomsk, 634012, Russian Federation
T. R. Ryabova
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Senior Research Scientist, Department of Functional Diagnostics and Ultrasound
111a, Kievskaya str., Tomsk, 634012, Russian Federation
N. I. Ryumshina
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Russian Federation
Russian Federation
Cand. Sci. (Med.), Research Scientist, Medical Radiologist, Department of Radiology and Tomography
111a, Kievskaya str., Tomsk, 634012, Russian Federation
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For citations:
Falkovskaya A.Yu., Mordovin V.F., Pekarskiy S.E., Ripp T.M., Manukyan M.A., Lichikaki V.A., Sitkova E.S., Zyubanova I.V., Gusakova A.M., Baev A.E., Ryabova T.R., Ryumshina N.I. Renal denervation as a new nephroprotective strategy in diabetic patients with resistant hypertension. Siberian Journal of Clinical and Experimental Medicine. 2020;35(1):80-92. (In Russ.) https://doi.org/10.29001/2073-8552-2020-35-1-80-92
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