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Kidney Disease, Chronic / Heart Failure / HOLTER ECG monitoring · Observational Study
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered but incomplete observational study investigating whether SGLT2 inhibitors modify sympathetic/vagal balance measured by heart rate variability in patients with type 2 diabetes, heart failure, and chronic kidney disease. No results are reported in this registry entry; the study remains active and recruiting or recently closed to recruitment with data collection ongoing. The protocol documents the rationale and planned measurements but cannot support any inference about efficacy or mechanism until primary outcome data are posted.
Observational. Diabete Type 2, Heart Failure, Kidney Disease, Chronic, Cardiorenal Syndrome; age from 18 Years. Intervention: HOLTER ECG monitoring. n = 150. 1 site: Italy.
This is a registered but incomplete observational study investigating whether SGLT2 inhibitors modify sympathetic/vagal balance measured by heart rate variability in patients with type 2 diabetes, heart failure, and chronic kidney disease. No results are reported in this registry entry; the study remains active and recruiting or recently closed to recruitment with data collection ongoing. The protocol documents the rationale and planned measurements but cannot support any inference about efficacy or mechanism until primary outcome data are posted.
Results are not yet reported in this registry record; no efficacy, safety, or mechanistic findings can be extracted.
Once results are posted, this observational study may provide descriptive evidence on whether SGLT2 inhibitors alter autonomic balance as measured by HRV indices. However, the observational design limits causal conclusions; the findings should be interpreted as hypothesis-generating unless corroborated by randomized trials.
This is a registry record for an active observational study with no posted results; it describes planned methodology and rationale only, making it preliminary evidence at best until outcomes are reported.
As stated by the source record.
Quoted from the source exactly as published.
Once results are posted, this observational study may provide descriptive evidence on whether SGLT2 inhibitors alter autonomic balance as measured by HRV indices. However, the observational design limits causal conclusions; the findings should be interpreted as hypothesis-generating unless corroborated by randomized trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07471802). This is a study registration, not published results. Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Diabete Type 2, Heart Failure, Kidney Disease, Chronic, Cardiorenal Syndrome. Interventions: DIAGNOSTIC_TEST: HOLTER ECG monitoring. Primary outcome measures: Assessment of the sympathetic/vagal balance at baseline , 24 hours; Changes the sympathetic/vagal balance during pharmacological treatment with SGLT2 inhibitors , 24 months. Brief summary: The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control. Reduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters. Large randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status. Despite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.
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