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Renal Denervation clinical trials

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NCT ID: NCT06208501 Recruiting - Hypertension Clinical Trials

The Predictive Role of Proteomics in Blood Pressure Response of Hypertensive Patients Undergoing Renal Denervation.

PREDICT-RDN
Start date: September 1, 2023
Phase:
Study type: Observational

Renal sympathetic nervous activity plays a crucial role in the development and maintenance of hypertension (HTN). Renal denervation (RDN) is a minimally invasive catheter-based treatment using mainly radiofrequency or ultrasound energy to selectively disrupt the sympathetic renal nerves. RDN has experienced rises and falls during its development as a treatment option for HTN in humans. Latest well-designed sham-controlled randomised trials with improved methodology confirmed significant blood pressure (BP) reduction in both office and 24-hour ambulatory BP. Although the safety of RDN procedures seems favourable thus, the rate of BP response to the procedure is variable, with response rates reported in the range between 60% and 70%. It is of great importance to identify biomarkers able to reliably predict subjects who would benefit from this treatment, in order to achieve better therapeutic results. Proteomics is the study of the full complement of proteins produced or modified by a biological system (cell, tissue, organ, biological fluid, or organism). Proteomic analysis is used in different research settings to understand pathogenicity mechanisms and emerge biomarkers with predictive role in diagnosis and treatment of different diseases. The main purpose of this study is to investigate the potential predictive role of the urine proteomics in BP response of patients undergoing RDN. This hypothesis may lead to the emergence of biomarkers in urine of hypertensive patients, in order to optimally select those who will undergo RDN. This is a prospective observational study enrolling hypertensive patients, aged 18-80 years who will proceed in RDN as participants of randomized control trials. During baseline evaluation HTN diagnosis will be confirmed by office blood pressure measurement (OBPM) and ambulatory blood pressure measurement (ABPM), while urine sample will be collected before RDN for proteomic analysis. The participants will have a follow-up visit in 3 months since baseline procedure for office blood pressure (OBP) and ambulatory blood pressure (ABP) measurements. A cut off value of 5mmHg reduction in ABP or/and 10mmHg reduction in office blood pressure (OBP) on 3 months visit will be set to categorize the patients to responders or non-responders after RDN. The qualitative and quantitative differences of proteins between the two groups of patients will be investigated, based on proteomic analysis results, in order to determine specific urine proteins with predictive role in blood pressure response. The study results are expected to determine the predictive role of urine proteomics in optimal selection of hypertensive patients who will undergo renal denervation.

NCT ID: NCT05715697 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

RDN-HFPEF
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

NCT ID: NCT05460169 Recruiting - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

Renal Denervation in ADPKD- RDN-ADPKD Study

RDN-ADPKD
Start date: June 14, 2022
Phase: N/A
Study type: Interventional

RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-center, hypothesis-generating, feasibility study. The purpose of the RDN-ADPKD study is to demonstrate efficacy and document safety of renal denervation (RDN) with the Paradise System in hypertensive patients with ADPKD.

NCT ID: NCT04314557 Recruiting - Hypertension Clinical Trials

Renal Arterial Denervation in Sympathetic Dysautonomia

RANSOM
Start date: March 14, 2019
Phase:
Study type: Observational [Patient Registry]

The RANSOM registry is considered as a collection of data with the ultimate purpose of gathering information about the effect of renal denervation in patients of the investigator's center and evaluating the results within the usual clinical practice. The general objective of the study is to evaluate the clinical results (blood pressure, quality of life and levels of catecholamines) as well as safety of renal sympathetic denervation in hypertensive patients, at least in treatment with an antihypertensive drug and with increased variability, considering as such a standard deviation> 10 mmHg for systolic BP and> 5 for diastolic BP of its blood pressure levels, measured by ABPM.

NCT ID: NCT03418415 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Renal Denervation in Patients With Type 2 Diabetes Mellitus

Start date: January 18, 2018
Phase: N/A
Study type: Interventional

Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so we assume that renal denervation (RDN) might improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based RDN on glucose metabolism and insulin sensitivity in patients with T2DM.

NCT ID: NCT01522430 Recruiting - Clinical trials for Resistant Hypertension

Study of Catheter Based Renal Denervation Therapy in Hypertension

DEPART
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation: 1. reduces daytime ambulatory blood pressure, 2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.