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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: NCT05234788 Not yet recruiting - Clinical trials for Uncontrolled Hypertension

Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

RADIUS-HTN
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study in patients with uncontrolled hypertension to compare the safety and efficacy of radio frequency renal denervation using Iberis Renal Denervation System via radial access compared with femoral access.

NCT ID: NCT04321044 Active, not recruiting - Hypertension Clinical Trials

Genetic Based Analysis in Hypertensive Patients

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Many attempts to identify predictors of blood pressure response after renal denervation failed to identify a meaningful determination of blood pressure response. These attempts have been based on demographic parameters, clinical parameters, endocrine inflammatory and other biochemical variables, comorbidities and disease factors. So far the only predictor of blood pressure response is the pre-treatment blood pressure. According to Wilder's law the pre-treatment baseline value is always a determinant for any change due to an intervention, irrespective which biological variable is examined. The investigators propose a genetic approach to identify predictors of blood pressure response after renal denervation. Genetic factors are not subject to changes of clinical parameters, previous or current antihypertensive therapy, hypertension associated organ damages, comorbidities and other potential clinical variables.

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: NCT04264403 Active, not recruiting - Clinical trials for Uncontrolled Hypertension

Renal Denervation in Chronic Kidney Disease - RDN-CKD Study

RDN-CKD
Start date: January 23, 2020
Phase: N/A
Study type: Interventional

RDN-CKD Study is a prospective, randomized (1:1, central randomization), double-blind (unblinded interventionalist and blinded study team at each center), sham controlled, multicenter feasibility study. The purpose of the RDN-CKD Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 80 patients with chronic kidney disease (CKD) stage 3a or 3b.

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: NCT02496117 Completed - Hypertension Clinical Trials

Renal Nerves Stimulation Study

RNS
Start date: March 14, 2014
Phase: Phase 2
Study type: Interventional

Study design: Investigator initiated, single centre, feasibility study Main objectives are twofold: 1. To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities. 2. To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures. Study population: 40 patients (18 - 80 yr old)

NCT ID: NCT01874470 Terminated - Clinical trials for Resistant Hypertension

Renal Denervation by Allegro System in Patients With Resistant Hypertension

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system