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

NCT06208501 | Recruiting

• 1 other identifier: PREDICT-RDN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Renal Denervation; Proteomics

Keywords

Hypertension; Sympathetic nervous system hyperactivity; Renal denervation; Renal nerves ablation; Proteome; Urine proteomics; Proteomic analysis

Outcome Measures

Primary Outcomes (1)

• Identified proteins' variation rate

  In this research protocol the investigators studying urinary proteome changes with potential capacity to predict BP response to RDN procedure. Among the identified proteins in baseline urine, the investigators aim to determine significant proteins' variations between responders and non-responders of BP. Individual proteins will be quantified (μg/g creatinine) by liquid chromatography-mass spectrometry; ELISA and target mass spectrometry analysis will be performed for confirmation. Patients will be classified in responders or non-responders in terms of BP control.

  3 months follow up

Study Arms (1)

Hypertensive patients undergoing renal denervation

Diagnostic Test: Urine sample for proteomic analysis; Diagnostic Test: ABPM; Diagnostic Test: OBPM

Interventions

Urine sample for proteomic analysis DIAGNOSTIC_TEST

Urine sample for proteomic analysis in screen visit (before renal denervation procedure).

Hypertensive patients undergoing renal denervation

ABPM DIAGNOSTIC_TEST

ABPM in screen visit and 3 months after renal denervation procedure.

Hypertensive patients undergoing renal denervation

OBPM DIAGNOSTIC_TEST

OBPM in screen visit and 3 months after renal denervation procedure.

Hypertensive patients undergoing renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective, non-interventional, observational study enrolling a total of 100 patients, with uncontrolled hypertension, aged 18-80 years, submitted to renal denervation. During baseline evaluation hypertension diagnosis will be confirmed by OBP and ABP measurememts, while all patients have to be untreated or treated with maximum of 3 antihypertensive drugs (at least on 50% of maximum dose). Patients with moderate to severe chronic kidney disease (eGFR \<45 ml/min), renal artery abnormalities, type I diabetes mellitus and secondary hypertension will be excluded. The enrolled cases will be followed up in 3 months after renal denervation. Data will be collected using a specific form (CRF).

You may qualify if:

• All treated patients have to be on standard antihypertensive regimens for at least 8 weeks
• Age 18-80 years
• Office systolic blood pressure ≥140 mmHg and
• Ambulatory systolic blood pressure ≥130 mmHg

You may not qualify if:

• eGFR \<45mL/min/1.73m2
• Renal artery abnormalities
• Type I diabetes mellitus
• Secondary hypertension
• Pregnant or breastfeeding women
• Psychiatric or neurological disease which does not allow adequate co-operation
• Active cancer on treatment

Sponsors & Collaborators

• Hippocration General Hospital: lead
• National and Kapodistrian University of Athens: collaborator
• Biomedical Research Foundation, Academy of Athens: collaborator

Study Sites (1)

First Cardiology Clinic, Hippokration General Hospital, National and Kapodistrian University of Athens

Athens, Greece

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Konstantinos P Tsioufis, Professor of Cardiology

CONTACT

2132088099; ktsioufis@hippocratio.gr

Dimitrios S Polyzos, MD

CONTACT

6977535135; dim_polyzos@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: January 17, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

GR (1)