The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone.

NCT06208072 | Unknown

• 1 other identifier: PREDICT-HTN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the available means of treating primary arterial hypertension, the prevalence of hypertensive patients with inadequately controlled blood pressure levels, remains high. The identification of biomarkers with prognostic and predictive roles seems to play an important role in the management of hypertensive patients. Proteomic analysis studies provide encouraging results in the identification of such biomarkers. The goal of this clinical study is to is to highlight peptides through urinary proteomic analysis of obese hypertensive patients, capable of predicting blood pressure response, following treatment with irbesartan or eplerenone.

Conditions

Primary Hypertension; Obesity

Keywords

Hypertension; Obesity; Urinary Proteomics; Proteomic Analysis; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Urinary peptide differential expression between responders and non-responders, in patients treated with Irbesartan

  Utilizing liquid chromatography with tandem mass spectrometry (LC/MS-MS) the relative difference in protein abundance between responders and non-responders will be measured, expressed in fold change. Peptides with statistically significant differential expression between the two groups, may be used as urinary biomarkers for blood pressure response.

  8 weeks

• Urinary peptide differential expression between responders and non-responders, in patients treated with Eplerenone

  Utilizing LC/MS-MS, the relative difference in protein abundance between responders and non-responders will be measured, expressed in fold change. Peptides with statistically significant differential expression between the two groups, may be used as urinary biomarkers for blood pressure response.

  8 weeks

Study Arms (2)

Irbesartan group

ACTIVE COMPARATOR

Randomized obese hypertensive patients will receive treatment with oral Irbesartan 150mg once daily for 8 weeks. Blood pressure response will be assessed at that time.

Drug: Irbesartan 150mg

Eplerenone group

ACTIVE COMPARATOR

Randomized obese hypertensive patients will receive treatment with oral Eplerenone twice daily for 8 weeks. Blood pressure response will be assessed at that time.

Drug: Eplerenone 25 mg

Interventions

Irbesartan 150mg DRUG

Irbesartan group will be treated with Irbesartan 150mg once daily for a total of 8 weeks.

Also known as: I

Irbesartan group

Eplerenone 25 mg DRUG

Eplerenone group will be treated with Eplerenone 25mg twice daily for a total of 8 weeks

Also known as: E

Eplerenone group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic office blood pressure 140-179mmHg and/or diastolic office blood pressure 90-119mmHg
• Mean systolic 24h ABPM \>130mmHg and/or mean diastolic ABPM \>80mmHg
• Obese patient with BMI 30-39.99kg/m2
• Signed informed consent

You may not qualify if:

• Participation in an Investigational Medicinal Product (IMP) or invasive device clinical trial during the study or in the last 6 months
• Patient with secondary arterial hypertension
• Patient with a history within 6 months of: Myocardial infarction, Unstable angina, Stroke
• Patient with type 1 diabetes
• Patient with systolic heart failure EF≤40%
• Patient with chronic kidney disease (eGFR\<45mL/min/1.73m2)
• Patient with bilateral renal artery stenosis
• Patient with hyperkalemia (\>5.5 mEq/L)
• Patient with hemodynamically significant valvular heart disease
• Patient with Addison's disease
• Female patient in pregnancy or caesarean section or female patient planning pregnancy.
• Planned surgery or cardiovascular surgery in the next 6 months
• Patient with absolute contraindication to any EDPS
• Patient who needs to receive study medication for a different reason
• Patient with neoplasia undergoing treatment (radiotherapy, chemotherapy, immunotherapy)

Sponsors & Collaborators

• Hippocration General Hospital: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Hypertension Unit, A' University Cardiology Clinic, Hippocration General Hospital of Athens

Athens, 115 27, Greece

RECRUITING

Related Publications (9)

• Kitt J, Fox R, Tucker KL, McManus RJ. New Approaches in Hypertension Management: a Review of Current and Developing Technologies and Their Potential Impact on Hypertension Care. Curr Hypertens Rep. 2019 Apr 25;21(6):44. doi: 10.1007/s11906-019-0949-4.

  PMID: 31025117 BACKGROUND

• Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020 Apr;16(4):223-237. doi: 10.1038/s41581-019-0244-2. Epub 2020 Feb 5.

  PMID: 32024986 BACKGROUND

• Manolis AJ, Poulimenos LE, Kallistratos MS, Gavras I, Gavras H. Sympathetic overactivity in hypertension and cardiovascular disease. Curr Vasc Pharmacol. 2014 Jan;12(1):4-15. doi: 10.2174/15701611113119990140.

  PMID: 23905597 BACKGROUND

• Tsioufis C, Kordalis A, Flessas D, Anastasopoulos I, Tsiachris D, Papademetriou V, Stefanadis C. Pathophysiology of resistant hypertension: the role of sympathetic nervous system. Int J Hypertens. 2011 Jan 20;2011:642416. doi: 10.4061/2011/642416.

  PMID: 21331155 BACKGROUND

• Navajas R, Corrales F, Paradela A. Quantitative proteomics-based analyses performed on pre-eclampsia samples in the 2004-2020 period: a systematic review. Clin Proteomics. 2021 Jan 26;18(1):6. doi: 10.1186/s12014-021-09313-1.

  PMID: 33499801 BACKGROUND

• Martin-Lorenzo M, Martinez PJ, Baldan-Martin M, Lopez JA, Minguez P, Santiago-Hernandez A, Vazquez J, Segura J, Ruiz-Hurtado G, Vivanco F, Barderas MG, Ruilope LM, Alvarez-Llamas G. Urine Haptoglobin and Haptoglobin-Related Protein Predict Response to Spironolactone in Patients With Resistant Hypertension. Hypertension. 2019 Apr;73(4):794-802. doi: 10.1161/HYPERTENSIONAHA.118.12242.

  PMID: 30712426 BACKGROUND

• Correa Rojo A, Heylen D, Aerts J, Thas O, Hooyberghs J, Ertaylan G, Valkenborg D. Towards Building a Quantitative Proteomics Toolbox in Precision Medicine: A Mini-Review. Front Physiol. 2021 Aug 26;12:723510. doi: 10.3389/fphys.2021.723510. eCollection 2021.

  PMID: 34512391 BACKGROUND

• Alharbi RA. Proteomics approach and techniques in identification of reliable biomarkers for diseases. Saudi J Biol Sci. 2020 Mar;27(3):968-974. doi: 10.1016/j.sjbs.2020.01.020. Epub 2020 Jan 27.

  PMID: 32127776 BACKGROUND

• Schessner JP, Voytik E, Bludau I. A practical guide to interpreting and generating bottom-up proteomics data visualizations. Proteomics. 2022 Apr;22(8):e2100103. doi: 10.1002/pmic.202100103. Epub 2022 Feb 15.

  PMID: 35107884 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension; Obesity; Hypertension

Interventions

Irbesartan; Eplerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Konstantinos P Tsioufis, Prof

  First University Cardiology Clinic, Hippocration General Hospital of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos P Tsioufis, Prof

CONTACT

6932586087; ktsioufis@hippocratio.gr

Sotirios Drogkaris, MD, MsC

CONTACT

6942203728; dsotiris@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Cardiology

Model Details: Enrolled patients will be randomized into two arms. One arm will receive treatment with Irbesartan 150mg once daily and the second arm will receive treatment with Eplerenone 25mg twice daily. Blood pressure response will be assessed after 8 weeks. For both arms peptide differences will be assessed through proteomic analysis in responders and non responders in each individual arm.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)