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NCT Number: NCT02743390

Effects of the TNF-alpha Inhibiton on Hemodynamic Parameters in Resistant Hypertension

Resistant hypertension (RH) is characterized by high blood pressure (BP) in spite of concurrent use of three or more antihypertensive agents of different classes, combined at optimal doses. Currently it has been largely discussed the influence of inflammation in RH. The BP variation promotes increased expression of pro-inflammatory cytokines, such as tumor necrosis factor-alpha, interleukins 1 and 6. It was showed that treatment with TNF-α inhibitor improves BP and endothelial function, and reduces arterial stiffness in patients with rheumatoid arthritis. Recently, it was demonstrated that TNF-α levels are increased in RH subjects compared to normotensives. This study aims to assess whether the acute inhibition of TNF-α changes hemodynamic parameters, such as mean BP levels in RH.

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Key information

Conditions

Hypertension Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Campinas (UNICAMP)

Campinas, São Paulo, 13083970, Brazil

About this study

This crossover, double-blind study will include 12 resistant hypertensive subjects - regularly followed at the Outpatient Resistant Hypertension Clinic/UNICAMP - which will randomized assigned to (1) saline infusion followed by infliximab infusion (TNF-α inhibitor, 3 mg/kg) and (2) infliximab followed by saline, for two hours and washout of the 40-day period between both infusions. It is expected that the TNF-α inhibition regulates hemodynamic parameters, such as mean BP, cardiac Output, total peripheral resistance, which may allow a better rational approach for the RH treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the diagnosis recommended by the AHA Statment on Resistant Hypertension (2008)
  • a 6-month period clinic follow-up
  • give written informed consent form

Exclusion criteria

  • secondary Hypertension
  • pseudoresistance hypertension (poor medication adherence and white coat hypertension)
  • patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases
  • pregnant women
  • smoking
  • autoimmune diseases

Treatment and study plan

Infliximab

Biological

Monoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL)

Other names: Tumour necrosis factor alpha (TNF-α) inhibitor

Saline

Other

Saline for 2 hours (250mL)

Primary outcomes

  1. Mean blood pressure in mmHg

    Time frame: 15 minutes

    Mean blood pressure will be simultaneously assessed for 15 minutes in baseline, during and post the infusions

Secondary outcomes

  1. Cardiac hypertrophy in g/m²

    Time frame: Baseline and post-1 week of the infusions

    Left ventricular mass index will be determined by echocardiography in baseline and post-1 week of the infusions

  2. Endothelial function in percentage

    Time frame: Baseline and post-1 week of the infusions

    Endothelial function will be assessed by flow-mediated dilation in baseline and post-1 week of the infusions

  3. Arterial stiffness in m/s

    Time frame: Baseline and post-1 week of the infusions

    Arterial stiffness will be determined by pulse wave velocity in baseline and post-1 week of the infusions

  4. Tumor necrosis factor-alpha in pg/mL

    Time frame: Baseline and post-1 week of the infusions

    Plasma concentration of tumor necrosis factor-alpha will be determined by ELISA

  5. Interleukin-6

    Time frame: Baseline and post-1 week of the infusions

    Plasma concentration of Interleukin-6 will be determined by ELISA

  6. Interleukin-10

    Time frame: Baseline and post-1 week of the infusions

    Plasma concentration of Interleukin-10 will be determined by ELISA

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

Effects of the TNF-alpha Inhibiton on Blood Pressure, Hemodynamic Parameters and Biomarkers in Resistant Hypertension

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2016
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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