Effects of the TNF-alpha Inhibiton on Hemodynamic Parameters in Resistant Hypertension
- Conditions
- Hypertension
- Interventions
- Biological: InfliximabOther: Saline
- Registration Number
- NCT02743390
- Lead Sponsor
- University of Campinas, Brazil
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- the diagnosis recommended by the AHA Statment on Resistant Hypertension (2008)
- a 6-month period clinic follow-up
- give written informed consent form
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TNF-alpha inhibitor drug Infliximab Infliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL) Placebo drug Saline Saline infusion (250mL)
- Primary Outcome Measures
Name Time Method Mean blood pressure in mmHg 15 minutes Mean blood pressure will be simultaneously assessed for 15 minutes in baseline, during and post the infusions
- Secondary Outcome Measures
Name Time Method Cardiac hypertrophy in g/m² 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
Endothelial function in percentage 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
Arterial stiffness in m/s 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
Tumor necrosis factor-alpha in pg/mL Baseline and post-1 week of the infusions Plasma concentration of tumor necrosis factor-alpha will be determined by ELISA
Interleukin-6 Baseline and post-1 week of the infusions Plasma concentration of Interleukin-6 will be determined by ELISA
Interleukin-10 Baseline and post-1 week of the infusions Plasma concentration of Interleukin-10 will be determined by ELISA
Trial Locations
- Locations (1)
University of Campinas (UNICAMP)
🇧🇷Campinas, São Paulo, Brazil