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

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Biological: Infliximab; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02743390

2015171517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

TNF-alpha inhibitor drug

Active Comparator group

Description:

Infliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL)

Treatment:

Biological: Infliximab

Placebo drug

Placebo Comparator group

Description:

Saline infusion (250mL)

Treatment:

Other: Saline