A Phase 4 interventional study of Infliximab and Saline in Hypertension, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-09.
Sponsored by University of Campinas, Brazil · Phase 4, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL)
Biological: Infliximab
Saline infusion (250mL)
Other: Saline
Monoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL)
Also known as: Tumour necrosis factor alpha (TNF-α) inhibitor
Saline for 2 hours (250mL)
Mean blood pressure in mmHg
Mean blood pressure will be simultaneously assessed for 15 minutes in baseline, during and post the infusions
Time frame: 15 minutes
Cardiac hypertrophy in g/m²
Left ventricular mass index will be determined by echocardiography in baseline and post-1 week of the infusions
Time frame: Baseline and post-1 week of the infusions
Endothelial function in percentage
Endothelial function will be assessed by flow-mediated dilation in baseline and post-1 week of the infusions
Time frame: Baseline and post-1 week of the infusions
Arterial stiffness in m/s
Arterial stiffness will be determined by pulse wave velocity in baseline and post-1 week of the infusions
Time frame: Baseline and post-1 week of the infusions
Tumor necrosis factor-alpha in pg/mL
Plasma concentration of tumor necrosis factor-alpha will be determined by ELISA
Time frame: Baseline and post-1 week of the infusions
Interleukin-6
Plasma concentration of Interleukin-6 will be determined by ELISA
Time frame: Baseline and post-1 week of the infusions
Interleukin-10
Plasma concentration of Interleukin-10 will be determined by ELISA
Time frame: Baseline and post-1 week of the infusions
Plan to share: Undecided
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil