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

NCT ID: NCT02743390

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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blood pressure inflammation tumor Necrosis Factor-alpha

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TNF-alpha inhibitor drug

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

Group Type ACTIVE_COMPARATOR

Infliximab

Intervention Type BIOLOGICAL

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

Placebo drug

Saline infusion (250mL)

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Saline for 2 hours (250mL)

Interventions

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Infliximab

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

Intervention Type BIOLOGICAL

Saline

Saline for 2 hours (250mL)

Intervention Type OTHER

Other Intervention Names

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Tumour necrosis factor alpha (TNF-α) inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Heitor Moreno Junior

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Paula Faria, PhD

Role: STUDY_CHAIR

University of Campinas

Locations

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University of Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2015171517

Identifier Type: -

Identifier Source: org_study_id