NCT02743390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Mar 2015

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

April 5, 2016

Last Update Submit

November 7, 2017

Conditions

Hypertension

Keywords

blood pressureinflammationtumor Necrosis Factor-alpha

Outcome Measures

Primary Outcomes (1)

  • Mean blood pressure in mmHg

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

    15 minutes

Secondary Outcomes (6)

  • Cardiac hypertrophy in g/m²

    Baseline and post-1 week of the infusions

  • Endothelial function in percentage

    Baseline and post-1 week of the infusions

  • Arterial stiffness in m/s

    Baseline and post-1 week of the infusions

  • Tumor necrosis factor-alpha in pg/mL

    Baseline and post-1 week of the infusions

  • Interleukin-6

    Baseline and post-1 week of the infusions

  • +1 more secondary outcomes

Study Arms (2)

TNF-alpha inhibitor drug

ACTIVE COMPARATOR

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

Biological: Infliximab

Placebo drug

PLACEBO COMPARATOR

Saline infusion (250mL)

Other: Saline

Interventions

InfliximabBIOLOGICAL

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
TNF-alpha inhibitor drug
SalineOTHER

Saline for 2 hours (250mL)

Placebo drug

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas (UNICAMP)

Campinas, São Paulo, 13083970, Brazil

Location

MeSH Terms

Conditions

HypertensionInflammation

Interventions

InfliximabTumor Necrosis FactorsSodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ana Paula Faria, PhD

    University of Campinas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 19, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

BR(1)