Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743390
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Heitor Moreno Junior, 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.

Condition or disease Intervention/treatment Phase
Hypertension Biological: Infliximab Other: Saline Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of the TNF-alpha Inhibiton on Blood Pressure, Hemodynamic Parameters and Biomarkers in Resistant Hypertension
Actual Study Start Date : March 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Active Comparator: TNF-alpha inhibitor drug
Infliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL)
Biological: Infliximab
Monoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL)
Other Name: Tumour necrosis factor alpha (TNF-α) inhibitor

Placebo Comparator: Placebo drug
Saline infusion (250mL)
Other: Saline
Saline for 2 hours (250mL)




Primary Outcome Measures :
  1. Mean blood pressure in mmHg [ Time Frame: 15 minutes ]
    Mean blood pressure will be simultaneously assessed for 15 minutes in baseline, during and post the infusions


Secondary Outcome Measures :
  1. Cardiac hypertrophy in g/m² [ Time Frame: 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

  2. Endothelial function in percentage [ Time Frame: 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

  3. Arterial stiffness in m/s [ Time Frame: 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

  4. Tumor necrosis factor-alpha in pg/mL [ Time Frame: Baseline and post-1 week of the infusions ]
    Plasma concentration of tumor necrosis factor-alpha will be determined by ELISA

  5. Interleukin-6 [ Time Frame: Baseline and post-1 week of the infusions ]
    Plasma concentration of Interleukin-6 will be determined by ELISA

  6. Interleukin-10 [ Time Frame: Baseline and post-1 week of the infusions ]
    Plasma concentration of Interleukin-10 will be determined by ELISA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743390


Locations
Layout table for location information
Brazil
University of Campinas (UNICAMP)
Campinas, São Paulo, Brazil, 13083970
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Layout table for investigator information
Study Chair: Ana Paula Faria, PhD University of Campinas
Layout table for additonal information
Responsible Party: Heitor Moreno Junior, Principal investigator, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02743390    
Other Study ID Numbers: 2015171517
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Heitor Moreno Junior, University of Campinas, Brazil:
blood pressure
inflammation
tumor Necrosis Factor-alpha
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents