HypertensionPhase 4NCT02743390
Effects of the TNF-alpha Inhibiton on Hemodynamic Parameters in Resistant Hypertension
A Phase 4 study testing Infliximab and Saline in people with Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Infliximab and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the diagnosis recommended by the AHA Statment on Resistant Hypertension (2008)
- a 6-month period clinic follow-up
- give written informed consent form
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the TNF-alpha Inhibiton on Blood Pressure, Hemodynamic Parameters and Biomarkers in Resistant Hypertension
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Infliximab, Saline
- Keywords
- blood pressure, inflammation, tumor Necrosis Factor-alpha
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Also called Tumour necrosis factor alpha (TNF-α) inhibitor
Monoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL)
SalineOther
Saline for 2 hours (250mL)
| Study group | Role | What they receive |
|---|---|---|
| TNF-alpha inhibitor drug | Active comparator | Infliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL) Receives: Biological: Infliximab |
| Placebo drug | Placebo comparator | Saline infusion (250mL) Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure in mmHg
Mean blood pressure will be simultaneously assessed for 15 minutes in baseline, during and post the infusions
Measured: 15 minutes
Secondary outcomes (6)
Cardiac hypertrophy in g/m²
Left ventricular mass index will be determined by echocardiography in baseline and post-1 week of the infusions
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and post-1 week of the infusions
Interleukin-6
Plasma concentration of Interleukin-6 will be determined by ELISA
Measured: Baseline and post-1 week of the infusions
Interleukin-10
Plasma concentration of Interleukin-10 will be determined by ELISA
Measured: Baseline and post-1 week of the infusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heitor Moreno Junior, University of Campinas, Brazil
- Investigators
- Ana Paula Faria, PhD, Study chair, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743390
- Sponsor's protocol ID
- 2015171517
- Status last verified
- Nov 2017
- First submitted
- 5 Apr 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the TNF-alpha Inhibiton on Blood Pressure, Hemodynamic Parameters and Biomarkers in Resistant Hypertension
- ClinicalTrials.gov ID
- NCT02743390
- Acronym / sponsor ID
- 2015171517
- Conditions
- Hypertension
- Keywords
- blood pressure, inflammation, tumor Necrosis Factor-alpha
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNF-alpha inhibitor drug | Active comparator | Biological: InfliximabInfliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL) |
| Placebo drug | Placebo comparator | Other: SalineSaline infusion (250mL) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the diagnosis recommended by the AHA Statment on Resistant Hypertension (2008)
- a 6-month period clinic follow-up
- give written informed consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: Tumour necrosis factor alpha (TNF-α) inhibitorMonoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL) | Biological | TNF-alpha inhibitor drug |
| SalineSaline for 2 hours (250mL) | Other | Placebo drug |
Primary outcome
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
6 secondary outcomes
Cardiac hypertrophy in g/m²
Time frame: Baseline and post-1 week of the infusions
Endothelial function in percentage
Time frame: Baseline and post-1 week of the infusions
Arterial stiffness in m/s
Time frame: Baseline and post-1 week of the infusions
Tumor necrosis factor-alpha in pg/mL
Time frame: Baseline and post-1 week of the infusions
Interleukin-6
Time frame: Baseline and post-1 week of the infusions
Interleukin-10
Time frame: Baseline and post-1 week of the infusions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Paula Faria, PhD study chair
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and Saline in people with Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood pressure in mmHg (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.