Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.

The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005464-26-GB

Enrollment

100

Registered

2008-04-11

Start date

2008-06-05

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870

Interventions

Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female subjects over 18 years of age 2. Systemic inflammatory conditions (rheumatoid arthritis) diagnosis established independently by the clinical team 3. Eligiblilty for anti-TNF-alpha therapy- decision to start treatment reached independently by the clinical team. 4.Woman of childbearing potential must have a negative serum pregnancy test within 7 days of the first adminstration of study treatment, and must be willing to use a reliable form of contraception to prevent pregnancy. 5. Provision of signed, informed, consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. Inability to tolerate scanning (claustrophobia, inability to lie flat); 2. Contra-indications to MRI (implantable devices, hypersensitivity to Gadolinium- containing contrast agents, weight over 120kg); 3. Inability to give informed consent; 4. Non-sinus rhythm; 5. Above 70 years of age. 6. Diagnosis of tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections, chronic infection or a history of recurrent infection. 7. Moderate or severe heart failure (NYHA class III/IV) 8. Patients with a history of hypersensitivity to infliximab, entanercept, adalimumab or other murine proteins, or to any of the excipients 9. Concomitant use of immunosuppressive therapy, anakinra, abatacept, sulfasalazine or live vaccinations 10. Patient with a history of Hepatitis B and C virus infection 11. Patients with a history of malignancy 12. Significantly impaired renal function (eGFR >60 ml/min/1.73m2) 13. Significantly impaired hepatic function (alkaline transaminase twice above the upper limit of the normal range) 14. Pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia, thrombocytopenia or anaemia 15. Current pregnancy or lactation. 16. Patients with any significant history of non-compliance to medical regimens. 17. History of asthma, significant bradycardia and arrhythmias 18. Known hypersensitivity to adenosine 19. Known or suspected bronchostrictive or bronchospasti disease 20. Second- or third- degree atrioventricular (AV) block, sinus bradychardia (heart rate <45 bpm) 21. Systemic arterial hypotension (<90mm Hg)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate TNF-alpha inhibitors altering cardiovascular function in patients with systemic inflammatory conditions (FMD, LV mass/LV volumes);Secondary Objective: Atherosclerotic plaque burden, Vascular distensibility and stiffness, Global and regional, systolic and diasystolic function and tissue characterisation, haematological and biochemical indices of vascular inflammation, myocardial microvascular function; Primary end point(s): Primary Outcomes: 1. Aortic distensiblity and stiffness studies (PWV and AD) 2.Myocardial function (LV mass, LV volumes) ;Timepoint(s) of evaluation of this end point: Prior to starting anti-TNF therapy and 3, 6, 18, months afterwards	—

Measure

Time frame

Main Objective: To investigate TNF-alpha inhibitors altering cardiovascular function in patients with systemic inflammatory conditions (FMD, LV mass/LV volumes);Secondary Objective: Atherosclerotic plaque burden, Vascular distensibility and stiffness, Global and regional, systolic and diasystolic function and tissue characterisation, haematological and biochemical indices of vascular inflammation, myocardial microvascular function; Primary end point(s): Primary Outcomes: 1. Aortic distensiblity and stiffness studies (PWV and AD) 2.Myocardial function (LV mass, LV volumes) ;Timepoint(s) of evaluation of this end point: Prior to starting anti-TNF therapy and 3, 6, 18, months afterwards

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes: 1.Atherosclerotic plaque burden 2.Global and regional, systolic and diastolic function and tissue characterisation 3.Myocardial microvascular function (coronary flow reserve) ;Timepoint(s) of evaluation of this end point: Prior to starting anti-TMF therapy and 3, 6, 18, months afterwards	—

Countries

United Kingdom

Contacts

Public ContactDr Valentina Puntmann

Kings College London

v.puntmann@kcl.ac.uk00440207188 7242

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026