The effect of TNF blocking therapy on cardiac function in patients with active rheumatoid arthritis

The effect of TNF blocking therapy on cardiac function in patients with active rheumatoid arthritis - Effect of biologicals on cardiac function in active RA patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44306

Enrollment

Registered

2014-07-14

Start date

2014-12-11

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

heart disease Rheumatoid arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis rheumatoid arthritis Written informed consent Active disease (DAS28>=3.2) and/or C-reactive protein >10 mg/l and/or Erythrocyte Sedimentation Rate (ESR) > 15 mm/h

Exclusion criteria

Exclusion criteria: Medical history of cardiac disease (i.e. myocardial infarction, heart failure etc) Use of TNF blocking therapy 3 months prior to start study

Design outcomes

Primary

Measure	Time frame
The primary outcome is diastolic LV dysfunction, defined as follows: mild diastolic LV dysfunction (stage Iimpaired relaxation). Characterized by an E/A ratio 240 ms), and IVRT (>110 ms). Em (1, Em/Am 10. Severe diastolic LV dysfunction (stage III restrictive filling). This stage is characterized by an overt increased E/A ratio (>2), shortened DT (10.	—

Secondary

Measure	Time frame
Secondary outcomes: Systolic LV dysfunction will be defined as an ejection fraction of 0.20 seconds, QRS duration	—

Countries

Netherlands

Outcome results