|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03667131 |
|
Date of registration:
|
10/09/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.
|
|
Scientific title:
|
Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients. |
|
Date of first enrolment:
|
February 13, 2017 |
|
Target sample size:
|
59 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03667131 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Monica Vázquez-Del Mercado, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Guadalajara |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients classified with RA according to the American College of Rheumatology (ACR) /
European League Against Rheumatism (EULAR) 2010
- Patients treated in the outpatient service of the Rheumatology Service of the Hospital
Civil de Guadalajara "Dr. Juan I Menchaca".
- Sign an Informed Consent Letter
- Under treatment with conventional Disease-Modifying Antirheumatic Drugs (DMARDS)
Exclusion Criteria:
- Patients with a previous diagnosis of diabetes mellitus, systemic hypertension,
thyroid, kidney or liver disease
- History of acute myocardial infarction, cardiac arrhythmias, cerebral vascular event
or heart failure
- Smoking active patients in the last 6 months
- Patients with a desire for close conception, pregnant or breastfeeding.
- Patients with blood pressure <90/60 mmHg
- Patients who do not accept to participate in the study
- Patients with a BMI greater than =40 Kg / m2
- Non-palpable carotid and femoral pulses
- Unstable psychological state
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: Enalapril Maleate
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Change in Pulse Wave Velocity (PWV)
[Time Frame: Baseline and 90 days]
|
|
Secondary Outcome(s)
|
|
Change in Cardio-Ankle Vascular Index
[Time Frame: Baseline and 90 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|