NCT03960515

Brief Summary

Cardiovascular disease is the leading cause of death in RA patients. This increased risk may be apparent even before the clinical recognition of RA. The optimal approach for identification of patients with increased CV risk has yet to be fully established and a substantial proportion of RA patients at high risk remain unidentified. Heart failure (HF) has been recently recognized as an important contributory factor to the excess CV mortality associated with RA (more than myocardial ischemia), and RA patients with concomitant HF have twice the risk of CV death compared with patients with RA alone. HF in RA typically presents with occult or atypical clinical symptomatology, tend to be managed less aggressively and have poorer outcomes. For developing effective preventive strategies, the evaluation of patients in early asymptomatic stages is of great importance. The investigators propose to perform an observational longitudinal study (with cases and controls) including RA patients (with and without HF) from a single centre to determine cardiovascular profiles that may be associated with higher risk for developing symptomatic HF and CV events. For this purpose the investigators will use clinical, echocardiographic, serum biomarker, and genetic data

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

May 21, 2019

Last Update Submit

May 22, 2019

Conditions

Heart FailureCardiovascular Risk FactorRheumatoid ArthritisMyocardium; InjuryCardiovascular Diseases

Keywords

Rheumatoid ArthritisHeart diseaseCardiovascular Risk

Outcome Measures

Primary Outcomes (2)

  • Number of dead participants

    Death of any cause

    11 to 32 months

  • Number of Participants with New diagnosis of heart failure

    New onset of heart failure symptons with diuretic drugs starting

    11 to 32 months

Secondary Outcomes (5)

  • Number of Participants with worsening of previous heart failure

    11 to 32 months

  • Number of Participants with new onset atrial fibrillation

    11 to 32 months

  • Number of Participants with Hospitalization

    11 to 32 months

  • Number of Participants with new onset of stroke or Transient ischemic attack

    11 to 32 months

  • Number of Participants with New onset of acute myocardial infarction

    11-32 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults patients with diagnosis of Rheumatoid Arthritis.

You may qualify if:

  • Diagnosis of Rheumatoid arthritis
  • Regular follow up on Autoimmune diseases medical appointment
  • Written informed consent to participate in this study prior to any study procedures

You may not qualify if:

  • Mental or physical status not allowing written informed consent
  • Active malignancy disease
  • Patient unable to walk, in which SMWT is not possible to perform.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.

    PMID: 23327517BACKGROUND

  • Choy E, Ganeshalingam K, Semb AG, Szekanecz Z, Nurmohamed M. Cardiovascular risk in rheumatoid arthritis: recent advances in the understanding of the pivotal role of inflammation, risk predictors and the impact of treatment. Rheumatology (Oxford). 2014 Dec;53(12):2143-54. doi: 10.1093/rheumatology/keu224. Epub 2014 Jun 6.

    PMID: 24907149BACKGROUND

  • Kawai VK, Chung CP, Solus JF, Oeser A, Raggi P, Stein CM. The ability of the 2013 American College of Cardiology/American Heart Association cardiovascular risk score to identify rheumatoid arthritis patients with high coronary artery calcification scores. Arthritis Rheumatol. 2015 Feb;67(2):381-5. doi: 10.1002/art.38944.

    PMID: 25371313BACKGROUND

  • Agca R, Heslinga SC, Rollefstad S, Heslinga M, McInnes IB, Peters MJ, Kvien TK, Dougados M, Radner H, Atzeni F, Primdahl J, Sodergren A, Wallberg Jonsson S, van Rompay J, Zabalan C, Pedersen TR, Jacobsson L, de Vlam K, Gonzalez-Gay MA, Semb AG, Kitas GD, Smulders YM, Szekanecz Z, Sattar N, Symmons DP, Nurmohamed MT. EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis. 2017 Jan;76(1):17-28. doi: 10.1136/annrheumdis-2016-209775. Epub 2016 Oct 3.

    PMID: 27697765BACKGROUND

  • Solomon DH, Karlson EW, Rimm EB, Cannuscio CC, Mandl LA, Manson JE, Stampfer MJ, Curhan GC. Cardiovascular morbidity and mortality in women diagnosed with rheumatoid arthritis. Circulation. 2003 Mar 11;107(9):1303-7. doi: 10.1161/01.cir.0000054612.26458.b2.

    PMID: 12628952BACKGROUND

  • Arts EE, Popa C, Den Broeder AA, Semb AG, Toms T, Kitas GD, van Riel PL, Fransen J. Performance of four current risk algorithms in predicting cardiovascular events in patients with early rheumatoid arthritis. Ann Rheum Dis. 2015 Apr;74(4):668-74. doi: 10.1136/annrheumdis-2013-204024. Epub 2014 Jan 3.

    PMID: 24389293BACKGROUND

  • Ferreira MB, Fonseca T, Costa R, Marinho A, Oliveira JC, Zannad F, Rossignol P, Rodrigues P, Barros AS, Ferreira JP. Sex differences in circulating proteins of patients with rheumatoid arthritis: A cohort study. Int J Rheum Dis. 2022 Jun;25(6):669-677. doi: 10.1111/1756-185X.14323. Epub 2022 Apr 15.

    PMID: 35429115DERIVED

  • Ferreira MB, Fonseca T, Costa R, Marinhoc A, Carvalho HC, Oliveira JC, Zannad F, Rossignol P, Gottenberg JE, Saraiva FA, Rodrigues P, Barros AS, Ferreira JP. Prevalence, risk factors and proteomic bioprofiles associated with heart failure in rheumatoid arthritis: The RA-HF study. Eur J Intern Med. 2021 Mar;85:41-49. doi: 10.1016/j.ejim.2020.11.002. Epub 2020 Nov 6.

    PMID: 33162300DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and plasma

MeSH Terms

Conditions

Heart FailureArthritis, RheumatoidWounds and InjuriesCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • António J. Marinho, MD, PhD

    Centro Hospitalar do Porto

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Internal Medicine Medical Doctor, PhD student

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

June 22, 2016

Primary Completion

April 5, 2019

Study Completion

May 7, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share