Heart FailureRA-HFNCT03960515
Cardiovascular Profiles in Rheumatoid Arthritis
An observational study of Heart Failure and Cardiovascular Risk Factor, run by Maria Betânia Almeida Dias Ferreira.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiovascular Risk Factor, Rheumatoid Arthritis
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2016to 7 May 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients with diagnosis of Rheumatoid Arthritis.
Who may be able to join
- 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
Who cannot join
- Presence of severe life-threatening disease before inclusion with an expected survival of less than 6 months after inclusion
- Mental or physical status not allowing written informed consent
- Active malignancy disease
- Patient unable to walk, in which SMWT is not possible to perform.
About this study
Official title: Cardiovascular Risk, Myocardial Fibrosis and Heart Failure in Rheumatoid Arthritis: Screening and Prognosis
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.
Read more
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
Read the detailed description
Patient Selection:
Screen ~400 Rheumatoid Arthritis (RA) patients followed in Centro Hospitalar do Porto outpatient clinic. All RA patients with regular follow-up will be potentially included.
The investigators also aim to enrol age-matched controls for biomarker comparison.
Experimental Design:
Observacional study with matched control. No intervention will be performed. Outpatients fulfilling the inclusion criteria will be invited to participate in the study. All patients will have to sign written informed consent to participate in the study.
An external and independent data verification will be performed. The total trial enrolment period was 23 months. . Participants will continue to receive treatments as clinically indicated and according to the decision of their attending physicians.
A structured evaluation will be performed. Every 4 to 6 months the participants will be observed in the clinic for their physicians according clinic protocol. The participants will not require additional visits to the hospital other than the visits already prespecified by their attending physicians.
Clinical Evaluation:The clinical evaluation will be performed to all RA patients and for age-matched controls Each participant and group control will be evaluated for their cardiovascular symptoms, history and risk factors for cardiovascular disease, other comorbiditys as renal disease, dementia, liver or respiratory disease or anemia. The participants will be evaluated for their Rheumathoid Arthritis history (diagnosis date, rx erosion, other autoimune diseases or treatment). All will perform a 6-minute walk test (6MWT), point blood pressure, heart rate, chest exam, ankle-brachial index, measurement of abdominal circumference and visceral fat, disease activity score 28 (DAS-28), quality of life scores (QoL), Graffar scale (socio-economic), Mini-cog and Epworth scale.
Cardiac Function: Each participant will undergo a 12 lead ECG and a transthoracic echocardiography. M-mode, 2D and Doppler measurements will be acquired according to standard recommendations. LV mass and LV mass index, left atrial (LA) volume, LA volume index, isovolumetric relaxation time (IVRT), mitral inflow E to A ratio (mitral E/A), mitral deceleration time of early filling (mitral DT), PW Doppler early diastolic velocity of the septal (septal e') and lateral (lateral e') mitral annulus, mitral inflow E velocity to early diastolic tissue Doppler of both the septal (septal E/e') and lateral (lateral E/e') mitral annulus and the pulmonary artery systolic pressure (PASP) will be measured using standard techniques19. All measurements reflect an average of at least 4 consecutive cardiac cycles and will be performed by an experienced echocardiographer.
Regular Plasma and Urine Biomarkers:For all participants. Regular blood biomarkers: hemoglobin, hematocrit, RDW, Thrombocytes, Leucocytes, lymphocytes, neutrophils, NT-proBNP , Troponin I, C-reactive Protein, Alkaline phosphatase, Ƴ-GT, Sedimentation rate, Glucose, Total Cholesterol, Triglycerides, LDL-Cholesterol,HDL- Cholesterol, Transferrin saturation, Ferritin, HbA1c, Pre-albumin, C-Cistatin, homocystein, Sodium , Potassium, Chlorine, Calcium, Phosphorus, Magnesium, Creatinine, Urea, Folic Acid, Cianocobalamin, PTH, eGFR, D Vitamin, Uric Acid.
Urine biomarkers: Microalbumin, Creatinine, Potassium, Sodium.
Specific biomarkers: For all RA patients and control group. Include OLINK's panels for inflammation, fibrosis or matrix extracellular organization.
- Conditions
- Heart Failure, Cardiovascular Risk Factor, Rheumatoid Arthritis, Myocardium; Injury, Cardiovascular Diseases
- Keywords
- Rheumatoid Arthritis, Heart disease, Cardiovascular Risk
- Medical subject headings
- Heart Failure, Arthritis, Rheumatoid, Wounds and Injuries, Cardiovascular Diseases, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dead participants
Death of any cause
Measured: 11 to 32 months
Number of Participants with New diagnosis of heart failure
New onset of heart failure symptons with diuretic drugs starting
Measured: 11 to 32 months
Secondary outcomes (5)
Number of Participants with worsening of previous heart failure
Worsening of heart failure with increase of diuretic or diuretic IV
Measured: 11 to 32 months
Number of Participants with new onset atrial fibrillation
New onset of Atrial Fibrillation
Measured: 11 to 32 months
Number of Participants with Hospitalization
Any hospitalization for urgent or unplanned reasons
Measured: 11 to 32 months
Number of Participants with new onset of stroke or Transient ischemic attack
New onset of stroke or transient ischemic attack
Measured: 11 to 32 months
Number of Participants with New onset of acute myocardial infarction
New onset of acute myocardial infarction?
Measured: 11-32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start22 Jun 2016
- Primary completion5 Apr 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Betânia Almeida Dias Ferreira
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas Abel Salazar, Central Hospital, Nancy, France, Unit Multidisciplinary Research in Biomedicine
- Responsible party
- Sponsor-investigator, Maria Betânia Almeida Dias Ferreira, Centro Hospitalar do Porto
- Investigators
- António J. Marinho, MD, PhD, Study chair, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960515
- Sponsor's protocol ID
- 2016-023 (020-DEFI/020-CES)
- Acronym
- RA-HF
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.
PubMed 23327517Choy 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.
PubMed 24907149Kawai 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.
PubMed 25371313Agca 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.
PubMed 27697765Solomon 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.
PubMed 12628952Arts 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.
PubMed 24389293Ferreira 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.
PubMed 35429115Ferreira 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.
PubMed 33162300
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk, Myocardial Fibrosis and Heart Failure in Rheumatoid Arthritis: Screening and Prognosis
- ClinicalTrials.gov ID
- NCT03960515
- Acronym / sponsor ID
- RA-HF / 2016-023 (020-DEFI/020-CES)
- Conditions
- Heart Failure, Cardiovascular Risk Factor, Rheumatoid Arthritis, Myocardium; Injury, Cardiovascular Diseases
- Keywords
- Rheumatoid Arthritis, Heart disease, Cardiovascular Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Maria Betânia Almeida Dias FerreiraUniversity, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas Abel Salazar, Central Hospital, Nancy, France, Unit Multidisciplinary Research in Biomedicine
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 23 May 2019 (actual)
- 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.
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
Detailed description
Patient Selection:
Screen ~400 Rheumatoid Arthritis (RA) patients followed in Centro Hospitalar do Porto outpatient clinic. All RA patients with regular follow-up will be potentially included.
The investigators also aim to enrol age-matched controls for biomarker comparison.
Experimental Design:
Observacional study with matched control. No intervention will be performed. Outpatients fulfilling the inclusion criteria will be invited to participate in the study. All patients will have to sign written informed consent to participate in the study.
An external and independent data verification will be performed. The total trial enrolment period was 23 months. . Participants will continue to receive treatments as clinically indicated and according to the decision of their attending physicians.
A structured evaluation will be performed. Every 4 to 6 months the participants will be observed in the clinic for their physicians according clinic protocol. The participants will not require additional visits to the hospital other than the visits already prespecified by their attending physicians.
Clinical Evaluation:The clinical evaluation will be performed to all RA patients and for age-matched controls Each participant and group control will be evaluated for their cardiovascular symptoms, history and risk factors for cardiovascular disease, other comorbiditys as renal disease, dementia, liver or respiratory disease or anemia. The participants will be evaluated for their Rheumathoid Arthritis history (diagnosis date, rx erosion, other autoimune diseases or treatment). All will perform a 6-minute walk test (6MWT), point blood pressure, heart rate, chest exam, ankle-brachial index, measurement of abdominal circumference and visceral fat, disease activity score 28 (DAS-28), quality of life scores (QoL), Graffar scale (socio-economic), Mini-cog and Epworth scale.
Cardiac Function: Each participant will undergo a 12 lead ECG and a transthoracic echocardiography. M-mode, 2D and Doppler measurements will be acquired according to standard recommendations. LV mass and LV mass index, left atrial (LA) volume, LA volume index, isovolumetric relaxation time (IVRT), mitral inflow E to A ratio (mitral E/A), mitral deceleration time of early filling (mitral DT), PW Doppler early diastolic velocity of the septal (septal e') and lateral (lateral e') mitral annulus, mitral inflow E velocity to early diastolic tissue Doppler of both the septal (septal E/e') and lateral (lateral E/e') mitral annulus and the pulmonary artery systolic pressure (PASP) will be measured using standard techniques19. All measurements reflect an average of at least 4 consecutive cardiac cycles and will be performed by an experienced echocardiographer.
Regular Plasma and Urine Biomarkers:For all participants. Regular blood biomarkers: hemoglobin, hematocrit, RDW, Thrombocytes, Leucocytes, lymphocytes, neutrophils, NT-proBNP , Troponin I, C-reactive Protein, Alkaline phosphatase, Ƴ-GT, Sedimentation rate, Glucose, Total Cholesterol, Triglycerides, LDL-Cholesterol,HDL- Cholesterol, Transferrin saturation, Ferritin, HbA1c, Pre-albumin, C-Cistatin, homocystein, Sodium , Potassium, Chlorine, Calcium, Phosphorus, Magnesium, Creatinine, Urea, Folic Acid, Cianocobalamin, PTH, eGFR, D Vitamin, Uric Acid.
Urine biomarkers: Microalbumin, Creatinine, Potassium, Sodium.
Specific biomarkers: For all RA patients and control group. Include OLINK's panels for inflammation, fibrosis or matrix extracellular organization.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients with diagnosis of Rheumatoid Arthritis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of severe life-threatening disease before inclusion with an expected survival of less than 6 months after inclusion
- Mental or physical status not allowing written informed consent
- Active malignancy disease
- Patient unable to walk, in which SMWT is not possible to perform.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of dead participants
Time frame: 11 to 32 months
Death of any cause
Number of Participants with New diagnosis of heart failure
Time frame: 11 to 32 months
New onset of heart failure symptons with diuretic drugs starting
5 secondary outcomes
Number of Participants with worsening of previous heart failure
Time frame: 11 to 32 months
Number of Participants with new onset atrial fibrillation
Time frame: 11 to 32 months
Number of Participants with Hospitalization
Time frame: 11 to 32 months
Number of Participants with new onset of stroke or Transient ischemic attack
Time frame: 11 to 32 months
Number of Participants with New onset of acute myocardial infarction
Time frame: 11-32 months
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 24 May 2019.
- Background: PubMed 23327517Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.
- Background: PubMed 24907149Choy 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.
- Background: PubMed 25371313Kawai 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.
- Background: PubMed 27697765Agca 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.
- Background: PubMed 12628952Solomon 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.
- Background: PubMed 24389293Arts 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.
- Derived from this study: PubMed 35429115Ferreira 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.
- Derived from this study: PubMed 33162300Ferreira 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.
- Individual participant dataSharing planned: No
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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.
António J. Marinho, MD, PhD study chair
Centro Hospitalar do Porto
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiovascular Risk Factor, run by Maria Betânia Almeida Dias Ferreira.
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 4 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 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Number of dead participants (time frame: 11 to 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960515, which also lists 8 linked publications.
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 24 May 2019.