AnemiaNCT01033175
The Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
A study testing maximal cardiopulmonary exercise testing and peripheral blood samples in people with Anemia and COPD, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
Hypothesis: The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- What is being tested?
- maximal cardiopulmonary exercise testing and peripheral blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGreece
- Study dates
- Dec 2009to Jun 2010
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1st part of the study:
- COPD clinically stable (patients with post-bronchodilation FEV1/FVC <0.7 and no acute exacerbations, hospital admissions or treatment changes in the last 3 months).
- 2nd and 3rd part:
- As above.
Who cannot join
- 1st part of the study:
- history of asthma,
- history of respiratory infection in the last 3 months
- 2nd and 3rd part: As above and additionally:
- history of malignancy or haematologic disorder
- acute or chronic inflammatory disease
Show all 32Show fewer
- systematic or autoimmune disorder
- thyroid disease
- liver cirrhosis
- heart failure (ejection fraction <55%)
- history of gastrointestinal or other hemorrhage
- renal failure (GFR<60 ml/min/1.73m2)
- blood transfusion in the last 4 months
- administration of cortisone in the last month
- pregnancy
- mental impairment
- medical conditions which are contraindications to exercise testing, such as:
- acute myocardial infarction (in the last 6 months)
- unstable angina
- left main coronary stenosis or its equivalent
- syncope
- symptomatic severe aortic stenosis or other moderate stenotic valvular disease
- uncontrolled arrhythmias causing symptoms
- acute pulmonary embolus or pulmonary infarction
- thrombosis of lower extremities
- suspected dissecting aneurysm
- pulmonary oedema
- room air desaturation at rest <85%
- severe untreated arterial hypertension at rest (>200 mmHg systolic, >120 mmHg diastolic)
- high degree atrioventricular block
- hypertrophic cardiomyopathy and
- orthopedic impairment that compromises exercise performance
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Department of Pulmonology, Aristotle University of Thessaloniki
Thessaloniki, 57010
Respiratory Failure Unit, General Hospital "G. Papanikolaou"
Thessaloniki, 57010
About this study
Official title: The Clinical Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
Hypothesis:
The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. exercise capacity does not differ between COPD patients with and without ACD.
Read more
Rationale-Aim:
ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory diseases. COPD is a disorder very likely to be associated to ACD due to its systemic inflammatory dimension. Currently, data on the prevalence of ACD and on the level of inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are limited and controversial. Furthermore, there is no data on the effect of ACD on exercise capacity of COPD subjects.
Based to the aforementioned, this study has three goals:
- to determine the prevalence and the epidemiologic characteristics of ACD in a population of clinical stable COPD patients
- to investigate whether the levels of serum inflammatory markers and of plasma erythropoietin differ between COPD patients with ACD and without ACD
- to determine potential differences regarding the aerobic exercise capacity between these two groups, using the cardiopulmonary exercise testing (CPET).
- Being tested
- maximal cardiopulmonary exercise testing, peripheral blood samples
- Keywords
- COPD, anemia, exercise, cytokines, erythropoietin
- Medical subject headings
- Anemia, Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maximal cardiopulmonary exercise testingProcedure or surgery
Cardiopulmonary exercise testing (CPET) will be performed on a cyclic ergometer with continuous monitoring of a 12-lead electrocardiogram, heart rate and blood pressure. While breathing with a mask, the patients will perform a ramp protocol which includes 2-minutes free pedaling and progressive increase of power by 10, 15 or 20 watts/minute; power size will be selected after considering the patient' s daily activity and parameters of pulmonary function. CPET will be performed until exhaustion, unless the subjects reveal symptoms or signs indicating the exercise should stop (e.g. severe breathlessness).
peripheral blood samplesProcedure or surgery
Peripheral venous blood samples will be collected again in the morning after a fasting period of ≥12 hours. After immediate centrifugation, aliquots will be stored at -75˚C until analysis. Inflammatory markers and erythropoietin will be analyzed by flow cytometry and by enzyme-linked immunosorbent assay, using commercially available kits.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with ACD | Other | In the 1st part of this clinical study the prevalence ACD in COPD subjects will be estimated in a consecutive population of COPD subjects who will visit the hospital's pulmonary clinics as outpatients. During the first visit, subjects will give a detailed medical history and will undergo clinical examination and pulmonary function testing 15 minutes post-bronchodilation. Eligible patients will then undergo peripheral venous blood analysis. The first 30 COPD subjects from the population described above, fulfilling the criteria of ACD will constitute the first arm (group of "cases").ACD is defined by low Hb levels (men: <13 mg/dl, women: <12 mg/dl), no other cause of anemia present, normal or increased serum ferritin and decreased total iron binding capacity. Receives: Procedure: maximal cardiopulmonary exercise testing; Procedure: peripheral blood samples |
| COPD patients without ACD | Other | Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls") Receives: Procedure: maximal cardiopulmonary exercise testing; Procedure: peripheral blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD.
Measured: Within 15 days from enrollment
Secondary outcomes (4)
Serum levels of inflammatory markers
Measured: Within 15 days from enrollment
Erythropoietin
Measured: Within 15 days from enrollment
MRC dyspnea scale
Measured: Within 15 days from enrollment
The rest cardiopulmonary exercise testing parameters
Measured: Within 15 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Paraskevi Argyropoulou, MD, Prof, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033175
- Sponsor's protocol ID
- 8/22.1.08
- Status last verified
- Dec 2009
- First submitted
- 15 Dec 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available.
PubMed 7582322American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT01033175
- Acronym / sponsor ID
- 8/22.1.08
- Keywords
- COPD, anemia, exercise, cytokines, erythropoietin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Dec 2009 (estimated)
- 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.
Hypothesis:
The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. exercise capacity does not differ between COPD patients with and without ACD.
Rationale-Aim:
ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory diseases. COPD is a disorder very likely to be associated to ACD due to its systemic inflammatory dimension. Currently, data on the prevalence of ACD and on the level of inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are limited and controversial. Furthermore, there is no data on the effect of ACD on exercise capacity of COPD subjects.
Based to the aforementioned, this study has three goals:
- to determine the prevalence and the epidemiologic characteristics of ACD in a population of clinical stable COPD patients
- to investigate whether the levels of serum inflammatory markers and of plasma erythropoietin differ between COPD patients with ACD and without ACD
- to determine potential differences regarding the aerobic exercise capacity between these two groups, using the cardiopulmonary exercise testing (CPET).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with ACD | Other | Procedure: maximal cardiopulmonary exercise testing, Procedure: peripheral blood samplesIn the 1st part of this clinical study the prevalence ACD in COPD subjects will be estimated in a consecutive population of COPD subjects who will visit the hospital's pulmonary clinics as outpatients. During the first visit, subjects will give a detailed medical history and will undergo clinical examination and pulmonary function testing 15 minutes post-bronchodilation. Eligible patients will then undergo peripheral venous blood analysis. The first 30 COPD subjects from the population described above, fulfilling the criteria of ACD will constitute the first arm (group of "cases").ACD is defined by low Hb levels (men: <13 mg/dl, women: <12 mg/dl), no other cause of anemia present, normal or increased serum ferritin and decreased total iron binding capacity. |
| COPD patients without ACD | Other | Procedure: maximal cardiopulmonary exercise testing, Procedure: peripheral blood samplesThirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls") |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1st part of the study:
Key exclusion criteria (32 listed)
- 1st part of the study:
- 2nd and 3rd part: As above and additionally:
- acute myocardial infarction (in the last 6 months)
- unstable angina
- left main coronary stenosis or its equivalent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maximal cardiopulmonary exercise testingCardiopulmonary exercise testing (CPET) will be performed on a cyclic ergometer with continuous monitoring of a 12-lead electrocardiogram, heart rate and blood pressure. While breathing with a mask, the patients will perform a ramp protocol which includes 2-minutes free pedaling and progressive increase of power by 10, 15 or 20 watts/minute; power size will be selected after considering the patient' s daily activity and parameters of pulmonary function. CPET will be performed until exhaustion, unless the subjects reveal symptoms or signs indicating the exercise should stop (e.g. severe breathlessness). | Procedure or surgery | COPD patients with ACD, COPD patients without ACD |
| peripheral blood samplesPeripheral venous blood samples will be collected again in the morning after a fasting period of ≥12 hours. After immediate centrifugation, aliquots will be stored at -75˚C until analysis. Inflammatory markers and erythropoietin will be analyzed by flow cytometry and by enzyme-linked immunosorbent assay, using commercially available kits. | Procedure or surgery | COPD patients with ACD, COPD patients without ACD |
Primary outcome
The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD.
Time frame: Within 15 days from enrollment
4 secondary outcomes
Serum levels of inflammatory markers
Time frame: Within 15 days from enrollment
Erythropoietin
Time frame: Within 15 days from enrollment
MRC dyspnea scale
Time frame: Within 15 days from enrollment
The rest cardiopulmonary exercise testing parameters
Time frame: Within 15 days from enrollment
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 7 Jul 2010.
- Background: PubMed 15758012Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
- Background: PubMed 7582322Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available.
- Background: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
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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.
Paraskevi Argyropoulou, MD, Prof principal investigator
Aristotle University Of Thessaloniki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maximal cardiopulmonary exercise testing and peripheral blood samples in people with Anemia and COPD, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 4 inclusion and 32 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD. (time frame: Within 15 days from enrollment). 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 NCT01033175, which also lists 3 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 7 Jul 2010.