AnemiaANCHORNCT00834691
An Evaluation of the Causes of Anemia in Patients With Heart Failure
An observational study of Anemia and Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
Anemia is frequent in patients with heart failure. Few studies have clearly addressed the causes of anemia in patients with HF. The purpose of this study is to evaluate differences in blood concentrations of various substances related to inflammation, oxidative stress, renal function and other processes between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Heart Failure, Chronic Renal Failure
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Feb 2010
- 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: One hundred and eighty (180) patients will be enrolled in three groups. Group 1: This group will involve 80 patients with anemia (hemoglobin < 120g/L in women and < 130 g/L in) and systolic heart failure (LVEF < or = 40%; New York Heart Association -NYHA- functionnal class II-IV). Group 2: This group will include 50 patients with systolic heart failure (LVEF < or = 40%; New York Heart Association -NYHA- functionnal class II-IV), but without anemia (hemoglobin > or = 120g/L in women and > or = 130 g/L in men). Group 3 : 50 patients with at least moderate CRF (eGFR < 60ml/min/1,73m2), and LVEF > or = 50%, with or without anemia.
Who may be able to join
- Groups 1 and 2
- Age >18 years
- Group 1: hemoglobin < 120g/L in women and < 130 g/L in men (in agreement with the WHO definition of anemia)
- Group 2: hemoglobin > or = 120g/L in women and > or = 130 g/L in men
- Patients with chronic HF referred to a specialized HF clinic, or with a diagnosis of HF at least 6 months prior to enrolment
- NYHA functional class II-IV at the time of enrolment
Show all 12Show fewer
- Patients already on CHF medical therapy (ACEI or ARBs, beta-blockers if tolerated, with or without digoxin, and loop diuretics), at stable doses for > or = 1 month
- LVEF < or = 40% within 6 months prior to patient enrolment, by echocardiography, radionuclide ventriculography or perfusion scan, or radiologic angiography
- Age >18 years
- At least moderate CRF (eGFR < 60ml/min/1,73m2)
- With or without anemia
- LVEF > or = 50% within 6 months prior to patient enrolment, by echocardiography, radionuclide ventriculography or perfusion scan, or radiologic angiography
Who cannot join
- Recent acute renal failure episode (< 1 month)
- Red blood cells (or other blood component) transfusions or EPO therapy within 3 months prior to enrolment
- Iron, B12 or folic acid supplements used to treat anemia (< 3 months)
- Evidence of active GI bleeding
- Recent acute coronary syndrome or decompensated HF episode (< 1 month)
- Complex congenital heart disease
Show all 14Show fewer
- Known malignant hematologic or other active neoplasia
- Immunosuppressive therapy, chemotherapy or radiotherapy within 3 months prior to enrolment
- Recent acute decompensation of a chronic inflammatory disease (e.g. chronic inflammatory bowel disease, rheumatoid arthritis, collagen vascular disease) within 3 months prior to enrolment
- Recent viral or bacterial syndrome (< 2 weeks)
- Active or recent viral hepatitis (< 3 months)
- Pregnant women
- Potential for non compliance to tests involved in this protocol
- Incapacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anemia in Chronic Heart Failure: Etiology, Comparisons With Renal Disease, and Relationships With Biomarkers and Left Ventricular Remodeling.
Anemia is frequent in patients with heart failure. Few studies have clearly addressed the causes of anemia in patients with HF. The purpose of this study is to evaluate differences in blood concentrations of various substances related to inflammation, oxidative stress, renal function and other processes between individuals with 1) heart failure and anemia, 2) heart failure without anemia and 3) patients with kidney disease without systolic heart failure. This study will help to better understand the reasons why some people with heart failure have anemia.
- Conditions
- Anemia, Heart Failure, Chronic Renal Failure
- Keywords
- Inflammation, Oxidative stress, Estimated glomerular filtration rate
- Medical subject headings
- Anemia, Heart Failure, Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with anemia and systolic heart failure | |
| 2 | Patients with systolic heart failure but without anemia | |
| 3 | Patients with at least moderate chronic renal failure, with or without anemia and without systolic heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF alpha concentrations
Measured: Visit 2 (within 2 weeks of baseline visit)
Secondary outcomes (1)
Various echocardiographic measurements, markers of inflammation, oxydative stress, neurohormonal activity and myocardial extracellular matrix turnover will be measured
Measured: Visit 2 (within 2 weeks of baseline visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionFeb 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.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834691
- Sponsor's protocol ID
- 07-938
- Acronym
- ANCHOR
- Status last verified
- Jul 2010
- First submitted
- 30 Jan 2009
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Meara E, Clayton T, McEntegart MB, McMurray JJ, Lang CC, Roger SD, Young JB, Solomon SD, Granger CB, Ostergren J, Olofsson B, Michelson EL, Pocock S, Yusuf S, Swedberg K, Pfeffer MA; CHARM Committees and Investigators. Clinical correlates and consequences of anemia in a broad spectrum of patients with heart failure: results of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Program. Circulation. 2006 Feb 21;113(7):986-94. doi: 10.1161/CIRCULATIONAHA.105.582577. Epub 2006 Feb 13.
PubMed 16476847de Denus S, Tardif JC, White M, Bourassa MG, Racine N, Levesque S, Ducharme A. Temporal variations in hematocrit values in patients with left ventricular dysfunction: Relationship with cause-specific mortality and morbidity and optimal monitoring--further insights from SOLVD. Can J Cardiol. 2008 Jan;24(1):45-8. doi: 10.1016/s0828-282x(08)70547-6.
PubMed 18209768O'Meara E, Rouleau JL, White M, Roy K, Blondeau L, Ducharme A, Neagoe PE, Sirois MG, Lavoie J, Racine N, Liszkowski M, Madore F, Tardif JC, de Denus S; ANCHOR Investigators. Heart failure with anemia: novel findings on the roles of renal disease, interleukins, and specific left ventricular remodeling processes. Circ Heart Fail. 2014 Sep;7(5):773-81. doi: 10.1161/CIRCHEARTFAILURE.114.001100. Epub 2014 Jul 15.
PubMed 25027873
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia in Chronic Heart Failure: Etiology, Comparisons With Renal Disease, and Relationships With Biomarkers and Left Ventricular Remodeling.
- ClinicalTrials.gov ID
- NCT00834691
- Acronym / sponsor ID
- ANCHOR / 07-938
- Conditions
- Anemia, Heart Failure, Chronic Renal Failure
- Keywords
- Inflammation, Oxidative stress, Estimated glomerular filtration rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- First posted
- 3 Feb 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.
Anemia is frequent in patients with heart failure. Few studies have clearly addressed the causes of anemia in patients with HF. The purpose of this study is to evaluate differences in blood concentrations of various substances related to inflammation, oxidative stress, renal function and other processes between individuals with 1) heart failure and anemia, 2) heart failure without anemia and 3) patients with kidney disease without systolic heart failure. This study will help to better understand the reasons why some people with heart failure have anemia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with anemia and systolic heart failure |
| 2 | – | –Patients with systolic heart failure but without anemia |
| 3 | – | –Patients with at least moderate chronic renal failure, with or without anemia and without systolic heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and eighty (180) patients will be enrolled in three groups. Group 1: This group will involve 80 patients with anemia (hemoglobin < 120g/L in women and < 130 g/L in) and systolic heart failure (LVEF < or = 40%; New York Heart Association -NYHA- functionnal class II-IV). Group 2: This group will include 50 patients with systolic heart failure (LVEF < or = 40%; New York Heart Association -NYHA- functionnal class II-IV), but without anemia (hemoglobin > or = 120g/L in women and > or = 130 g/L in men). Group 3 : 50 patients with at least moderate CRF (eGFR < 60ml/min/1,73m2), and LVEF > or = 50%, with or without anemia.
Key inclusion criteria (12 listed)
- Groups 1 and 2
- Age >18 years
- Group 1: hemoglobin < 120g/L in women and < 130 g/L in men (in agreement with the WHO definition of anemia)
- Group 2: hemoglobin > or = 120g/L in women and > or = 130 g/L in men
- Patients with chronic HF referred to a specialized HF clinic, or with a diagnosis of HF at least 6 months prior to enrolment
Key exclusion criteria (14 listed)
- Recent acute renal failure episode (< 1 month)
- Red blood cells (or other blood component) transfusions or EPO therapy within 3 months prior to enrolment
- Iron, B12 or folic acid supplements used to treat anemia (< 3 months)
- Evidence of active GI bleeding
- Recent acute coronary syndrome or decompensated HF episode (< 1 month)
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
TNF alpha concentrations
Time frame: Visit 2 (within 2 weeks of baseline visit)
1 secondary outcome
Various echocardiographic measurements, markers of inflammation, oxydative stress, neurohormonal activity and myocardial extracellular matrix turnover will be measured
Time frame: Visit 2 (within 2 weeks of baseline visit)
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 2 Aug 2010.
- Background: PubMed 16476847O'Meara E, Clayton T, McEntegart MB, McMurray JJ, Lang CC, Roger SD, Young JB, Solomon SD, Granger CB, Ostergren J, Olofsson B, Michelson EL, Pocock S, Yusuf S, Swedberg K, Pfeffer MA; CHARM Committees and Investigators. Clinical correlates and consequences of anemia in a broad spectrum of patients with heart failure: results of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Program. Circulation. 2006 Feb 21;113(7):986-94. doi: 10.1161/CIRCULATIONAHA.105.582577. Epub 2006 Feb 13.
- Background: PubMed 18209768de Denus S, Tardif JC, White M, Bourassa MG, Racine N, Levesque S, Ducharme A. Temporal variations in hematocrit values in patients with left ventricular dysfunction: Relationship with cause-specific mortality and morbidity and optimal monitoring--further insights from SOLVD. Can J Cardiol. 2008 Jan;24(1):45-8. doi: 10.1016/s0828-282x(08)70547-6.
- Derived from this study: PubMed 25027873O'Meara E, Rouleau JL, White M, Roy K, Blondeau L, Ducharme A, Neagoe PE, Sirois MG, Lavoie J, Racine N, Liszkowski M, Madore F, Tardif JC, de Denus S; ANCHOR Investigators. Heart failure with anemia: novel findings on the roles of renal disease, interleukins, and specific left ventricular remodeling processes. Circ Heart Fail. 2014 Sep;7(5):773-81. doi: 10.1161/CIRCHEARTFAILURE.114.001100. Epub 2014 Jul 15.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
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 12 inclusion and 14 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 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
TNF alpha concentrations (time frame: Visit 2 (within 2 weeks of baseline visit)). 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 NCT00834691, 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 2 Aug 2010.