Heart FailureNCT01429376
Pulmonary Function, Chronic Obstructive Pulmonary Disease (COPD) Prevalence, and Systemic Inflammation in Chronic Heart Failure With or Without COPD
A study testing Pulmonary function tests, Blood tests and Questionnaires in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by Rijnstate Hospital at 2 sites in Netherlands.
Trial summary
The aim of the present study is: 1. To investigate pulmonary function abnormalities (restriction, obstruction, diffusion impairment, mixed pulmonary defects) in patients with chronic heart failure (CHF) and to determine which of these pulmonary abnormalities prevail and to what extent. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Inflammation
- What is being tested?
- Pulmonary function tests, Blood tests and Questionnaires
- How many people
- 234 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2009to Jun 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure patients with left ventricular systolic dysfunction (left ventricular ejection fraction < 40%)
- Outpatients
- New York Heart Association (NYHA) class I-IV
- 18 years and older
- Informed consent
Who cannot join
- Patients who do not meet the inclusion criteria
- Patients who are not able to cooperate or undergo pulmonary function tests
- Other diseases that can lead to obstructive lung function: asthma, cystic fibrosis
- Malignancy with bad prognosis (survival < 6 months)
- Hospitalisation to the pulmonary department in the past 6 weeks, in this case patients will have the pulmonary function tests ≥ 6 weeks after discharge
- Patients who are already participating in another study within the cardiology department
Show all 28Show fewer
- Additional exclusion criteria for the first primary objective:
- Disorders/diseases that can lead to pulmonary function impairment:
- Pulmonary: lung surgery (lobectomy/pneumectomy), parenchymal neoplasms, interstitial lung disease, sarcoidosis, pneumoconioses, lung abscess, lobar pneumonia, post- infectious scarring, atelectasis, radiation fibrosis
- Pleural: diffuse pleural thickening, mesothelioma, pleural effusion not due to heart failure, pneumothorax
- Neuromuscular diseases: ALS, poliomyelitis, myopathy, bilateral diaphragmatic paralysis, high spinal cord lesions, myasthenia gravis
- Abdominal: obesity (BMI > 35) (exclusion only from the restriction prevalence analysis)
- Pericardial: major pericardial effusion
- Large mediastinal processes
- Collagen vascular diseases
- Additional exclusion criteria for the third primary objective:
- Active/recent infection
- Febrile or inflammatory disease such as rheumatoid arthritis
- Use of antibiotics or anti-inflammatory medication, such as etanercept, infliximab, systemic use of corticosteroids and NSAID's other than acetylsalicylic acid
- Malignancy
- Auto-immune disease
- Collagenvascular disease
- Gastro-intestinal disease (such as inflammatory bowel disease)
- Recent operation (past 3 months)
- Renal or liver failure
- Thyroid disease
- Obstructive sleep apnoea syndrome (OSAS)
- Disorders that lead to thrombocytopenia/leukocytopenia or thrombocytosis/leukocytosis (hs-CRP analysis will take place in case these disorders do not affect hs-CRP)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem, Gelderland, 6800 TA
Rijnstate Hospital
Zevenaar, Gelderland, 6903 ZN
About this study
Official title: 1) Pulmonary Function in CHF; 2) COPD Prevalence, Underdiagnosis and Overdiagnosis in CHF Patients and Its Independent Predictors; 3) Are There Signs of Systemic Inflammation in CHF With or Without COPD?
The aim of the present study is:
- To investigate pulmonary function abnormalities (restriction, obstruction, diffusion impairment, mixed pulmonary defects) in patients with chronic heart failure (CHF) and to determine which of these pulmonary abnormalities prevail and to what extent.
- To determine the prevalence, underdiagnosis, and overdiagnosis of chronic obstructive pulmonary disease (COPD) as determined by spirometry and according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.
- To investigate the presence of systemic inflammation, as measured by inflammatory parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or without COPD.
Read the detailed description
- The impact of chronic heart failure (CHF) on pulmonary function is incompletely understood and remains controversial. It is difficult to separate the contribution of stable CHF from underlying pulmonary disease and other confounding influences, such as changes due to normal ageing, obesity, environmental exposure (mainly smoking), stability of disease, a history of coronary artery bypass grafting, and other conditions that can lead to pulmonary function abnormalities. Studies have shown that isolated or combined pulmonary function impairment, such as diffusion impairment, restriction, and to a much lesser extent airway obstruction are common in patients with CHF and can contribute to the perception of dyspnoea and exercise intolerance. Pulmonary dysfunction increases with the severity of heart failure and provides important prognostic information. Most investigators compared pulmonary function in CHF patients with normal predicted values or control subjects. However, there is only a small body of literature addressing the prevalence of different pulmonary function abnormalities in patients with CHF. In addition, these studies have included (potential) heart transplant recipients, who represent one extreme of the heart failure spectrum. The aim of the present study was to investigate the prevalence of pulmonary function abnormalities in patients with CHF and to determine which of these pulmonary abnormalities prevail and to what extent.
- Chronic obstructive pulmonary disease (COPD) frequently coexists with CHF, leading to impaired prognosis as well as diagnostic and therapeutic challenges. However, lung functional data on COPD prevalence in CHF are scarce and COPD remains widely undiagnosed or misdiagnosed. The reported prevalence rates of COPD range from 9 to 41% in European cohorts and from 11 to 52% in North American patients with heart failure. The purpose of this study was to determine the prevalence, underdiagnosis, and overdiagnosis of COPD as determined by spirometry and according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.
- There is abundant evidence of increased systemic inflammation in both CHF and COPD and it is remarkable to observe the similarities of inflammation in both conditions. These inflammatory responses may provide a mechanistic bridge between COPD and cardiac co-morbidity. However, there is no information regarding systemic inflammation when CHF and COPD coexist. It is unknown whether the combination of these two diseases leads to increased systemic inflammation in comparison to CHF alone. The aim of this study was to investigate the presence of systemic inflammation, as measured by inflammatory parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or without COPD.
- Being tested
- Pulmonary function tests, Blood tests, Questionnaires, Chest radiograph
- Keywords
- Chronic heart failure, Pulmonary function abnormalities/impairment, Restriction, Airway obstruction, Diffusion impairment, Pulmonary function tests, Chronic obstructive pulmonary disease (COPD), Prevalence, Overdiagnosis, Underdiagnosis, Systemic inflammation, Diagnostic Errors
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Inflammation, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testsOther
Patients underwent several pulmonary function tests (spirometry, diffusion measurement, body plethysmography) according to the study protocol 1 month after the first blood sample. COPD was diagnosed post-bronchodilation according to GOLD guidelines. Patients with newly diagnosed COPD received standard treatment for COPD. Spirometry was repeated after 3 months of standard treatment for COPD in patients with newly diagnosed COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma.
Blood testsOther
First blood sample (day 1): NT-pro-BNP, sodium, potassium, urea, creatinin, glomerular filtration rate (GFR).
Second blood sample (after 1 month): NT-pro-BNP, sodium, potassium, urea, creatinin, GFR, haemoglobin, and arterial blood gas analysis in patients with GOLD III COPD. For systemic inflammation substudy also high sensitivity CRP, leukocytes, and platelets.
Third blood sample (after 3 months from second blood sample): NT-pro-BNP, sodium, potassium, urea, creatinin, and GFR.
QuestionnairesOther
Minnesota Living with Heart Failure Questionnaire (MLHFQ), modified Medical Research Council (MRC) dyspnoea scale, 10-point Borg dyspnoea score.
All questionnaires were completed on the day of initial pulmonary function tests and three months later.
Chest radiographOther
Standard posteroanterior and lateral chest radiographs were performed and evaluated on the presence or absence of congestion and other conditions that belonged to the exclusion criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function abnormalities
Restriction, obstruction, diffusion impairment, mixed pulmonary defects
Measured: 1 day
COPD prevalence, underdiagnosis, and overdiagnosis
Patients with newly diagnosed COPD repeated spirometry after 3 months of standard treatment for COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma.
Measured: 3 months
Systemic inflammation
Leukocytes, platelets, high sensitivity CRP.
Measured: 1 day
Secondary outcomes (3)
Quality of life
Minnesota Living with Heart Failure Questionnaire (MLHFQ), on the day of initial pulmonary function tests and 3 months later.
Measured: 3 months
Dyspnoea
modified Medical Research Council (MRC) dyspnea scale and 10-point Borg dyspnoea score, on the day of initial pulmonary function tests and 3 months later.
Measured: 3 months
Independent predictors of COPD
Patients characterisitcs, such as age, gender, body mass index, symptoms, smoking history, family history, and so on.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Armine G Minasian, MD, Principal investigator, Rijnstate Hospital, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429376
- Sponsor's protocol ID
- LTC-607-070409
- Status last verified
- Sep 2011
- First submitted
- 2 Sep 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Minasian AG, van den Elshout FJ, Dekhuijzen PN, Vos PJ, Willems FF, van den Bergh PJ, Heijdra YF. Using the Lower Limit of Normal Instead of the Conventional Cutoff Values to Define Predictors of Pulmonary Function Impairment in Subjects With Chronic Heart Failure. Respir Care. 2016 Feb;61(2):173-83. doi: 10.4187/respcare.04101. Epub 2015 Oct 20.
PubMed 26487748Minasian AG, van den Elshout FJ, Dekhuijzen PR, Vos PJ, Willems FF, van den Bergh PJ, Heijdra YF. Serial pulmonary function tests to diagnose COPD in chronic heart failure. Transl Respir Med. 2014 Dec;2(1):12. doi: 10.1186/s40247-014-0012-5. Epub 2014 Sep 25.
PubMed 25285269
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1) Pulmonary Function in CHF; 2) COPD Prevalence, Underdiagnosis and Overdiagnosis in CHF Patients and Its Independent Predictors; 3) Are There Signs of Systemic Inflammation in CHF With or Without COPD?
- ClinicalTrials.gov ID
- NCT01429376
- Acronym / sponsor ID
- LTC-607-070409
- Keywords
- Chronic heart failure, Pulmonary function abnormalities/impairment, Restriction, Airway obstruction, Diffusion impairment, Pulmonary function tests, Chronic obstructive pulmonary disease (COPD), Prevalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Sep 2011 (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.
The aim of the present study is:
- To investigate pulmonary function abnormalities (restriction, obstruction, diffusion impairment, mixed pulmonary defects) in patients with chronic heart failure (CHF) and to determine which of these pulmonary abnormalities prevail and to what extent.
- To determine the prevalence, underdiagnosis, and overdiagnosis of chronic obstructive pulmonary disease (COPD) as determined by spirometry and according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.
- To investigate the presence of systemic inflammation, as measured by inflammatory parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or without COPD.
Detailed description
- The impact of chronic heart failure (CHF) on pulmonary function is incompletely understood and remains controversial. It is difficult to separate the contribution of stable CHF from underlying pulmonary disease and other confounding influences, such as changes due to normal ageing, obesity, environmental exposure (mainly smoking), stability of disease, a history of coronary artery bypass grafting, and other conditions that can lead to pulmonary function abnormalities. Studies have shown that isolated or combined pulmonary function impairment, such as diffusion impairment, restriction, and to a much lesser extent airway obstruction are common in patients with CHF and can contribute to the perception of dyspnoea and exercise intolerance. Pulmonary dysfunction increases with the severity of heart failure and provides important prognostic information. Most investigators compared pulmonary function in CHF patients with normal predicted values or control subjects. However, there is only a small body of literature addressing the prevalence of different pulmonary function abnormalities in patients with CHF. In addition, these studies have included (potential) heart transplant recipients, who represent one extreme of the heart failure spectrum. The aim of the present study was to investigate the prevalence of pulmonary function abnormalities in patients with CHF and to determine which of these pulmonary abnormalities prevail and to what extent.
- Chronic obstructive pulmonary disease (COPD) frequently coexists with CHF, leading to impaired prognosis as well as diagnostic and therapeutic challenges. However, lung functional data on COPD prevalence in CHF are scarce and COPD remains widely undiagnosed or misdiagnosed. The reported prevalence rates of COPD range from 9 to 41% in European cohorts and from 11 to 52% in North American patients with heart failure. The purpose of this study was to determine the prevalence, underdiagnosis, and overdiagnosis of COPD as determined by spirometry and according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.
- There is abundant evidence of increased systemic inflammation in both CHF and COPD and it is remarkable to observe the similarities of inflammation in both conditions. These inflammatory responses may provide a mechanistic bridge between COPD and cardiac co-morbidity. However, there is no information regarding systemic inflammation when CHF and COPD coexist. It is unknown whether the combination of these two diseases leads to increased systemic inflammation in comparison to CHF alone. The aim of this study was to investigate the presence of systemic inflammation, as measured by inflammatory parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or without COPD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic heart failure patients with left ventricular systolic dysfunction (left ventricular ejection fraction < 40%)
- Outpatients
- New York Heart Association (NYHA) class I-IV
- 18 years and older
- Informed consent
Key exclusion criteria (28 listed)
- Patients who do not meet the inclusion criteria
- Patients who are not able to cooperate or undergo pulmonary function tests
- Other diseases that can lead to obstructive lung function: asthma, cystic fibrosis
- Malignancy with bad prognosis (survival < 6 months)
- Hospitalisation to the pulmonary department in the past 6 weeks, in this case patients will have the pulmonary function tests ≥ 6 weeks after discharge
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 |
|---|---|---|
| Pulmonary function testsPatients underwent several pulmonary function tests (spirometry, diffusion measurement, body plethysmography) according to the study protocol 1 month after the first blood sample. COPD was diagnosed post-bronchodilation according to GOLD guidelines. Patients with newly diagnosed COPD received standard treatment for COPD. Spirometry was repeated after 3 months of standard treatment for COPD in patients with newly diagnosed COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma. | Other | – |
| Blood testsFirst blood sample (day 1): NT-pro-BNP, sodium, potassium, urea, creatinin, glomerular filtration rate (GFR). Second blood sample (after 1 month): NT-pro-BNP, sodium, potassium, urea, creatinin, GFR, haemoglobin, and arterial blood gas analysis in patients with GOLD III COPD. For systemic inflammation substudy also high sensitivity CRP, leukocytes, and platelets. Third blood sample (after 3 months from second blood sample): NT-pro-BNP, sodium, potassium, urea, creatinin, and GFR. | Other | – |
| QuestionnairesMinnesota Living with Heart Failure Questionnaire (MLHFQ), modified Medical Research Council (MRC) dyspnoea scale, 10-point Borg dyspnoea score. All questionnaires were completed on the day of initial pulmonary function tests and three months later. | Other | – |
| Chest radiographStandard posteroanterior and lateral chest radiographs were performed and evaluated on the presence or absence of congestion and other conditions that belonged to the exclusion criteria. | Other | – |
Primary outcome
Pulmonary function abnormalities
Time frame: 1 day
Restriction, obstruction, diffusion impairment, mixed pulmonary defects
COPD prevalence, underdiagnosis, and overdiagnosis
Time frame: 3 months
Patients with newly diagnosed COPD repeated spirometry after 3 months of standard treatment for COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma.
Systemic inflammation
Time frame: 1 day
Leukocytes, platelets, high sensitivity CRP.
3 secondary outcomes
Quality of life
Time frame: 3 months
Dyspnoea
Time frame: 3 months
Independent predictors of COPD
Time frame: 3 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 7 Sep 2011.
- Derived from this study: PubMed 26487748Minasian AG, van den Elshout FJ, Dekhuijzen PN, Vos PJ, Willems FF, van den Bergh PJ, Heijdra YF. Using the Lower Limit of Normal Instead of the Conventional Cutoff Values to Define Predictors of Pulmonary Function Impairment in Subjects With Chronic Heart Failure. Respir Care. 2016 Feb;61(2):173-83. doi: 10.4187/respcare.04101. Epub 2015 Oct 20.
- Derived from this study: PubMed 25285269Minasian AG, van den Elshout FJ, Dekhuijzen PR, Vos PJ, Willems FF, van den Bergh PJ, Heijdra YF. Serial pulmonary function tests to diagnose COPD in chronic heart failure. Transl Respir Med. 2014 Dec;2(1):12. doi: 10.1186/s40247-014-0012-5. Epub 2014 Sep 25.
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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.
Armine G Minasian, MD principal investigator
Rijnstate Hospital, Arnhem, The Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary function tests, Blood tests and Questionnaires in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by Rijnstate Hospital at 2 sites in Netherlands.
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 5 inclusion and 28 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 Sep 2011. 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 Netherlands. 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?
Pulmonary function abnormalities (time frame: 1 day). The study lists 3 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 NCT01429376, which also lists 2 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 Sep 2011.