Pulmonary Function, Chronic Obstructive Pulmonary Disease (COPD) Prevalence, and Systemic Inflammation in Chronic Heart Failure With or Without COPD
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|ClinicalTrials.gov Identifier: NCT01429376|
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Pulmonary Disease, Chronic Obstructive Inflammation||Other: Pulmonary function tests Other: Blood tests Other: Questionnaires Other: Chest radiograph||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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?|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||June 2011|
- Other: Pulmonary function tests
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.
- Other: Blood tests
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.
- Other: Questionnaires
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.
- Other: Chest radiograph
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.
- 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.
- Quality of life [ Time Frame: 3 months ]Minnesota Living with Heart Failure Questionnaire (MLHFQ), on the day of initial pulmonary function tests and 3 months later.
- Dyspnoea [ Time Frame: 3 months ]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.
- Independent predictors of COPD [ Time Frame: 3 months ]Patients characterisitcs, such as age, gender, body mass index, symptoms, smoking history, family history, and so on.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429376
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Zevenaar, Gelderland, Netherlands, 6903 ZN|
|Principal Investigator:||Armine G Minasian, MD||Rijnstate Hospital, Arnhem, The Netherlands|