Pulmonary Function, Chronic Obstructive Pulmonary Disease (COPD) Prevalence, and Systemic Inflammation in Chronic Heart Failure With or Without COPD

NCT01429376 | Completed

• 1 other identifier: LTC-607-070409
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the present study is:

1. 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. 2.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.
3. 3.To investigate the presence of systemic inflammation, as measured by inflammatory parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or without COPD.

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Inflammation

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

Outcome Measures

Primary Outcomes (3)

• Pulmonary function abnormalities

  Restriction, obstruction, diffusion impairment, mixed pulmonary defects

  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.

  3 months

• Systemic inflammation

  Leukocytes, platelets, high sensitivity CRP.

  1 day

Secondary Outcomes (3)

• Quality of life

  3 months

• Dyspnoea

  3 months

• Independent predictors of COPD

  3 months

Interventions

Pulmonary function tests OTHER

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 tests OTHER

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.

Questionnaires OTHER

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 radiograph OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure patients with left ventricular systolic dysfunction (left ventricular ejection fraction \< 40%)
• Outpatients
• New York Heart Association (NYHA) class I-IV
• years and older
• Informed consent

You may not qualify if:

• 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
• 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
• Pericardial: major pericardial effusion
• Large mediastinal processes
• Collagen vascular diseases
• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Rijnstate Hospital

Zevenaar, Gelderland, 6903 ZN, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 26487748 DERIVED

• Minasian 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.

  PMID: 25285269 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Inflammation; Airway Obstruction

Interventions

Respiratory Physiological Phenomena; Hematologic Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Armine G Minasian, MD

  Rijnstate Hospital, Arnhem, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 7, 2011
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

NL (2)