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

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. 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. 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

Interventions

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.

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Rijnstate Hospital

  lead OTHER

Principal Investigators

• Armine G Minasian, MD · Rijnstate Hospital, Arnhem, The Netherlands

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2011-04-30

Completion

2011-06-30

Countries

• Netherlands

Study Locations