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Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease (NT-proBNP)

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ClinicalTrials.gov Identifier: NCT01801722
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Elzbieta Kaszuba, Lund University

Tracking Information
First Submitted Date February 25, 2013
First Posted Date March 1, 2013
Last Update Posted Date March 7, 2018
Study Start Date April 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2013)
Percentage of patients with elevated NT-proBNP. [ Time Frame: 3 months ]
NT-proBNP has taken only once in each patient without follow up follow up. Three months was a period when we collected data from all participants.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2013)
Percentage of patients with abnormal left ventricular function assessed by echocardiography. Association between elevated NT-proBNP and symptoms, signs and electrocardiography. [ Time Frame: 3 months ]
Echocardiography was performed once in each referred patient. Three months was a period of data collection.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease
Official Title Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease.
Brief Summary The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography.
Detailed Description

Patients with a confirmed diagnosis of COPD were examined regarding chronic heart failure.

  1. An interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance.
  2. Physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema.
  3. Electrocardiography.
  4. Natriuretic peptide- NT-proBNP (Immulite 2500, Siemens Healthcare Diagnostics AB Sweden).
  5. Patients with the NT-proBNP level of > 1200 pg/ml were referred for echocardiography to assess left ventricular function.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged 65 years and older with a registered diagnosis of COPD.
Condition
  • Chronic Obstructive Pulmonary Disease
  • Chronic Heart Failure
Intervention Not Provided
Study Groups/Cohorts NT-proBNP,ejection fraction ,COPD stage.
The group comprised 25 women (47%) and 28 men (53%). The mean age was 75.4 years (SD 7.9), 76.3 (SD 7.6) for men and 74.4 (SD 8.2) for women.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 28, 2013)
75
Original Actual Enrollment Same as current
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged 65 years and older with the following diagnosis codes according to International Statistical Classification of Diseases and Related Health Problems - Tenth Revision:J44 (COPD) and J41, J42 (chronic bronchitis) registered during the period 1 January 2008-16 April 2008 according to the electronic patient record.

Exclusion Criteria:

  • Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
  • psychiatric disorders or terminal illness.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01801722
Other Study ID Numbers 502008
DN50/2008 ( Other Identifier: Ethics committee at Lund university )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elzbieta Kaszuba, Lund University
Study Sponsor Lund University
Collaborators Not Provided
Investigators
Principal Investigator: Elzbieta Kaszuba, PhD student Lund University
PRS Account Lund University
Verification Date March 2018