NCT01801722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

February 25, 2013

Last Update Submit

March 6, 2018

Conditions

Chronic Obstructive Pulmonary DiseaseChronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with elevated NT-proBNP.

    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.

    3 months

Secondary Outcomes (1)

  • Percentage of patients with abnormal left ventricular function assessed by echocardiography. Association between elevated NT-proBNP and symptoms, signs and electrocardiography.

    3 months

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 years and older with a registered diagnosis of COPD.

You may qualify if:

  • 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.

You may not qualify if:

  • Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
  • psychiatric disorders or terminal illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary health care center.

Olofström, Blekinge County, 29332, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elzbieta Kaszuba, PhD student

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 1, 2013

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

SE(1)