NCT04277429

Brief Summary

This study was designed to assess potential relationship between heart failure with preserved ejection fraction and 2- year mortality of patients with chronic obstructive pulmonary disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

4.8 years

First QC Date

February 17, 2020

Last Update Submit

November 1, 2022

Conditions

Chronic Obstructive Pulmonary DiseaseHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality of patients

    2 year

Study Arms (3)

Normal cardiac function

Normal cardiac function

Diagnostic Test: Cardiac function assessment

Heart failure with reduced ejection fraction

Heart failure with reduced ejection fraction

Diagnostic Test: Cardiac function assessment

Heart failure with preserved ejection fraction

Heart failure with preserved ejection fraction

Diagnostic Test: Cardiac function assessment

Interventions

Cardiac function assessmentDIAGNOSTIC_TEST

Echocardiography, cardiac enzymes analysis

Heart failure with preserved ejection fractionHeart failure with reduced ejection fractionNormal cardiac function

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic obstructive pulmonary disease

You may qualify if:

  • Exacerbation of chronic obstructive pulmonary disease requiring hospitalization
  • Age 40 - 80 years
  • Performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG)
  • Long acting beta agonist (LABA)/ long acting antimuscarinic (LAMA) bronchodilator treatment

You may not qualify if:

  • Presence of major heart valve dysfunction
  • Documented noncompliance with treatment
  • Presence of active malignancy
  • Body mass index \> 40
  • Interstitial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frydek Mistek Hospital

Frýdek-Místek, Czechia

NOT YET RECRUITING

University Hospital Olomou

Olomouc, 77900, Czechia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

  • Milan Sova, Ph.D.

    Department of Respiratory Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Milan Sova, Ph.D.

CONTACT

588445326milan.sova@email.cz

Ondrej Zela, MD

CONTACT

ondrej.zela@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Respiratory Medicine

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 20, 2020

Study Start

July 1, 2020

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations

CZ(2)