Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age41+
SponsorUniversity of Bari Aldo Moro

About this trial

The goal of this randomized clinical trial is to learn whether a combined cardio-pulmonary assessment improves cardiac function, exercise capacity, cardiac biomarkers and health-related quality of life in adults with mild-to-moderate chronic obstructive pulmonary disease (COPD) who are at high cardiovascular risk or have established cardiovascular disease.

The main questions it aims to answer are:

* Does the combined cardio-pulmonary assessment improve mean left ventricular ejection fraction (EF) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean 6-minute walk distance (6MWD) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment reduce mean NT-proBNP over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score over 12 months compared with standard respiratory care?

Researchers will compare a combined cardio-pulmonary assessment to standard respiratory care to see whether the integrated approach leads to greater improvements in EF, 6MWD, NT-proBNP, and KCCQ-12.

Participants will:

* Be randomly assigned to receive either a combined cardio-pulmonary assessment or standard respiratory care * Complete a baseline visit that includes clinical assessment, respiratory function testing, blood tests (including NT-proBNP), a 6-minute walk test, and the KCCQ-12 questionnaire * Undergo cardiovascular evaluation (electrocardiogram and transthoracic echocardiography) if assigned to the combined assessment group * Attend follow-up evaluation at 12 months, repeating the same assessments according to their assigned group

Eligibility criteria

Qualifiers

Post-bronchodilator FEV1 ≥ 50% or FEV1 z ≥ -2.5

Age > 40 years

Very high cardiovascular risk

Patients < 50 years old > 7.5%

Disqualifiers

Post-bronchodilator FEV1 < 50% or FEV1 z < -2.5

LTOLT

Active neoplasm

Patient unable to perform lung function

Trial design

Treatments tested in this trial

  • Structured combined cardio-pulmonary clinical management strategy
  • Standard Respiratory Management

Treatment groups

350 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators