NCT07576894

Brief Summary

This study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
52mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress15%
Aug 2025Aug 2030

Study Start

First participant enrolled

August 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

4.8 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

COPDPulmonary hypertensionExercisePulmonary rehabilitationExercise training

Outcome Measures

Primary Outcomes (1)

  • Right ventricular contractility measured by transthoracic echocardiography

    Global longitudinal strain, measured in absolute percent

    Up to 1 hour

Secondary Outcomes (7)

  • Right ventricular contractility measured by conductance catheter

    Up to 1 hour

  • Right ventricular systolic function measured by transthoracic echocardiography

    Up to 1 hour

  • Right ventricular systolic function measured by transthoracic echocardiography

    Up to 1 hour

  • Exercise training feasibility

    4 months

  • Exercise training safety

    4 months

  • +2 more secondary outcomes

Study Arms (1)

COPD

EXPERIMENTAL

Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses. Participants who based on baseline testing are eligible and decide to participate in the optional exercise training program will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction.

Behavioral: Exercise training

Interventions

Exercise training will include moderate-intensity interval training 3x/week.

COPD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7)
  • Age \>= 40 years

You may not qualify if:

  • Exacerbation of COPD in the 3 months prior to enrollment
  • Change in COPD therapy in the 3 weeks prior to enrollment
  • Requirement of \>6 LPM supplemental oxygen at rest
  • Requirement of \>10 LPM supplemental oxygen with exertion
  • Active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure \>150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; uncontrolled arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)
  • Volume overload (jugular vascular distension or greater than trace peripheral edema)
  • World Health Organization Functional Class IV
  • Known pulmonary hypertension with mean pulmonary artery pressure \>45 mmHg
  • Untreated severe obstructive sleep apnea and/or obesity hypoventilation syndrome
  • Active malignancy (other than skin)
  • Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance/gait instability, etc.)
  • Pregnancy
  • Body mass index \<18 or \>35
  • Hematocrit \<25% or \>55%
  • For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypertension, PulmonaryMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lindsay Forbes, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations