Skip to content

Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04663217
Acronym
EXERTION
Enrollment
120
Registered
2020-12-10
Start date
2020-11-01
Completion date
2023-11-04
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary, Hypertension, Pulmonary Arterial

Keywords

exercise, Hypertension, Pulmonary

Brief summary

This study aims to investigate the exercise profile in pulmonary hypertension patients with either pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to left heart disease and in disease control.

Detailed description

This is a dual-center observational prospective study in patients with pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, pulmonary hypertension due to left heart disease. Patients undergoing right heart catheterisation due to dyspnoe with invasive exclusion of pulmonary hypertension will be recruited as disease control. The study comprises a 1-day screening period, followed by a right heart catheterization with exercise challenge. The study starts with screening, information of the patients and Informed Consent Form signature at day -1. Screening and inclusion of the patient can be performed on the same day. On the day of the planned right heart catheterization based on clinical grounds, exercise right heart catheterisation (RHC) using Swan-Ganz and/or Conductance catheters with simultaneous echocardiography will be performed. End of study is defined as a complete exercise RHC. Adverse events will be assessed until 1 day after the exercise RHC. After placement of the Swan-ganz or Conductance catheter patients will undergo an exercise challenge using the following protocol in semi-supine position until exhaustion: * Incremental workload increase of 20Watt every 2-4 min. * For patients not able to start a 20 Watt, initial workload can be adjusted to a minimum of 5 Watt with 5 Watt increase every 2-4 min until exhaustion * Maximal exercise duration is 10-12 minutes * Symptoms of dyspnoea during exercise will be rated by subjects at baseline, after 6 minutes and at maximum according to the Borg perceived dyspnoea (0-10) scale. Simultaneously, echocardiography and lung ultrasound will be performed before exercise (baseline), after 6 minutes of exercise and at maximum. After assessment of right ventriclure pressure-volume loops during maximum exercise, guided by echocardiographic the conductance catheter will be placed in the right atrium to obtain right atrium pressure-volume loops during maximum exercise. Optional, the exercise RHC will be performed without the Conductance catheter and only with the Swan-Ganz catheter. In this case, pressure values and cardiac output will be measured using the thermodilution method, averaging 3-5 measurements at baseline, 6 minutes and maximum. Detailed assessment of right atrial pressure curves (with a and v wave) will be performed at baseline, 6 minutes and maximum exercise.

Interventions

OTHERExercise

After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Confirmed diagnosis of pulmonary arterial hypertension (World Health Organization group 1) * Pulmonary hypertension due to left heart disease (World Health Organization group 2) * Chronic thromboembolic pulmonary hypertension (World Health Organization group 4) * Invasive exclusion of pulmonary hypertension * Age ≥ 18 years * Planned right heart catheterization based on clinical grounds * Stable specific PAH medications * Ability to undergo cycle ergometry * Signed informed consent

Exclusion criteria

* Other etiologic groups of pulmonary hypertension (World Health Organization group 3, 5) * Unstable or severe coronary artery disease * Uncontrolled arterial hypertension * Left ventricular ejection fraction \< 30% * Severe congenital or acquired valvular or myocardial disease * Progressive left heart failure * History of severe ventricular arrhythmias * Severe, terminal renal impairment * Severe obstructive or restrictive lung disease * Severe lung emphysema or interstitial lung disease

Design outcomes

Primary

MeasureTime frameDescription
exercise right atrial volume-pressure curves1 dayatrial volume to pressure ratio (ml/mmHg)
exercise mean right atrial pressure1 daymean right atrial pressure (mmHg)
exercise right atrial function1 dayright atrial strain (%)
exercise right volume1 dayright ventricular volume (ml)
exercise right ventriculare function1 dayright ventricular strain (%)
exercise pulmonary arterial pressure1 daymean pulmonary arterial pressure (mmHg)
exercise cardiac output1 daycardiac output (l/min);
exercise pulmonary wedge pressure1 daypulmonary arterial wedge pressure (mmHg)
exercise arterial elastance1 dayarterial elastance (mmHg/mL)
exercise end-systolic elastance1 dayend-systolic elastance (mmHg/mL)

Secondary

MeasureTime frameDescription
exercise left atrial function1 dayleft atrial strain (%)
exercise left atrial volume1 dayleft atrial volume (ml)
exercise hepatic backflow1 daydiameter inferior vena cava (mm)
exercise lung congestion1 dayB-Lines

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026