Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

Conditions
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Hypertension, Pulmonary, Hypertension, Pulmonary Arterial

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary arterial hypertension<br>Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg classified into group 1 of the clinical classification of pulmonary hypertension. | Other: Exercise<br>* After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion<br>|
| Pulmonary hypertension due to left heart disease<br>Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure above 15 mmHg with left heart disease, classified into group 2 of the clinical classification of pulmonary hypertension. | Other: Exercise<br>* After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion<br>|
| Chronic thromboembolic pulmonary hypertension<br>Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with a history of pulmonary embolism, classified into group 4 of the clinical classification of pulmonary hypertension. | Other: Exercise<br>* After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion<br>|
| Control<br>Patients with mean pulmonary arterial pressure below 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with exclusion of pulmonary hypertension. | Other: Exercise<br>* After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise pulmonary arterial pressure | mean pulmonary arterial pressure (mmHg) | 1 day | 
| exercise cardiac output | cardiac output (l/min); | 1 day | 
| exercise pulmonary wedge pressure | pulmonary arterial wedge pressure (mmHg) | 1 day | 
| exercise arterial elastance | arterial elastance (mmHg/mL) | 1 day | 
| exercise end-systolic elastance | end-systolic elastance (mmHg/mL) | 1 day | 
| exercise mean right atrial pressure | mean right atrial pressure (mmHg) | 1 day | 
| exercise right atrial function | right atrial strain (%) | 1 day | 
| exercise right volume | right ventricular volume (ml) | 1 day | 
| exercise right ventriculare function | right ventricular strain (%) | 1 day | 
| exercise right atrial volume-pressure curves | atrial volume to pressure ratio (ml/mmHg) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise lung congestion | B-Lines | 1 day | 
| exercise left atrial function | left atrial strain (%) | 1 day | 
| exercise left atrial volume | left atrial volume (ml) | 1 day | 
| exercise hepatic backflow | diameter inferior vena cava (mm) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, Hypertension, Pulmonary