Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04663217
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Giessen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Richter J Manuel, MD
Principal Investigator Affiliation	UKGM Giessen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hypertension, Pulmonary, Hypertension, Pulmonary Arterial

Additional Details

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.

Arms & Interventions

Arms

: Pulmonary arterial hypertension

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.

: Pulmonary hypertension due to left heart disease

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.

: Chronic thromboembolic pulmonary hypertension

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.

: Control

Patients with mean pulmonary arterial pressure below 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with exclusion of pulmonary hypertension.

Interventions

Other: - Exercise

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

Contact a Trial Team

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