Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

NCT ID: NCT04663217

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-11-04

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.

Conditions

Hypertension, Pulmonary; Hypertension, Pulmonary Arterial

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Exercise

Intervention Type: OTHER

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

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.

Exercise

Intervention Type: OTHER

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

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.

Exercise

Intervention Type: OTHER

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

Control

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

Exercise

Intervention Type: OTHER

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

Interventions

Exercise

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richter J Manuel, MD

Role: PRINCIPAL_INVESTIGATOR

UKGM Giessen

Locations

Kerckhoff-Klinik

Bad Nauheim, Hesse, Germany

University of Giessen

Giessen, Hesse, Germany

Countries

Germany

References

Yogeswaran A, da Rocha BB, Rako ZA, Kaufmann SJ, Schafer S, Kremer N, Ghofrani HA, Seeger W, Tello K. Physiological mechanisms behind respiratory variations in right atrial pressure in pulmonary hypertension. Sci Rep. 2024 May 31;14(1):12547. doi: 10.1038/s41598-024-61825-6.

Reference Type: DERIVED

PMID: 38822042 (View on PubMed)

Rako ZA, Yogeswaran A, Lakatos BK, Fabian A, Yildiz S, da Rocha BB, Vadasz I, Ghofrani HA, Seeger W, Gall H, Kremer NC, Richter MJ, Bauer P, Tedford RJ, Naeije R, Kovacs A, Tello K. Clinical and functional relevance of right ventricular contraction patterns in pulmonary hypertension. J Heart Lung Transplant. 2023 Nov;42(11):1518-1528. doi: 10.1016/j.healun.2023.07.004. Epub 2023 Jul 13.

Reference Type: DERIVED

PMID: 37451352 (View on PubMed)

Other Identifiers

AZ 11716

Identifier Type: -

Identifier Source: org_study_id