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Clinical Trials/NCT04663217
NCT04663217
Completed
N/A

Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

University of Giessen2 sites in 1 country120 target enrollmentNovember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypertension, Pulmonary
Sponsor
University of Giessen
Enrollment
120
Locations
2
Primary Endpoint
exercise pulmonary arterial pressure
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
November 4, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

exercise pulmonary arterial pressure

Time Frame: 1 day

mean pulmonary arterial pressure (mmHg)

exercise cardiac output

Time Frame: 1 day

cardiac output (l/min);

exercise right ventriculare function

Time Frame: 1 day

right ventricular strain (%)

exercise end-systolic elastance

Time Frame: 1 day

end-systolic elastance (mmHg/mL)

exercise mean right atrial pressure

Time Frame: 1 day

mean right atrial pressure (mmHg)

exercise right atrial function

Time Frame: 1 day

right atrial strain (%)

exercise pulmonary wedge pressure

Time Frame: 1 day

pulmonary arterial wedge pressure (mmHg)

exercise right atrial volume-pressure curves

Time Frame: 1 day

atrial volume to pressure ratio (ml/mmHg)

exercise arterial elastance

Time Frame: 1 day

arterial elastance (mmHg/mL)

exercise right volume

Time Frame: 1 day

right ventricular volume (ml)

Secondary Outcomes

  • exercise left atrial function(1 day)
  • exercise lung congestion(1 day)
  • exercise left atrial volume(1 day)
  • exercise hepatic backflow(1 day)

Study Sites (2)

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