Exercise Hemodynamic Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension
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- STATUS
- Recruiting
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- days left to enroll
- 37
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- participants needed
- 120
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- sponsor
- University of Giessen
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.
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.
Details
| Condition | Primary Insulin Hypersecretion, Late Infantile Neuronal Ceroid Lipfuscinsosis, Complicated Grief, Dental Filling, Chronic Pelvic Pain, Nerve Injury, Infantile Fibrosarcoma, Pulmonary Arterial Hypertension, Pseudobulbar Affect, Memory Problems, Pelvic Adhesions, Low Testosterone, Catheter Complications, Open Heart Surgery, Functional Dyspepsia, Renal Anemia, Joint Injuries, Testotoxikose, Cancer Treatment, Myopic Macular Degeneration, Recurrent Pregnancy Loss, Surviving Abuse, Stasis Dermatitis, Serial Evaluation of Ductal Epithelium, Spine Athroplasty, Mental Disability, Severe Premenstrual Symptom, Chronic Renal Anemia, Gambling Problems, Effects of Chemotherapy, Indikation: Diabetes - Typ II, Pulmonary Hypertension, Partial Medial Meniscectomy, Abdominal Surgery, Habit Reversal, Anemic Cancer, Spinocerebellar Disorders, Hypertension, Pulmonary Arterial, Cancer Prevention |
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| Treatment | Exercise |
| Clinical Study Identifier | NCT04663217 |
| Sponsor | University of Giessen |
| Last Modified on | 14 November 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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