Hypertension, PulmonaryEXERTIONNCT04663217
Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension
An observational study of Hypertension, Pulmonary and Hypertension, Pulmonary Arterial, run by University of Giessen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pulmonary, Hypertension, Pulmonary Arterial
- What is being tested?
- Exercise
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Nov 2020to 4 Nov 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Confirmed diagnosis of either pulmonary arterial hypertension; pulmonary hypertension due to left heat disease; chronic thromboembolic pulmonary hypertension; or invasive exclusion of pulmonary hypertension (control group)
Who may be able to join
- 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
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- Stable specific PAH medications
- Ability to undergo cycle ergometry
- Signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- History of severe ventricular arrhythmias
- Severe, terminal renal impairment
- Severe obstructive or restrictive lung disease
- Severe lung emphysema or interstitial lung disease
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kerckhoff-Klinik
Bad Nauheim, Hesse
University of Giessen
Giessen, Hesse, 35390
About this study
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.
Read the 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.
- Being tested
- Exercise
- Keywords
- exercise, Hypertension, Pulmonary
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise | |
| 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. Receives: Other: Exercise | |
| 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. Receives: Other: Exercise | |
| Control | Patients with mean pulmonary arterial pressure below 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with exclusion of pulmonary hypertension. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise pulmonary arterial pressure
mean pulmonary arterial pressure (mmHg)
Measured: 1 day
exercise cardiac output
cardiac output (l/min);
Measured: 1 day
exercise pulmonary wedge pressure
pulmonary arterial wedge pressure (mmHg)
Measured: 1 day
exercise arterial elastance
arterial elastance (mmHg/mL)
Measured: 1 day
exercise end-systolic elastance
end-systolic elastance (mmHg/mL)
Measured: 1 day
exercise mean right atrial pressure
mean right atrial pressure (mmHg)
Measured: 1 day
exercise right atrial function
right atrial strain (%)
Measured: 1 day
exercise right volume
right ventricular volume (ml)
Measured: 1 day
exercise right ventriculare function
right ventricular strain (%)
Measured: 1 day
exercise right atrial volume-pressure curves
atrial volume to pressure ratio (ml/mmHg)
Measured: 1 day
Secondary outcomes (4)
exercise lung congestion
B-Lines
Measured: 1 day
exercise left atrial function
left atrial strain (%)
Measured: 1 day
exercise left atrial volume
left atrial volume (ml)
Measured: 1 day
exercise hepatic backflow
diameter inferior vena cava (mm)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Nov 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richter J Manuel, MD, Principal investigator, UKGM Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663217
- Sponsor's protocol ID
- AZ 11716
- Acronym
- EXERTION
- Status last verified
- May 2024
- First submitted
- 5 Nov 2020
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon request.
Publications
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.
PubMed 38822042Rako 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.
PubMed 37451352Richter MJ, Douschan P, Fortuni F, Gall H, Ghofrani HA, Keranov S, Kremer N, Kriechbaum SD, Rako ZA, Rieth AJ, da Rocha BB, Seeger W, Zedler D, Yildiz S, Yogeswaran A, Tello K. Echocardiographic pressure-strain loop-derived stroke work of the right ventricle: validation against the gold standard. ESC Heart Fail. 2023 Oct;10(5):3209-3215. doi: 10.1002/ehf2.14453. Epub 2023 Jul 6.
PubMed 37415381
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04663217
- Acronym / sponsor ID
- EXERTION / AZ 11716
- Keywords
- exercise, Hypertension, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | Other: ExercisePatients 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 | – | Other: ExercisePatients 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 | – | Other: ExercisePatients 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 | – | Other: ExercisePatients with mean pulmonary arterial pressure below 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with exclusion of pulmonary hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed diagnosis of either pulmonary arterial hypertension; pulmonary hypertension due to left heat disease; chronic thromboembolic pulmonary hypertension; or invasive exclusion of pulmonary hypertension (control group)
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAfter placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion | Other | Chronic thromboembolic pulmonary hypertension, Control, Pulmonary arterial hypertension, Pulmonary hypertension due to left heart disease |
Primary outcome
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 pulmonary wedge pressure
Time frame: 1 day
pulmonary arterial wedge pressure (mmHg)
exercise arterial elastance
Time frame: 1 day
arterial elastance (mmHg/mL)
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 right volume
Time frame: 1 day
right ventricular volume (ml)
exercise right ventriculare function
Time frame: 1 day
right ventricular strain (%)
exercise right atrial volume-pressure curves
Time frame: 1 day
atrial volume to pressure ratio (ml/mmHg)
4 secondary outcomes
exercise lung congestion
Time frame: 1 day
exercise left atrial function
Time frame: 1 day
exercise left atrial volume
Time frame: 1 day
exercise hepatic backflow
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 38822042Yogeswaran 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.
- Derived from this study: PubMed 37451352Rako 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.
- Derived from this study: PubMed 37415381Richter MJ, Douschan P, Fortuni F, Gall H, Ghofrani HA, Keranov S, Kremer N, Kriechbaum SD, Rako ZA, Rieth AJ, da Rocha BB, Seeger W, Zedler D, Yildiz S, Yogeswaran A, Tello K. Echocardiographic pressure-strain loop-derived stroke work of the right ventricle: validation against the gold standard. ESC Heart Fail. 2023 Oct;10(5):3209-3215. doi: 10.1002/ehf2.14453. Epub 2023 Jul 6.
- Individual participant dataSharing planned: Undecided. Data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richter J Manuel, MD principal investigator
UKGM Giessen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary and Hypertension, Pulmonary Arterial, run by University of Giessen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise pulmonary arterial pressure (time frame: 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663217, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.