AnesthesiaPhase 2VANOPENCT07614438
Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery,
A Phase 2 study testing Vasopressin and Norepinephrine in people with Anesthesia and Pulmonary Hypertension, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Chronic thromboembolic pulmonary hypertension (CTEPH), one of the leading causes of pulmonary hypertension (PH), is caused by the chronic obstruction of the pulmonary arteries following episode of pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Pulmonary Hypertension, Chronic Pulmonary Thromboembolism
- What is being tested?
- Vasopressin and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2026to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Patient scheduled for pulmonary endarterectomy surgery;
- In women of childbearing potential: negative serum pregnancy test and use of adequate contraception;
- Affiliation to the French social care service;
- Patient able to understand and sign a written informed consent form.
Who cannot join
- Emergency surgery;
- Mesenteric ischemia and/or acute coronary syndrome within the month preceding the intervention;
- Patients with documented mesenteric artery stenosis;
- Impossibility to insert the pulmonary artery catheter (anatomical or technical issue);
- Preoperative administration of norepinephrine and/or inotropic drugs (dobutamine, isoproterenol, epinephrine) or patients assisted by veno-venous or veno-arterial ECMO before surgery;
- Known allergy to the active substance vasopressin or to any of its excipients;
Show all 13Show fewer
- Concomitant coronary bypass procedure or other combined surgery (i.e. valve replacement);
- mPAP<25 mmHg on preoperative right heart catheterization;
- Patient with preoperative natremia below 130 mol/L;
- Patient participating to another interventional clinical trial;
- For females only: documented pregnancy or lactation;
- Patient under tutorship, curatorship or legal protection;
- Patient deprived of liberty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery, a Randomized Open Label Trial
Chronic thromboembolic pulmonary hypertension (CTEPH), one of the leading causes of pulmonary hypertension (PH), is caused by the chronic obstruction of the pulmonary arteries following episode of pulmonary embolism. It is the only cause of PH which is accessible to a potential curative surgical treatment: the pulmonary endarterectomy (PEA). Because of their underlying disease (pulmonary hypertension and potential right heart dysfunction), anesthesia should be performed cautiously. Perioperative hemodynamic management often requires the administration of a vasopressor to maintain the arterial pressure above a specific threshold of 65 mmHg.
Low dose of vasopressin increases systemic arterial pressure with minimal effects on the pulmonary circulation. This profile suggests that vasopressin may be an ideal agent for vasopressor support in the high-risk population of patients with pulmonary hypertension.
Read more
To date, there is no data on the use of vasopressin in patient undergoing PEA surgery. The interesting properties of vasopressin - specifically, its ability to increase systemic arterial resistance while having a low impact on pulmonary resistance and offering potential renal protective effects - are highly advantageous in the specific subset of patient scheduled for PEA.
The investigators aim to conduct a randomized single center open label study to compare the effect of vasopressin compared to norepinephrine on mean pulmonary artery pressure after PEA surgery.
The primary objective of this study is to determine whether the use of vasopressin compared to norepinephrine decrease the mean pulmonary artery pressure after PEA surgery.
Participation to the study involves follow up at day 30 following surgery.
- Being tested
- Vasopressin, Norepinephrine
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
After inclusion and randomization, the intervention group will receive Vasopressin at a concentration of 0.04 IU/mL by continuous infusion (from 10 ml/h to 50 ml/h, by step of 3 ml/h) to target a MAP > 65 mmHg according to the protocol Vasopressin is continued for the first 24 hours in the intensive care unit following the same protocol.
NorepinephrineDrug
After inclusion and randomization, the control group will receive norepinephrine at a concentration of 16 μg/mL by continuous infusion (from 10 ml/h to 50 ml/h, by step of 3 ml/h) to target a MAP > 65 mmHg according to the protocol. Norepinephrine is continued for the first 24 hours in the intensive care unit following the same protocol.
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin | Experimental | Not described Receives: Drug: Vasopressin |
| Norepinephrine | Active comparator | Not described Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room.
Measured: at the end of skin closure immediately following the completion of the PEA procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion2 Aug 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614438
- Sponsor's protocol ID
- 2025-525153-39-00
- Other IDs
- 2025
- Acronym
- VANOPE
- Status last verified
- Mar 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vasopressin Versus Norepinephrine on Post-operative Mean Pulmonary Arterial Pressure Following Pulmonary Endarterectomy Surgery, a Randomized Open Label Trial
- ClinicalTrials.gov ID
- NCT07614438
- Acronym / sponsor ID
- VANOPE / 2025-525153-39-00
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 29 May 2026 (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.
Chronic thromboembolic pulmonary hypertension (CTEPH), one of the leading causes of pulmonary hypertension (PH), is caused by the chronic obstruction of the pulmonary arteries following episode of pulmonary embolism. It is the only cause of PH which is accessible to a potential curative surgical treatment: the pulmonary endarterectomy (PEA). Because of their underlying disease (pulmonary hypertension and potential right heart dysfunction), anesthesia should be performed cautiously. Perioperative hemodynamic management often requires the administration of a vasopressor to maintain the arterial pressure above a specific threshold of 65 mmHg.
Low dose of vasopressin increases systemic arterial pressure with minimal effects on the pulmonary circulation. This profile suggests that vasopressin may be an ideal agent for vasopressor support in the high-risk population of patients with pulmonary hypertension.
To date, there is no data on the use of vasopressin in patient undergoing PEA surgery. The interesting properties of vasopressin - specifically, its ability to increase systemic arterial resistance while having a low impact on pulmonary resistance and offering potential renal protective effects - are highly advantageous in the specific subset of patient scheduled for PEA.
The investigators aim to conduct a randomized single center open label study to compare the effect of vasopressin compared to norepinephrine on mean pulmonary artery pressure after PEA surgery.
The primary objective of this study is to determine whether the use of vasopressin compared to norepinephrine decrease the mean pulmonary artery pressure after PEA surgery.
Participation to the study involves follow up at day 30 following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressin | Experimental | Drug: Vasopressin |
| Norepinephrine | Active comparator | Drug: Norepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Patient scheduled for pulmonary endarterectomy surgery;
- In women of childbearing potential: negative serum pregnancy test and use of adequate contraception;
- Affiliation to the French social care service;
- Patient able to understand and sign a written informed consent form.
Key exclusion criteria (13 listed)
- Emergency surgery;
- Mesenteric ischemia and/or acute coronary syndrome within the month preceding the intervention;
- Patients with documented mesenteric artery stenosis;
- Impossibility to insert the pulmonary artery catheter (anatomical or technical issue);
- Preoperative administration of norepinephrine and/or inotropic drugs (dobutamine, isoproterenol, epinephrine) or patients assisted by veno-venous or veno-arterial ECMO before surgery;
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 |
|---|---|---|
| VasopressinAfter inclusion and randomization, the intervention group will receive Vasopressin at a concentration of 0.04 IU/mL by continuous infusion (from 10 ml/h to 50 ml/h, by step of 3 ml/h) to target a MAP > 65 mmHg according to the protocol Vasopressin is continued for the first 24 hours in the intensive care unit following the same protocol. | Drug | Vasopressin |
| NorepinephrineAfter inclusion and randomization, the control group will receive norepinephrine at a concentration of 16 μg/mL by continuous infusion (from 10 ml/h to 50 ml/h, by step of 3 ml/h) to target a MAP > 65 mmHg according to the protocol. Norepinephrine is continued for the first 24 hours in the intensive care unit following the same protocol. | Drug | Norepinephrine |
Primary outcome
mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room.
Time frame: at the end of skin closure immediately following the completion of the PEA procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vasopressin and Norepinephrine in people with Anesthesia and Pulmonary Hypertension, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
mPAP in millimeter of mercury (mmHg) measured by the Swan-Ganz catheter in the operating room. (time frame: at the end of skin closure immediately following the completion of the PEA procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.