Not yet recruitingRare disease

Vasopressin Versus Norepinephrine for Patients with Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Endarterectomy Surgery

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in people with Chronic thromboembolic pulmonary hypertension, a form of high blood pressure in the lungs caused by old blood clots. The study compares two medicines given by intravenous infusion after pulmonary endarterectomy, an operation that removes clots from the lung arteries. The medicines are argipressin in Reverpleg 40 U.I./2 ml and noradrenaline tartrate in NORADRENALINE VIATRIS 2 mg/ml SANS SULFITES. The purpose of the study is to see which medicine works better for lowering pressure in the lung arteries soon after surgery.

After the operation, each person receives one of the two medicines through a vein. The treatment is given in the recovery period after surgery, and the medical team follows the person during the hospital stay to watch how the heart, lungs, kidneys, and other organs recover. The study is open label, which means the treatment is known to the medical team and the person receiving it.

The main outcome is the change in mean pulmonary arterial pressure, which is the pressure in the main blood vessel carrying blood from the heart to the lungs. Other hospital problems may also be watched, such as kidney failure, atrial fibrillation or atrial flutter (irregular heart rhythms), stroke, pneumonia, bleeding from the airways, and death. The study is planned to run over several years while enough people are enrolled and followed after surgery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study treatment begins
After you join the study, you receive one of two study medicines through an intravenous infusion (medicine given directly into a vein). The study compares argipressin with noradrenaline tartrate.
If you receive argipressin, the dose is 47.52 iu. If you receive noradrenaline tartrate, the dose is 240 mg.
Both medicines are given by intravenous infusion. The source data do not give a frequency or total duration for administration.
Step 2
During and immediately after surgery
Your mean pulmonary arterial pressure (mPAP, the pressure in the artery that carries blood from the heart to the lungs) is measured in the operating room with a Swan-ganz catheter (a thin tube used to measure blood flow and pressure in the heart and lungs).
The main measurement is recorded at the end of skin closure, right after the pulmonary endarterectomy (pea, surgery to remove clots and scar tissue from the lung arteries) is finished.
Other measurements may also be taken with the Swan-ganz catheter, including vascular pulmonary resistance (how hard it is for blood to flow through the lung vessels), cardiac output (the amount of blood the heart pumps each minute), and pulmonary artery compliance (how flexible the lung artery is).
Step 3
First hospital and intensive care unit period
Your progress is followed for problems that may happen after surgery, including the need for extra support to help the heart and blood circulation, the need for kidney treatment, irregular heart rhythm such as atrial fibrillation or atrial flutter, bleeding in the airways, breathing problems, heart attack, bowel blood flow problems, stroke, confusion, seizures, and infection at the surgical site.
The study also checks whether you need to return to the intensive care unit because of breathing failure or need for breathing support, and whether you need to stay on a breathing machine, sedatives, muscle relaxants, inhaled no (nitric oxide, a gas used to help blood flow in the lungs), or prone positioning (lying on the stomach).
The length of your stay in the intensive care unit and in the hospital is recorded in days from admission until discharge.
Step 4
First 30 days after surgery
Any surgical reintervention of the surgical site during the first 30 days after surgery is recorded.
Death from any cause is also recorded during the study follow-up.

Who can join the trial?

5 criteria

Be 18 years of age or older.
Be scheduled to have pulmonary endarterectomy surgery, which is an operation to remove material blocking the lung arteries.
For women who can become pregnant: have a negative blood pregnancy test before the study and use adequate contraception, meaning a reliable method to prevent pregnancy.
Be affiliated with the French social care service.
Be able to understand the study information and sign a written informed consent form, which is a document showing that the person agrees to take part after receiving the explanation.

Who cannot join the trial?

10 criteria

Emergency surgery is required.
The patient had mesenteric ischemia within the last month before the procedure. Mesenteric ischemia means too little blood flow to the intestines.
The patient had an acute coronary syndrome within the last month before the procedure. This means a sudden serious heart problem, such as a heart attack or unstable chest pain.
The patient has a known allergy to vasopressin or to any of its excipients (the inactive ingredients in the medicine).
The patient needs a coronary bypass or another combined surgery, such as valve replacement.
The patient’s mean pulmonary arterial pressure (mPAP) was below 25 mmHg before surgery on right heart catheterization. Right heart catheterization is a test where a thin tube is placed into the right side of the heart to measure pressures.
The patient is taking part in another interventional clinical trial, meaning another research study that gives a treatment or procedure.
For females only: the patient is pregnant or breastfeeding (lactation).
The patient is under tutorship, curatorship, or other legal protection, meaning another person or legal system makes decisions for them.
The patient is deprived of liberty, meaning they are not free to leave, such as being in prison or in custody.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Paris, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Norepinephrine
is a medicine given through a vein to help raise and support blood pressure. In this trial, it is used as the comparison treatment after surgery to see how well it lowers mean pulmonary artery pressure compared with the study medicine.
Vasopressin
is a medicine given through a vein that helps tighten blood vessels and support blood pressure. In this trial, it is the study treatment being tested to see whether it works better than norepinephrine for lowering mean pulmonary artery pressure right after pulmonary endarterectomy surgery.

What is already known about the treatment

Noradrenaline tartrate
Noradrenaline tartrate is given by intravenous infusion, which means it is delivered slowly into a vein in a hospital setting. It is a well-known medicine in current medical practice and is widely described in medical literature as a strong vasopressor, a drug that raises blood pressure. It is mainly used to treat very low blood pressure and shock, and it works by stimulating alpha-1 and beta-1 receptors, which makes blood vessels tighten and helps the heart pump more strongly.
Argipressin
Argipressin is given by intravenous infusion, so it is administered directly into a vein under close medical supervision. It is an established medicine in current practice and medical literature, and it is a synthetic form of vasopressin, a hormone used as a vasopressor. It is mainly used to raise blood pressure in severe low-blood-pressure states, and it works by acting on vasopressin receptors in blood vessels, causing them to narrow and reducing water loss by the kidneys.

Investigated diseases

Chronic thromboembolic pulmonary hypertension - A form of pulmonary hypertension caused by long-lasting blood clots that remain in the lung arteries and narrow or block blood flow. It develops gradually as these clots become organized and scar-like, which increases pressure in the lung circulation. Over time, the right side of the heart must work harder to push blood through the lungs, and the strain can slowly worsen.