Study of AZD3427 for Patients with Heart Failure and Pulmonary Hypertension from Left Heart Disease

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called AZD3427 for people with Heart Failure and Pulmonary Hypertension due to Left Heart Disease. Heart failure is a condition where the heart doesn’t pump blood as well as it should, and pulmonary hypertension is high blood pressure in the blood vessels that supply the lungs. The purpose of the study is to evaluate how AZD3427, which is given as a solution for injection under the skin, affects the blood flow in the lungs after 24 weeks of treatment.

Participants in the study will be randomly assigned to receive either AZD3427 or a placebo, which looks like the treatment but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations. The study will take place over several months, with regular check-ups to monitor the participants’ health and the effects of the treatment.

The main goal is to see if AZD3427 can improve the condition of the blood vessels in the lungs, which is measured by a test called right heart catheterization. This test helps doctors see how well the heart and lungs are working together. The study will also look at other health indicators, such as heart function and exercise capacity, to understand the overall impact of the treatment. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age, medical history, and current health status.

You will be required to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.

2 screening visits

You will undergo two screening visits. The first screening visit will involve assessments to confirm your diagnosis of heart failure and pulmonary hypertension.

The second screening visit will include a procedure called right heart catheterization (RHC) to measure the pressure in your pulmonary artery. This will help determine if you meet the study’s requirements.

3 randomization

If you qualify, you will be randomly assigned to receive either the study medication, AZD3427, or a placebo. A placebo is a substance with no active medication, used for comparison.

This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 treatment phase

You will receive the assigned treatment as a subcutaneous injection, which means it is administered under the skin. The treatment will be given regularly over a period of 24 weeks.

The dosage and frequency of the injections will be determined by the study protocol and will be explained to you by the study team.

5 follow-up visits

Throughout the treatment phase, you will have regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment.

During these visits, various tests and assessments will be conducted, including measurements of heart function and blood tests.

6 end of treatment

After 24 weeks of treatment, you will have a final assessment to evaluate the effects of the medication on your condition.

This will include another right heart catheterization to measure changes in your pulmonary artery pressure.

7 post-study follow-up

You may be asked to attend additional follow-up visits after the treatment phase to monitor your health and gather further data for the study.

These visits are important for ensuring your well-being and for the study’s overall analysis.

Who Can Join the Study?

Participant must be at least 18 years old at the time of signing the informed consent.
Participants must have a pre-existing diagnosis of Heart Failure (HF) and Pulmonary Hypertension due to Left Heart Disease (PH-LHD). They should be on stable heart failure medication, including diuretics, for at least 4 weeks before the first screening visit.
Participants must show certain heart-related measurements at the first screening visit that indicate a medium or high chance of having pulmonary hypertension.
Participants must have high blood pressure in the lungs, confirmed by a test called Right Heart Catheterization (RHC) at the second screening visit. This includes:
- PAWP (Pulmonary Artery Wedge Pressure) of 15 mmHg or higher
- mPAP (mean Pulmonary Artery Pressure) of 20 mmHg or higher
Minimum body weight of 45 kg (about 99 pounds).
Female participants must not be pregnant or breastfeeding and must be unable to have children, confirmed by one of the following:
- Being postmenopausal, which means having no menstrual periods for at least 12 months after stopping all hormone treatments, with certain hormone levels in the postmenopausal range.
- Having had surgery that permanently prevents pregnancy, such as removal of the uterus (hysterectomy), both ovaries (bilateral oophorectomy), or both fallopian tubes (bilateral salpingectomy). Note: Tubal ligation is not considered permanent.
Non-sterilized male participants should use a condom during all sexual intercourse with a female partner who can have children, from the first dose until 3 months after the last dose. They should also avoid fathering a child or donating sperm for 3 months after the last dose.
Participants must be able and willing to give signed informed consent, agreeing to follow the study requirements and restrictions.
Participants must provide signed and dated consent for optional genetic research before any samples are collected for this purpose.

Who Cannot Join the Study?

Patients with other types of heart diseases not related to the study.
Patients with severe lung diseases not related to the study.
Patients who have had a heart attack in the last 3 months.
Patients with uncontrolled high blood pressure.
Patients with severe kidney problems.
Patients with severe liver problems.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients who have had an organ transplant.
Patients with a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
University Hospital Jena KöR	Jena	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Klinik Favoriten	Vienna	Austria
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Deventer Ziekenhuis	Deventer	The Netherlands
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Krankenhaus Der Barmherzigen Bruder Eisenstadt GmbH	Eisenstadt	Austria
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Karolinska University Hospital	Solna	Sweden
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Region Midtjylland	Aarhus	Denmark
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Rigshospitalet	Copenhagen	Denmark
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Universita Degli Studi Di Brescia	Brescia	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Elisabeth-Tweesteden Ziekenhuis	Tilburg	The Netherlands
Cmwjddwnk Hjwfdbnu	Trieste	Italy
Uctnhxpqyf Hortdlbb Ccaufdc	Cologne	Germany
Ufyfytt Unvlwrgaas Hbcrowak	Uppsala	Sweden
Gnqygf Uozhuevkur Fhjptuulv	Frankfurt	Germany
Uumwomjirzugeh Cwcxvjx Kdudddwje	Gdansk	Poland
Oyjzfntejfgkjd Lpks Gqpo	Linz	Austria
Ialnmjouy Ffi Cyzsuono Adc Eqhnrxsvomze Mbupuvdn	Prague	Czechia
Kbtkcwcqp Suaftvo Siadxxvpfszogwt id Jsxg Pmixz Iw	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	21.07.2023
Czechia	Not recruiting	21.07.2023
Denmark	Not recruiting	21.07.2023
Germany	Not recruiting	21.07.2023
Italy	Not recruiting	21.07.2023
Poland	Not recruiting	21.07.2023
Spain	Not recruiting	21.07.2023
Sweden	Not recruiting	21.07.2023
The Netherlands	Not recruiting	21.07.2023

Trial locations

Investigated drugs:

Azd3427

AZD3427 is a medication being studied for its potential to help people with heart failure and pulmonary hypertension, which is a type of high blood pressure that affects the lungs and heart. This medication is being tested to see if it can lower the pressure in the blood vessels of the lungs, which might help the heart work better and improve symptoms for people with these conditions. The study is looking at how well this medication works over a period of 24 weeks.

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body’s needs. It often begins with the heart’s inability to fill with enough blood or pump with enough force. Over time, this can lead to fluid buildup in the lungs and other parts of the body, causing symptoms like shortness of breath and swelling. The condition can progress gradually, with worsening symptoms and reduced physical activity. It can affect one or both sides of the heart, leading to different types of heart failure. The progression can vary, with periods of stability and episodes of worsening symptoms.

Pulmonary Hypertension due to Left Heart Disease (WHO Group 2) – Pulmonary hypertension due to left heart disease is a condition where high blood pressure occurs in the blood vessels of the lungs due to problems with the left side of the heart. This can happen when the left heart is unable to pump blood efficiently, causing a backup of blood into the lungs. Over time, the increased pressure can damage the blood vessels in the lungs, leading to further complications. Symptoms may include shortness of breath, fatigue, and chest pain. The condition can progress as the heart and lung pressures continue to rise. It is often associated with other heart conditions, such as heart failure or valve disease.

Trial ID:

2022-502382-25-00

Protocol code:

D8330C00003

NCT ID:

NCT05737940

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of AZD3427 for Patients with Heart Failure and Pulmonary Hypertension from Left Heart Disease

What is this study about?

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