Study of TX000045 for Pulmonary Hypertension in Heart Failure Patients with Preserved Ejection Fraction

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What is this study about?

This clinical trial is focused on studying a condition known as Pulmonary Hypertension, which occurs when there is high blood pressure in the blood vessels that supply the lungs. Specifically, the study is looking at a type of pulmonary hypertension that happens in people who have Heart Failure with Preserved Ejection Fraction (HFpEF). This means that the heart’s ability to pump blood is normal, but the heart is stiff and doesn’t fill with blood as well as it should. The treatment being tested in this study is a medication called TX000045, which is given as a solution for injection or infusion. The study will compare the effects of TX000045 with a placebo to see how well it works and how safe it is for patients with this condition.

The purpose of the study is to evaluate the effect of TX000045 on the blood flow resistance in the lungs, known as Pulmonary Vascular Resistance (PVR), and to assess the safety of the medication. Participants in the study will receive either TX000045 or a placebo for a period of 24 weeks. During this time, they will have regular check-ups and tests to monitor their health and the effects of the treatment. These tests will include measuring PVR using a procedure called right heart catheterization (RHC), which involves inserting a thin tube into the heart to measure pressure and blood flow.

Throughout the study, participants will also undergo a 6-minute walk test (6MWT), which measures how far they can walk in six minutes, to assess their physical capacity. The study aims to see if there are any changes in the participants’ ability to walk and in their heart and lung function after receiving the treatment. The safety of TX000045 will be closely monitored by checking for any side effects or changes in health through regular laboratory tests, heart monitoring with an electrocardiogram (ECG), and physical examinations. The study is designed to provide valuable information about the potential benefits and risks of TX000045 for patients with pulmonary hypertension related to heart failure with preserved ejection fraction.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments may include a review of your medical history, a physical examination, and specific tests such as an echocardiogram and a right heart catheterization (RHC).

The echocardiogram is a test that uses sound waves to create images of your heart, helping to assess its function and structure. The RHC is a procedure that measures the pressure in your heart and lungs.

2 randomization

After the initial assessments, you will be randomly assigned to one of two groups. One group will receive the investigational medication TX000045, and the other group will receive a placebo, which is a substance with no active medication.

This process is double-blind, meaning neither you nor the study team will know which group you are in. This helps ensure the results are unbiased.

3 treatment phase

During the treatment phase, you will receive the assigned medication through a subcutaneous injection. This means the medication is injected under the skin.

The treatment will last for a total of 24 weeks. You will receive the medication at regular intervals as specified by the study protocol.

4 follow-up visits

Throughout the 24-week treatment period, you will have regular follow-up visits with the study team. These visits are important to monitor your health and the effects of the treatment.

During these visits, you may undergo various tests, including blood tests, electrocardiograms (ECGs), and physical examinations. These tests help ensure your safety and assess the effectiveness of the treatment.

5 final assessment

At the end of the 24-week treatment period, you will have a final assessment. This will include a comprehensive evaluation similar to the initial visit, with tests such as an echocardiogram and a right heart catheterization.

The purpose of this final assessment is to measure any changes in your condition and to gather data on the safety and efficacy of the treatment.

Who Can Join the Study?

Must be a male or female who cannot have children, aged between 18 and 80 years. For women, this means either being in a postmenopausal state (no periods for 12 months and a specific hormone level) or having had certain surgeries like removal of the uterus or ovaries.
Must have a diagnosis of Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction (PH-HFpEF). This includes specific heart measurements from tests like echocardiograms and right heart catheterization.
Must have NYHA functional class II-III heart failure, which describes the severity of heart failure symptoms.
Must be able to walk a distance between 100 meters and 450 meters in a test called the 6-Minute Walk Test (6MWT), with consistent results during screening.
Must have been on stable medication for heart failure or cardiovascular disease for at least 30 days before screening. Some medications like GLP-1 agonists need to be stable for at least 180 days. Diuretics and anticoagulants have specific rules but should not be newly started or stopped close to screening.
Must be able to attend all study visits and follow the study requirements.
Must agree not to participate in any other studies involving experimental drugs or devices while in this study.
Must be able to understand and sign a consent form to participate in the study.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a heart attack or stroke in the last 6 months.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse in the past year.
Patients who have had an organ transplant.
Patients with uncontrolled high blood pressure.
Patients who are allergic to the study medication or its ingredients.
Patients with a history of cancer in the past 5 years, except for certain skin cancers.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Sana-Klinikum Remscheid GmbH	Remscheid	Germany
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Spitalul Clinic Judetean De Urgenta Craiova	Craiova	Romania
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD	Sofia	Bulgaria
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu	Bucharest	Romania
Hospital 9 De Octubre S.A.	Valencia	Spain
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Ziekenhuis Oost Limburg	Genk	Belgium
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Emergency Institute For Cardiovascular Diseases And Transplant	Targu Mures	Romania
Hospital Costa del Sol	Marbella	Spain
Klinik Favoriten 5. Medizinische Abteilung mit Kardiologie	Vienna	Austria
Urgsqrsxmt Mlzeora Cbicnd Hjbhrmujkwozbyefl	Hamburg	Germany
Duezdriwac Cvwnqidxldya Cqtvds (qhps &ltkcopxjhwx Ayokjtlwapt Eyis	Sofia	Bulgaria
Hmiycbbh Vfsc dmripoob	Barcelona	Spain
Kvpifzvym Skvryxe Sqleneikdxoptut is Jsqx Popuj Ig	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	05.08.2024
Belgium	Not recruiting	05.08.2024
Bulgaria	Not recruiting	05.08.2024
Germany	Not recruiting	05.08.2024
Latvia	Not recruiting	05.08.2024
Poland	Not recruiting	05.08.2024
Portugal	Not recruiting	05.08.2024
Romania	Not recruiting	05.08.2024
Spain	Not recruiting	05.08.2024

Trial locations

Investigated drugs:

TX000045

TX000045 is a medication being studied for its potential to help people with a specific type of high blood pressure that affects the lungs, known as pulmonary hypertension. This condition is linked to heart failure where the heart’s pumping ability is normal, but the heart still struggles to fill with blood properly. The goal of using TX000045 in this study is to see if it can lower the pressure in the blood vessels of the lungs, which might help improve symptoms and make it easier for patients to breathe and be active. The study also aims to ensure that TX000045 is safe for patients to use.

Investigated diseases:

Pulmonary hypertension

Pulmonary Hypertension – Pulmonary Hypertension is a condition characterized by high blood pressure in the arteries of the lungs. This disease causes the blood vessels in the lungs to become narrowed, blocked, or destroyed, leading to increased resistance to blood flow. As a result, the heart must work harder to pump blood through the lungs, which can lead to heart strain and enlargement. Over time, the increased workload on the heart can cause symptoms such as shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can vary, with symptoms gradually worsening as the condition advances. Pulmonary Hypertension can occur on its own or as a complication of other diseases affecting the heart and lungs.

Trial ID:

2024-514283-40-00

Protocol code:

TX000045-003

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of TX000045 for Pulmonary Hypertension in Heart Failure Patients with Preserved Ejection Fraction

What is this study about?

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