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

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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

TX000045 – TX000045 is administered orally in the form of tablets and is currently being studied in clinical trials for its potential use in treating pulmonary hypertension, specifically in patients with heart failure with preserved ejection fraction (PH-HFpEF). This medication is still under investigation, and its effects and safety are being evaluated in medical research. The main therapeutic indication for TX000045 is to help reduce the pressure in the blood vessels of the lungs, which can improve heart function and symptoms in affected patients. At the molecular level, TX000045 works by relaxing and widening the blood vessels in the lungs, which helps to lower the blood pressure in these vessels. It is classified pharmacologically as a vasodilator, which means it helps to open up blood vessels to improve blood flow.

Investigated diseases

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 detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514283-40-00Protocol codeTX000045-003Estimated enrolment311 patientsSponsorTectonic Therapeutic Inc.

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