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TX000045

Clinical trials are investigating TX000045 in people with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF). The main aim is to see whether TX000045 can improve blood flow resistance in the lungs and to assess safety. The study includes adults with PH-HFpEF and a baseline pulmonary vascular resistance of at least 3 Wood units.

Table of Contents

Trial overview

The available study of TX000045 is called the APEX Study and is designed for people with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF).[1] It is an interventional trial, which means researchers assign a study treatment and compare outcomes between groups.[1] The study is in Phase 2 and is authorised.[1]

Who can participate

The trial is for participants with pulmonary hypertension linked to HFpEF.[1] A key entry requirement is a baseline pulmonary vascular resistance (PVR) of at least 3 Wood units, which means the lung blood vessels must show a certain level of resistance at the start of the study.[1] The trial data do not list other eligibility details, so only this condition-based requirement can be confirmed here.[1]

What the study measures

The main endpoint is the mean change from baseline to Week 24 in PVR, measured by right heart catheterization (RHC), in participants with baseline PVR of at least 3 Wood units who receive TX000045 compared with those who receive placebo.[1] This tells researchers whether TX000045 changes how much resistance blood meets in the lung circulation over time.[1]

The study also measures safety outcomes, including the number of adverse events, adverse events of special interest, and serious adverse events in people who receive TX000045 compared with placebo.[1] In addition, researchers are watching for clinically significant changes in laboratory tests, 12-lead electrocardiogram (ECG), vital signs, and physical examinations.[1]

Study design and treatment groups

The study compares TX000045 with a sterile isotonic solution, which is the placebo used in this trial.[1] The listed TX000045 dose is 300 mg given by subcutaneous administration, meaning under the skin.[1] The brief summary says the study is evaluating the effect of TX000045 versus placebo on mean PVR and also assessing safety in PH-HFpEF.[1]

Study status and size

The trial has an enrollment target of 255 participants.[1] Its current status is authorised.[1] The study duration is 24 weeks, and the main outcome is assessed at Week 24.[1]

Trial ID Phase Condition studied Status Enrollment
2024-514283-40-00 Phase 2 Pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF) Authorised 255

FAQ

  • What is being studied in TX000045 clinical trials? The trial is studying whether TX000045 can improve pulmonary vascular resistance, which is a measure of how hard it is for blood to flow through the lung vessels. It is also checking safety in people with PH-HFpEF.
  • Who can take part in the study? The study is for participants with pulmonary hypertension secondary to heart failure with preserved ejection fraction. People must have a baseline pulmonary vascular resistance of at least 3 Wood units.
  • What phase is the TX000045 trial? This is a Phase 2 trial. Phase 2 studies usually look at whether a treatment shows early signs of benefit and continue to check safety.
  • How long does the study last? The study lasts 24 weeks. The main outcome is measured at Week 24.
  • What results are the researchers measuring? Researchers are measuring the change in pulmonary vascular resistance from the start of the study to Week 24. They are also tracking side effects, serious side effects, and changes in lab tests, ECG, vital signs, and physical exams.

Ongoing Clinical Trials on TX000045

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

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Germany Latvia Poland +3

Glossary

  • Pulmonary hypertension: High blood pressure in the blood vessels of the lungs.
  • Heart failure with preserved ejection fraction (HFpEF): A type of heart failure where the heart still pumps out a normal-looking amount of blood, but it does not relax and fill well.
  • PH-HFpEF: Pulmonary hypertension that happens because of heart failure with preserved ejection fraction.
  • Phase 2: A study stage that looks at early signs that a treatment may work and keeps checking safety.
  • Interventional study: A study where researchers give a treatment and compare results with another group.
  • Placebo: A look-alike treatment that does not contain the active study drug.
  • Pulmonary vascular resistance (PVR): A measure of how much resistance blood meets when it flows through the lung vessels.
  • Right heart catheterization (RHC): A test where a thin tube is placed into the right side of the heart to measure pressures and blood flow.
  • Wood unit: A unit used to measure resistance in the lung blood vessels.
  • Adverse event (AE): Any unwanted medical problem that happens during a study.
  • Serious adverse event (SAE): A serious unwanted medical problem, such as one that is life-threatening or needs hospital care.
  • Electrocardiogram (ECG): A test that records the electrical activity of the heart.

References

  1. https://clinicaltrials.gov/study/2024-514283-40-00