Study of the effectiveness of a new drug in the treatment of heart failure and pulmonary hypertension

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    What is this study about?

    This clinical trial explores the potential benefits of AZD3427 for individuals with heart failure (HF) and pulmonary hypertension (PH) Group 2, a condition characterized by increased blood pressure in the lungs due to heart disease. Around 220 participants will be randomly assigned to receive either AZD3427 or a placebo through subcutaneous injections every two weeks for 24 weeks. The trial aims to assess the impact of AZD3427 on reducing pulmonary vascular resistance (PVR) and improving various heart and lung health indicators. Participants will undergo multiple study visits, with the total duration of the study being approximately 32 to 37 weeks.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Eisenstadt , Austria

      Linz , Austria

      Wien , Austria

      Praha 10 , Czechia

      Praha 2 , Czechia

      Praha 4 , Czechia

      Aarhus , Denmark

      Copenhagen , Denmark

      Berlin , Germany

      Cologne , Germany

      Frankfurt , Germany

      Jena , Germany

      Brescia , Italy

      Genoa , Italy

      Marche , Italy

      Milano , Italy

      Milan , Italy

      Trieste , Italy

      Deventer , Netherlands

      Heerlen , Netherlands

      Tilburg , Netherlands

      Biau0142ystok , Poland

      Gdansk , Poland

      Krakow , Poland

      Warszawa , Poland

      Warszawa , Poland

      Wrocu0142aw , Poland

      Majadahonda , Spain

      Sevilla , Spain

      Toledo , Spain

      Valencia , Spain

      Gu00f6teborg , Sweden

      Huddinge , Sweden

      Cambridge , United Kingdom

      Clydebank , United Kingdom

      London , United Kingdom

      You can join this study in:

      Denmark: Aarhus, Copenhagen.

      Germany: Berlin, Cologne, Frankfurt, Jena.

      Italy: Brescia, Genoa, Milan, Trieste.

      United Kingdom: Cambridge, Clydebank.

      Netherlands: Deventer, Heerlen, Tilburg.

      Austria: Eisenstadt, Linz.

      Poland: Gdańsk.

      Sweden: Huddinge.

      Spain: Majadahonda, Toledo.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Based on the information provided about this clinical trial, here are the key steps a patient would need to take:

      1. Screening Period (2 visits): Patients will be assessed to determine if they meet the eligibility criteria to participate in the trial. This includes having a diagnosis of heart failure and pulmonary hypertension, and undergoing tests like a right heart catheterization.
      2. Treatment Period (24 weeks, 13 visits):
        • Patients will be randomly assigned to one of 4 treatment groups in a 1:1:1:1 ratio.
        • 3 groups will receive different dose levels of the study drug AZD3427 (Dose A, B or C), given as a subcutaneous injection every 2 weeks.
        • 1 group will receive a placebo injection every 2 weeks.
        • Treatment continues from Day 1 to Day 155.
      3. Follow-up Period (1 visit): A final follow-up visit occurs after treatment ends.

      The timeline for a patient looks like:

      • Screening Period: 2 visits (duration not specified)
      • Treatment Period: Day 1 to Day 155, with injections every 2 weeks (total of 24 weeks)
      • Follow-up visit: After treatment ends (timing not specified)
      • Total patient participation: Approximately 32-37 weeks

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria in the clinical trial information, to join this study you would need to have the following diseases:

      • Heart failure (HF), NYHA function class II to IV
      • Pre-existing diagnosis of pulmonary hypertension due to left heart disease (PH-LHD) or likely/intermediate probability of PH-LHD per 2022 ESC/ERS guidelines

      The key exclusion criteria related to diseases are:

      • Diagnosis of pulmonary hypertension in WHO Groups 1, 3, 4, or 5
      • Known lung disease with FEV1 < 30% of predicted
      • Congenital long QT syndrome

      So in summary, the main diseases required are heart failure and pulmonary hypertension specifically due to left heart disease. Certain other diseases like other types of pulmonary hypertension, severe lung disease, and congenital long QT syndrome would exclude someone from participating.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join this study, you must meet the following inclusion criteria:

      Age

      • You must be at least 18 years old

      Medical Diagnosis

      • You must have a pre-existing diagnosis of heart failure (HF) with New York Heart Association (NYHA) functional class II to IV
        • The NYHA functional classification places patients in one of four categories based on how much they are limited during physical activity
      • You must have a pre-existing diagnosis of pulmonary hypertension due to left heart disease (PH-LHD) or likely/intermediate probability of PH-LHD according to 2022 European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines
      • You must be on stable heart failure standard of care medication, including diuretics

      Echocardiogram and Right Heart Catheterization Results

      • You must have a combination of echocardiogram parameters that show intermediate or high probability of pulmonary hypertension according to 2022 ESC/ERS guidelines
        • An echocardiogram is an ultrasound of the heart that evaluates heart structure and function
      • You must have the following results from a right heart catheterization (RHC) performed during screening:
        • Pulmonary artery wedge pressure (PAWP) greater than or equal to 15 mmHg
        • Mean pulmonary artery pressure (mPAP) greater than or equal to 20 mmHg
        • RHC is a procedure where a catheter is threaded through the right side of the heart to directly measure pressures in the heart and lungs

      Other

      • Your body weight must be at least 45 kg (99 lbs)
      • You must be capable and willing to provide signed informed consent

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you cannot take part in this study if you have any of the following:

      Other Types of Pulmonary Hypertension
      – WHO Group 1 (pulmonary arterial hypertension), WHO Group 3 (PH due to lung diseases), WHO Group 4 (chronic thromboembolic PH), or WHO Group 5 (PH with unclear causes)

      Certain Medical Conditions
      – Clinically significant disease or disorder
      – Decompensated heart failure (worsening of heart failure symptoms) or recent hospitalization for decompensated heart failure
      – Conditions preventing right heart catheterization procedure
      – Hypersensitivity (allergy) to subcutaneous injections or devices
      – Hypersensitivity to drugs similar to the study drug AZD3427
      – Severe lung disease with FEV1 (a measure of lung function) less than 30% of predicted
      – Congenital long QT syndrome (a heart rhythm disorder)
      – Ventricular arrhythmia requiring treatment (abnormal heart rhythms originating in the ventricles)
      – Previous or planned heart transplant or ventricular assist device
      – Planned invasive cardiovascular procedures (e.g. coronary revascularization, valve repair/replacement, etc.)

      Prior Treatments
      – Previous treatment with the study drug AZD3427


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The study involves the following drugs:

      1. AZD3427 (active substance unknown)
        • AZD3427 is an investigational drug being studied at three different dose levels (Dose A, Dose B, Dose C) in patients with heart failure and pulmonary hypertension. It is administered as a subcutaneous injection every 2 weeks for 24 weeks.
        • The goal is to assess the ability of AZD3427 to reduce pulmonary vascular resistance compared to placebo.
      2. Placebo
        • Placebo is an inactive substance used as a comparator to AZD3427 in this study. It is also administered as a subcutaneous injection every 2 weeks for 24 weeks.
        • Using a placebo helps determine if the effects seen with AZD3427 are truly due to the active drug or other factors.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Based on the information provided in the clinical trial description, the active substances participating in this trial are:

      1. AZD3427
        • AZD3427 appears to be an investigational drug being studied for the treatment of pulmonary hypertension due to left heart disease (WHO Group 2). As an investigational drug, it is likely not yet well known in medicine or the medical literature, as its safety and efficacy are still being evaluated in clinical trials.
      2. Placebo
        • Placebo is an inactive substance used as a control in clinical trials. It is well known in medicine and medical literature as a standard comparator to evaluate the effectiveness of the investigational drug.

      Study ID

      CT-EU-00029829

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago