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Study on the Effects of AZD3427 on Kidney Function in Heart Failure Patients with Kidney Issues

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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 the effects of a new treatment called AZD3427 on patients with two specific health conditions: Heart Failure with Reduced Ejection Fraction (HFrEF) and Renal Impairment. Heart failure with reduced ejection fraction is a condition where the heart muscle does not pump blood as well as it should, and renal impairment refers to reduced kidney function. The purpose of the study is to evaluate how AZD3427 affects blood flow in the kidneys of these patients.

Participants in the study will receive either the treatment AZD3427 or a placebo, which is a substance with no active medication. The study will also use a special imaging technique called Positron Emission Tomography (PET) to observe changes in kidney blood flow. In addition to AZD3427, other substances used in the study include Dopamine Hydrochloride, 15O-WATER, and Sodium Chloride, which are used to help with the imaging process or as part of the treatment protocol.

The study will be conducted over a period of time, during which participants will undergo various assessments to monitor their health and the effects of the treatment. These assessments will include checking vital signs, laboratory tests, and heart monitoring through an ECG (electrocardiogram). The study aims to provide valuable information on the safety and effectiveness of AZD3427 in improving kidney function in patients with heart failure and kidney impairment.

The research process

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

Step 1
Joining the study
Upon joining the study, the participant will be required to provide informed consent, confirming understanding and agreement to comply with the study requirements.
The participant must meet specific criteria, including age, medical history, and current health status, to be eligible for the trial.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the participant's health status. This includes checking heart function and kidney performance.
The participant's current medications will be reviewed to ensure stability and compatibility with the trial requirements.
Step 3
Medication administration
The participant will receive the study medication, AZD3427, or a placebo. The medication is administered as a solution for injection.
The administration will occur under controlled conditions, with medical staff present to monitor the participant's response.
Step 4
Monitoring and follow-up
The participant will undergo regular monitoring to assess the effects of the medication. This includes checking vital signs and conducting laboratory tests.
Positron Emission Tomography (PET) scans will be used to measure changes in kidney function, specifically the volume of the renal cortex with increased perfusion.
Step 5
Final evaluation
At the end of the trial period, a final evaluation will be conducted to assess the overall impact of the medication on the participant's health.
The participant's safety and any side effects experienced during the trial will be reviewed and documented.

Who can join the trial?

11 criteria

Participant must be older than 20 years at the time of signing the informed consent.
Male participants who have been sterilized must use a condom from the time of study intervention until 3 months after the dosing. They must have a medical assessment confirming the success of the sterilization surgery.
Participant must be able and willing to sign the informed consent, which includes agreeing to follow the study's requirements and restrictions.
Participant must have suitable veins for inserting a small tube (cannulation).
Participants must have been diagnosed with heart failure (HF) classified as NYHA I to III for at least 12 months. NYHA is a way to classify the severity of heart failure symptoms.
Participants must be on stable heart failure medication for at least 4 weeks before screening, with no significant changes in dose or new medications added during that time. If taking diuretics (medications that help remove excess fluid), they must also be stable for at least 4 weeks before screening. No changes in treatment affecting kidney function should occur between screening and Visit 3.
Participants must have a left ventricular ejection fraction of 40% or less based on an echocardiogram done within the last 6 months. Ejection fraction is a measure of how well the heart pumps blood.
Participants must have an estimated glomerular filtration rate (eGFR) between 30 to 90 mL/min/1.73 m², assessed by a specific equation, at screening. eGFR is a measure of kidney function.
Participants must have a minimum body mass index (BMI) of 18.0 kg/m² and a minimum body weight of 50 kg at screening. BMI is a measure of body fat based on height and weight.
Female participants must not be pregnant or breastfeeding and must be unable to have children, confirmed by one of the following: (a) Being postmenopausal, which means not having a period for 12 months after stopping all hormone treatments, with certain hormone levels in the postmenopausal range. (b) Having had irreversible surgical sterilization, such as removal of the uterus, both ovaries, or both fallopian tubes. Tubal ligation is not considered irreversible.
All male participants should avoid fathering a child or donating sperm until 3 months after dosing. Non-sterilized male participants should avoid fathering a child by either abstaining from sexual intercourse or using a condom during all sexual intercourse with a female partner who can have children, from dosing until 3 months after dosing. The female partner must either be unable to have children or use a highly effective form of birth control until 3 months after dosing. The chosen method of birth control should be stable for at least 3 months before dosing. Highly effective birth control methods include: (a) Combined hormonal contraception (containing estrogen and progestogen) that prevents ovulation, taken orally, intravaginally, or transdermally. (b) Progestogen-only hormonal contraception that prevents ovulation, taken orally, by injection, or implant. (c) Intrauterine device (IUD). (d) Intrauterine hormone-releasing system. (e) Bilateral tubal occlusion of the female partner.

Who cannot join the trial?

4 criteria

Patients with severe **heart failure**. This means the heart is not pumping blood as well as it should.
Patients with serious **kidney problems**. This refers to the kidneys not working properly.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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CTC Clinical Trial Consultants AB
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Uppsala, Sweden

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Investigated drugs

AZD3427 is a medication being studied for its potential effects on kidney function in patients with heart failure and reduced kidney function. The trial aims to see how this medication might improve blood flow in the kidneys, which is important for maintaining healthy kidney function. The study uses a special imaging technique called Positron Emission Tomography (PET) to observe these effects.

What is already known about the treatment

AZD3427 – This medication is administered orally and is currently being studied in clinical trials. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indications for AZD3427 include heart failure with reduced ejection fraction and renal impairment. At the molecular level, AZD3427 works by improving blood flow to the kidneys, potentially enhancing kidney function in affected patients. It is classified pharmacologically as a renal perfusion agent.

Investigated diseases

Heart Failure with Reduced Ejection Fraction
This condition occurs when the heart muscle is unable to pump blood effectively, leading to a decrease in the amount of blood ejected from the heart with each beat. Over time, this can result in symptoms such as shortness of breath, fatigue, and fluid retention. The heart's reduced ability to pump blood can cause the body to receive less oxygen and nutrients, affecting overall function. As the condition progresses, individuals may experience worsening symptoms and decreased exercise tolerance. The heart may also undergo structural changes, such as enlargement or thickening of the heart muscle. Management focuses on improving heart function and alleviating symptoms.
Renal Impairment
This condition involves a decline in kidney function, where the kidneys are less able to filter waste and excess fluids from the blood. It can develop gradually over time or occur suddenly, depending on the underlying cause. Symptoms may include swelling, fatigue, and changes in urination patterns. As kidney function decreases, waste products can accumulate in the body, leading to further health complications. The progression of renal impairment can vary, with some individuals experiencing stable kidney function and others facing a gradual decline. Monitoring and lifestyle adjustments are often necessary to manage the condition.