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Study on the Effects of Dapagliflozin for Patients with Refractory Heart Failure

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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 medication called dapagliflozin, which is available as Forxiga 10 mg film-coated tablets. The study is specifically looking at patients with refractory heart failure, a condition where the heart is unable to pump blood effectively, and the symptoms do not improve with standard treatments. The purpose of the study is to explore how dapagliflozin affects the removal of sodium from the body through urine and a process called peritoneal dialysis, which is a treatment for patients with kidney problems.

Participants in the study will take dapagliflozin to see if it helps increase the amount of sodium removed from their bodies. The study will monitor how the medication affects the body's ability to get rid of sodium through urine and peritoneal dialysis over a period of time. This is important because managing sodium levels can help improve symptoms in patients with heart failure.

The study will involve a group of patients who will be observed to see how their bodies respond to the treatment. The goal is to determine if dapagliflozin can help improve the management of sodium levels in patients with heart failure who are also undergoing peritoneal dialysis. This research could provide valuable insights into better treatment options for individuals with this challenging condition.

The research process

The trial runs in 4 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 patient must provide signed informed consent. This includes agreeing to the requirements and restrictions outlined in the consent form.
The patient must be at least 18 years old and have a confirmed diagnosis of heart failure, classified as NYHA functional class I-III.
The patient should be undergoing peritoneal dialysis and have chronic kidney disease with an eGFR of less than 60 ml/min/1.73 m².
The patient must have been on stable doses of furosemide or an alternative loop diuretic for at least 14 days and stable heart failure therapy for at least one month prior to consent.
Step 2
Medication administration
The patient will receive Forxiga 10 mg film-coated tablets, which contain the active substance dapagliflozin.
The medication is administered orally, meaning it is taken by mouth.
The dosage is one tablet per day, and the duration of administration will be determined by the study protocol.
Step 3
Monitoring and evaluation
The study aims to explore the effect of dapagliflozin on diuresis, natriuresis, and the peritoneal elimination of sodium in patients with refractory heart failure.
The primary endpoint involves measuring the sum of natriuresis over 24 hours and daily peritoneal dialytic sodium removal, with an expected increase in values after treatment.
Regular monitoring will be conducted to assess the patient's response to the medication and any changes in sodium elimination.
Step 4
Completion of the study
The estimated end date for the study is May 30, 2024.
Upon completion, the patient's participation in the study will conclude, and any further instructions or follow-up will be provided as per the study protocol.

Who can join the trial?

10 criteria

The person must be able to understand and sign a form that explains the study and agrees to follow the study's rules.
The person must sign the consent form before any study-related activities or tests begin.
The person must be **18 years or older** at the time of signing the consent form.
The person must have a confirmed diagnosis of **Heart Failure (HF)**, which is a condition where the heart doesn't pump blood as well as it should. This should be according to specific guidelines and can be of types called **HFrEF** or **HFpEF**.
The person must be receiving treatment using a method called **Peritoneal Dialysis**, which is a way to remove waste products from the blood when the kidneys are not working well.
The person must have **Chronic Kidney Disease (CKD)**, which means the kidneys are not working properly, with a specific measure called **eGFR** being less than 60.
The person must have been on **Peritoneal Dialysis** for more than 30 days.
The person must be taking a stable dose of a medication called **furosemide** or another similar medication for at least 14 days. These medications help the body get rid of extra fluid.
The person must be on stable treatment for **Heart Failure** for at least 1 month before signing the consent form.
The person must not have been hospitalized for **Heart Failure** for at least 1 month before signing the consent form.

Who cannot join the trial?

4 criteria

Patients who do not have refractory heart failure. This means their heart failure does not continue to worsen despite treatment.
Patients who are not undergoing peritoneal dialysis. This is a treatment for kidney failure that uses the lining of your abdomen to filter waste from your blood.
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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Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA
Valencia, Spain

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Investigated drugs

Dapagliflozin is a medication used in this trial to study its effects on diuresis, natriuresis, and the elimination of sodium through peritoneal dialysis in patients with refractory heart failure. It belongs to a class of drugs known as SGLT2 inhibitors, which help the kidneys remove glucose from the bloodstream. In this study, researchers are exploring how this medication can aid in the removal of excess sodium and fluid in patients with chronic kidney disease and heart failure.

Dapagliflozin

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied for its effects on diuresis and sodium elimination in patients with refractory heart failure, particularly those undergoing peritoneal dialysis. The main therapeutic indication for dapagliflozin is to manage heart failure and improve kidney function. At the molecular level, it works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases sodium excretion. Dapagliflozin is classified as an SGLT2 inhibitor, a type of medication primarily used to treat type 2 diabetes and heart failure.

Investigated diseases

Refractory Heart Failure – Refractory heart failure is a condition where the heart is unable to pump blood effectively, despite treatment. This leads to persistent symptoms such as shortness of breath, fatigue, and fluid retention. The heart's inability to meet the body's demands results in a chronic state of inadequate blood flow. Over time, this can cause the heart muscle to weaken further, exacerbating symptoms. Patients may experience frequent hospitalizations due to worsening symptoms. The condition requires ongoing management to alleviate symptoms and improve quality of life.