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Study on Dapagliflozin for Patients with Chronic Right Heart Failure

Verified siteRegistered drugNo placebo

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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 in patients with chronic right heart failure. Chronic right heart failure is a condition where the right side of the heart has difficulty pumping blood effectively, which can lead to symptoms like swelling and shortness of breath. The study aims to determine if dapagliflozin, when added to the usual care, is more effective in improving the condition compared to the usual care plus a placebo.

Participants in the study will receive either dapagliflozin or a placebo, both taken as oral tablets. The treatment period will last for about three months. Throughout the study, changes in certain health markers will be monitored, such as the levels of a specific protein in the blood that indicates heart stress, known as NT-proBNP. Additionally, the study will assess changes in the participants' quality of life, heart function, and exercise capacity.

The goal of the study is to see if dapagliflozin can help reduce the symptoms and improve the overall health of people with chronic right heart failure. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for this condition in the future.

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 patient will provide written informed consent, confirming their willingness and ability to participate.
Eligibility criteria include being between 18 and 89 years old and having chronic right heart failure, as defined by specific medical assessments.
Step 2
Initial assessment
The patient will undergo initial assessments to confirm the presence of right heart failure. This includes tests like echocardiography to measure heart function and blood tests to check levels of NT-proBNP, a marker of heart failure.
Step 3
Medication administration
The patient will receive either dapagliflozin or a placebo. Dapagliflozin is taken orally, and the specific dosage and frequency will be determined by the study protocol.
The medication is administered alongside the standard care for right heart failure.
Step 4
Ongoing monitoring
Throughout the study, the patient's health and response to the medication will be monitored regularly. This includes checking NT-proBNP levels, heart function through cardiac MRI, and exercise capacity via a 6-minute walking test.
Quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire.
Step 5
End of treatment evaluation
At the end of the treatment period, the patient will undergo final assessments to evaluate changes in NT-proBNP levels, heart function, exercise capacity, and quality of life.
The study aims to determine if dapagliflozin is more effective than a placebo in improving these outcomes.

Who can join the trial?

9 criteria

The patient must be willing and able to participate and provide written consent.
The patient must be between 18 and 89 years old.
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The patient must have **chronic right heart failure**. This means the right side of the heart is not working well. Specific signs include:
- **Reduced right ventricular systolic function** or **RV strain**. This can be shown by:
  - **Tricuspid annular plane systolic excursion (TAPSE)** less than 16 mm. TAPSE is a measure of how well the right side of the heart is pumping.
  - **RV fractional area change (FAC)** less than 35%. FAC is another measure of heart pumping ability.
  - **Systolic pulmonary artery pressure (PAP sys)** of 35 mmHg or more, along with a large inferior vena cava (a big vein) that doesn't collapse much when you breathe in.
  - **N-terminal pro-BNP (NT-proBNP)** greater than 125 pg/ml. This is a blood test that shows heart stress.
  - Signs of right heart congestion, like swelling (edema), a large inferior vena cava, or fluid around the lungs, or needing medicine to prevent these signs.
  - check
    For women who can have children (until one year after menopause):
    
    A negative pregnancy test is required.
    Use of highly effective birth control methods during treatment and for 5 days after stopping the study drug.

Who cannot join the trial?

3 criteria

Patients who do not have chronic right heart failure cannot participate. This means the study is only for those with a long-term condition affecting the right side of the heart.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.

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Verified
Universitaetsmedizin Goettingen
Goettingen, Germany

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Investigated drugs

Dapagliflozin is a medication used in this trial to help treat patients with chronic right heart failure. It is being tested to see if it can improve heart function and reduce symptoms when added to the usual treatments that patients are already receiving. The goal is to determine if dapagliflozin can provide better outcomes for patients compared to the standard treatments alone.

Dapagliflozin

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating chronic right heart failure. The main therapeutic indication for dapagliflozin is to improve heart function in patients with this condition. At the molecular level, dapagliflozin works by inhibiting a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2), which helps reduce blood sugar levels and may have beneficial effects on heart health. It is classified as an SGLT2 inhibitor, a type of medication primarily used to manage blood sugar levels in diabetes but now being explored for heart failure treatment.

Investigated diseases

Chronic Right Heart Failure – This condition occurs when the right side of the heart is unable to pump blood effectively, leading to a buildup of blood in the veins. Over time, this can cause swelling in the legs and abdomen due to fluid retention. The heart's reduced ability to pump blood can also lead to fatigue and shortness of breath. As the condition progresses, the heart may become enlarged, and the symptoms can worsen. The disease often develops gradually and can be influenced by other heart or lung conditions. It requires ongoing management to address the symptoms and prevent further complications.