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Study on Empagliflozin's Effect on Heart Function in Non-Diabetic Pre-Heart Failure Patients Using Fitbit and mHealth for Exercise Guidance

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 Empagliflozin on individuals with a condition known as Pre-Heart Failure, specifically in those who do not have diabetes. Pre-Heart Failure is a stage where the heart is at risk of developing heart failure, but it has not yet occurred. The medication being tested, Empagliflozin, is taken in the form of film-coated tablets and is commonly used to manage blood sugar levels in people with diabetes. However, this study aims to explore its potential benefits for heart health in non-diabetic individuals.

The purpose of the study is to assess how Empagliflozin affects the heart's function over a period of six months. Participants will be monitored to see if there are any changes in the size of the heart's left atrium, which is a chamber of the heart, using a method called Cardiac Magnetic Resonance (CMR). This method provides detailed images of the heart to help doctors understand its structure and function. Additionally, the study will explore the use of Fitbit devices and mobile health technology to encourage exercise among participants, as regular physical activity is known to support heart health.

Throughout the study, participants will take Empagliflozin daily and undergo regular check-ups to monitor their heart's condition. The study will last for six months, during which various heart-related measurements will be taken to evaluate any changes. This research aims to provide insights into whether Empagliflozin can be beneficial for heart health in people who are at risk of heart failure but do not have diabetes.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria such as age, cardiovascular risk factors, and non-diabetic status.
Written informed consent is required, and access to a smartphone is necessary for participation.
Step 2
Baseline assessment
Initial measurements are taken, including the left atrial volume index (LAVI) using Doppler echocardiography.
Additional baseline assessments may include cardiac magnetic resonance imaging (CMR) to measure various heart parameters.
Step 3
Medication administration
The medication Jardiance (empagliflozin) is administered orally in the form of 10 mg film-coated tablets.
The medication is taken as prescribed throughout the study duration of six months.
Step 4
Exercise and monitoring
Participants are provided with a Fitbit device to monitor physical activity.
Exercise is prescribed and monitored using mHealth technology to ensure adherence to the exercise regimen.
Step 5
Follow-up assessments
Regular follow-up assessments are conducted to monitor changes in heart function and other health parameters.
These assessments include CMR to evaluate changes in heart structure and function over the six-month period.
Step 6
Final evaluation
At the end of the six-month period, a final evaluation is conducted to assess the impact of the medication and exercise regimen.
Changes in heart parameters and overall health are analyzed to determine the study's outcomes.

Who can join the trial?

13 criteria

Must be over 40 years old and have at least one heart-related risk factor, such as:
- Hypertension: High blood pressure
- Coronary artery disease: Problems with the blood vessels of the heart
- Obesity: Being very overweight
- Previous ischaemic stroke or TIA: Past events where blood flow to the brain was reduced
- Peripheral vascular disease: Blood circulation disorder outside of the heart and brain
- Hypercholesterolaemia: High cholesterol levels
- Previous chemotherapy or radiotherapy to the chest: Past cancer treatments affecting the chest area
- Not currently taking SGLT-2i treatment: A type of medication for diabetes
- LAVI ≥29mL/m² measured by Doppler echocardiography: A specific heart measurement
- Willing and able to use a Fitbit and follow an exercise plan
- Must be able and willing to provide written consent to participate
- Must have access to a smartphone
- Must not have diabetes

Who cannot join the trial?

9 criteria

Patients with diabetes cannot participate.
Patients who have already been diagnosed with heart failure are not eligible.
Individuals who are not within the specified age range for the study cannot join. The age range is typically defined by the study organizers.
Participants who are unable to undergo a specific type of heart imaging test called CMR (Cardiac Magnetic Resonance) are excluded. This test uses magnets and radio waves to create detailed pictures of the heart.
Patients with other serious health conditions that might interfere with the study results are not allowed to participate.
Individuals who are pregnant or breastfeeding are excluded from the study.
Participants who are currently taking certain medications that could affect the study outcomes are not eligible.
People who have participated in another clinical trial recently may not be allowed to join this study.
Individuals who are unable to give informed consent, which means they cannot fully understand and agree to the study's requirements, are excluded.

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Verified sites

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St Vincent's University Hospital
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Dublin, Ireland

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Investigated drugs

Empagliflozin
is a medication used in this study to see how it affects the heart, specifically the left atrial volume, in patients who do not have diabetes but are at risk of heart failure. The study aims to understand if this medication can help improve heart function over a period of six months.
Fitbit and mHealth
are technologies used in this study to help prescribe and monitor exercise routines for participants. Fitbit is a wearable device that tracks physical activity, while mHealth refers to mobile health technologies that can support health and wellness through apps and other digital tools. These technologies are used to encourage and track exercise as part of the study.

Empagliflozin

What is already known about the treatment

Empagliflozin – Empagliflozin is administered orally in tablet form. It is currently being studied for its effects on pre-heart failure in non-diabetic patients, with a focus on improving heart function. The main therapeutic indication is to address diastolic dysfunction, which is a condition where the heart has difficulty relaxing and filling with blood. At the molecular level, empagliflozin 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 function. 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-related benefits.

Investigated diseases

Pre-Heart Failure (Non-diabetic) – This condition refers to an early stage of heart failure where the heart is not yet failing but is at risk of doing so. It is characterized by changes in the heart's structure and function, such as diastolic dysfunction, where the heart has difficulty relaxing and filling with blood. Patients may experience symptoms like shortness of breath or fatigue during physical activity. Over time, these changes can progress, potentially leading to more severe heart failure if not managed. The focus is often on monitoring heart function and making lifestyle adjustments to prevent further progression. This condition is specifically noted in individuals who do not have diabetes, which can influence heart health differently.