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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
St Vincent’s University Hospital	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	30.09.2023

Trial locations

Investigated drugs:

Empagliflozin

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.

Investigated diseases:

Cardiac failure

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.

Trial ID:

2024-512062-34-00

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?