Study on Dapagliflozin for Heart Failure Patients After a Heart Attack

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dapagliflozin on patients who have experienced a heart attack, also known as an acute myocardial infarction. The study aims to see if dapagliflozin can help improve heart function and structure after a heart attack. Dapagliflozin is a type of medication that is usually used to treat diabetes, but in this study, it is being tested for its potential benefits on the heart. Participants in the study will either receive dapagliflozin or a placebo, which is a substance with no active medication, in addition to their standard heart treatment.

The purpose of the study is to assess how well dapagliflozin works in improving heart function and reducing changes in the heart’s structure over a period of six months. This will be done using a test called a transthoracic echocardiography (TTE), which is a type of ultrasound that looks at the heart. The study will monitor changes in the heart’s pumping ability and size, as well as other heart-related measurements. Participants will be followed for six months to see how their heart responds to the treatment.

Throughout the study, researchers will also keep track of any side effects or health changes that occur. This includes monitoring for symptoms like dehydration, low blood sugar, infections, and changes in kidney or liver function. The study will help determine if dapagliflozin can be a beneficial addition to standard heart attack treatments, potentially improving recovery and outcomes for patients with heart failure following a heart attack.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, specific heart conditions, and blood pressure levels.

Written consent is required to participate in the study, which lasts for a 6-month follow-up period.

2 randomization and initial assessment

Participants are randomly assigned to receive either dapagliflozin or a placebo. Dapagliflozin is a medication taken orally.

Initial assessments include measuring heart function and structure using a test called transthoracic echocardiography (TTE).

3 medication administration

Participants take dapagliflozin or placebo daily. The dosage for dapagliflozin is 10 mg.

The medication is taken in addition to standard recommended therapy for heart conditions.

4 ongoing monitoring

Throughout the study, participants are monitored for changes in heart function and structure using TTE.

Participants are also monitored for any adverse events, particularly those related to dapagliflozin, such as symptoms of volume depletion or changes in kidney function.

5 final assessment

At the end of the 6-month period, a final assessment is conducted to evaluate changes in heart function and structure.

The study aims to assess the effectiveness of dapagliflozin in improving heart function and reducing heart remodeling after a heart attack.

Who Can Join the Study?

Must be at least 18 years old.
Must have experienced a type of heart attack called STEMI or a very high-risk NSTEMI. These are specific types of heart attacks that can be identified by certain changes in heart tests or symptoms like ongoing chest pain or heart failure.
Must have LV dysfunction, which means the heart’s left side is not pumping well, with a measurement called LVEF of 45% or less. This is checked after a heart procedure like PCI or angiography.
Must have a kidney function test result called eGFR of at least 25 mL/Min per 1.73m². This measures how well the kidneys are working.
Must have a systolic blood pressure (the top number) greater than 100 mmHg and/or a diastolic blood pressure (the bottom number) greater than 70 mmHg before the first dose of the study medication.
Must be able to provide written consent, which means agreeing to participate in the study and understanding what it involves.
Must be willing to participate in the study for a 6-month follow-up period.
Must be part of a national health care system. People who are not part of such a system cannot participate.

Who Cannot Join the Study?

Patients with cardiac failure cannot participate. This means the heart is not pumping blood as well as it should.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not part of the specified clinical trial group cannot participate. This refers to specific categories of patients the study is focusing on.
Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopital Cardiologique	Lille	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble	Grenoble	France
Les Hopitaux De Chartres	Le Coudray	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Clinique Du Pont De Chaume	Montauban	France
Centre Hospitalier Saint Joseph Saint Luc	Lyon	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Pau	Pau	France
Ivsvzpug Rjzavsev Dj Cpksey Df Msfxtaobsfk	Montpellier	France
Crs dojsaekczfudyc	Epagny Metz Tessy	France
Circxz Haekqvpwrbr Uhqwxmtbugsev Dk Dcpcd	Dijon	France
Bfzccjqz Uizpawhiyo Hrhnbbma Cotlko	Besançon	France
Cyiviw Hhoaxudoeqg Rkfamouj Unkwzkypzdmam Dn Ttbah	Tours	France
Ckspzx Hmabklsqauy Rnspobdh Ducpzfgmdevjal	Angers	France
Cac Cbzvi Ryvatrvgxjd	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.12.2022

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication used in this trial to help improve heart function after a heart attack. It is being tested to see if it can help the heart pump better and reduce changes in the heart’s structure when used alongside standard heart treatments.

Cardiac Failure – Cardiac failure, also known as heart failure, is a condition where the heart is unable to pump blood effectively to meet the body’s needs. This can result from the heart being too weak or too stiff to fill and pump properly. Over time, the heart’s reduced ability to function can lead to symptoms such as fatigue, shortness of breath, and fluid retention. The condition can progress as the heart’s pumping capacity continues to decline, potentially affecting other organs due to inadequate blood supply. It often involves changes in the heart’s structure and function, such as enlargement of the heart chambers and thickening of the heart walls. Monitoring and managing the condition is crucial to prevent further deterioration of heart function.

Trial ID:

2024-511882-13-01

Protocol code:

APHP211054

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dapagliflozin for Heart Failure Patients After a Heart Attack

What is this study about?

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