Study on the Effects of Sacubitril/Valsartan and Ramipril on Heart Function in Patients with Ischemic Heart Failure with Mid-Range Ejection Fraction

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What is this study about?

This clinical trial is focused on studying the effects of two medications, sacubitril and valsartan, compared to ramipril, in patients with a specific type of heart failure known as heart failure with moderately reduced ejection fraction (HFmrEF). This condition affects the heart’s ability to pump blood effectively, and the study aims to understand how these medications can impact heart function and structure over time.

The purpose of the study is to evaluate how sacubitril/valsartan and ramipril affect the heart’s left ventricle, which is the main pumping chamber. The study will look at changes in the size and function of the left ventricle using a special imaging technique called magnetic resonance imaging (MRI). Participants will be treated for 12 months, and the study will monitor changes in heart function and any hospitalizations related to heart failure during this period.

Participants will take the medications orally, and the study will involve regular check-ups to assess heart health and any side effects. The trial will also include a comparison with a placebo, which is a substance with no active medication, to better understand the effects of the treatments. The study aims to provide valuable insights into the management of ischemic heart failure, which is heart failure caused by reduced blood flow to the heart.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

An echocardiogram is performed to measure the left ventricular ejection fraction, which should be between 40-49%.

2 screening visit

During the screening visit, blood tests are conducted to measure the concentration of NT-proBNP, a marker related to heart function.

The concentration should be at least 125 pg/ml if in sinus rhythm, or at least 350 pg/ml if experiencing atrial fibrillation or flutter.

3 randomization

Participants are randomly assigned to receive either valsartan and sacubitril or ramipril.

Both medications are taken orally. The specific dosage and frequency are determined by the study protocol.

4 treatment period

The treatment period lasts for 12 months. During this time, participants continue taking the assigned medication.

Regular follow-up visits are scheduled to monitor health and adjust treatment if necessary.

5 magnetic resonance imaging (MRI)

An MRI is conducted to measure changes in the heart’s structure and function, specifically the left ventricular end-systolic volume.

This imaging is performed at the start and end of the 12-month treatment period.

6 final assessment

At the end of the study, a final assessment is conducted to evaluate the effects of the treatment.

This includes a review of any changes in heart function and any hospitalizations or cardiovascular events that occurred during the study.

Who Can Join the Study?

Provide written consent to participate in the study before any study-related procedures begin.
Be 18 years or older.
Have symptoms of heart failure (HF) classified as NYHA class II to IV, which means moderate to severe symptoms, due to ischemic causes, which means related to reduced blood flow to the heart.
Have a left ventricular ejection fraction (LVEF) between 40% and 49% at the screening visit. This is a measure of how well the heart pumps blood, confirmed by an echocardiogram at a later visit.
Have an elevated concentration of a substance called NT-proBNP, which is a marker of heart stress, at the screening visit. If the heart rhythm is normal, the level should be 125 pg/ml or higher.
If there is an irregular heart rhythm like atrial fibrillation or flutter, the NT-proBNP level should be 350 pg/ml or higher at the screening visit.
Show signs of a structural or functional disease of the left ventricle, which is the main pumping chamber of the heart.
Be on the best possible treatment with medications called ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) and beta-blockers, unless there is a medical reason not to use them.

Who Cannot Join the Study?

Patients with severe heart conditions other than heart failure with moderately reduced ejection fraction (HFmrEF). HFmrEF is a type of heart failure where the heart’s ability to pump blood is moderately reduced.
Individuals who have had a recent heart attack or other major heart event.
Patients with severe kidney or liver disease.
People who are allergic to the study medications, such as sacubitril, valsartan, or ramipril.
Women who are pregnant or breastfeeding.
Individuals who are unable to undergo magnetic resonance imaging (MRI). MRI is a type of scan that uses magnets and radio waves to create detailed images of the inside of the body.
Patients who are currently participating in another clinical trial.
Individuals with any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Slaskie Centrum Chorob Serca W Zabrzu	Zabrze	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Kalvzmzaj Sfiqpsi Snjlddczsqkohtw ik Jdiy Piwvb Ij	Cracow	Poland
Mnbcsvmo Smn z orrb	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Sacubitril/Valsartan is a medication used in this study to treat patients with heart failure. It works by helping the heart pump blood more effectively and reducing the strain on the heart. This medication is a combination of two drugs that work together to improve heart function and prevent further damage.

Ramipril is another medication used in the study for treating heart failure. It helps relax blood vessels, making it easier for the heart to pump blood. This can help improve symptoms of heart failure and reduce the risk of complications.

Heart Failure with Moderately Reduced Ejection Fraction (HFmrEF) – This condition is a type of heart failure where the heart’s left ventricle does not pump blood as efficiently as it should, with an ejection fraction that is moderately reduced. It often results from damage to the heart muscle, such as from a heart attack, leading to a decrease in the heart’s ability to pump blood effectively. Over time, this can cause symptoms like shortness of breath, fatigue, and fluid retention. The heart may undergo structural changes, known as remodeling, which can further impact its function. Patients with HFmrEF may experience a gradual worsening of symptoms as the heart’s pumping ability declines. The condition requires careful management to maintain heart function and quality of life.

Trial ID:

2024-518239-12-00

Protocol code:

DW.0701.005.2020P

NCT ID:

NCT05508035

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Sacubitril/Valsartan and Ramipril on Heart Function in Patients with Ischemic Heart Failure with Mid-Range Ejection Fraction

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?