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Study on How Sacubitril/Valsartan and Enalapril Affect Lung Pressure in Patients with Heart Failure with Reduced Ejection Fraction

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Heart Failure with reduced ejection fraction, a condition where the heart muscle doesn’t pump blood as well as it should. The study will compare two treatments: Entresto, which contains the active substances valsartan and sacubitril, and Enalapril, a medication commonly used to treat heart failure. The purpose of the study is to assess how these treatments affect the pressure in the lungs and the resistance in the blood vessels of the lungs in patients who have developed high blood pressure in the lungs due to heart failure.

Participants in the study will be randomly assigned to receive either Entresto, Enalapril, or a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for a period of up to 13 weeks, during which participants will take the medication by mouth in the form of tablets. Throughout the study, various tests will be conducted to monitor changes in lung pressure, heart function, and overall health. These tests may include heart imaging, exercise tests, and questionnaires about quality of life.

The study aims to provide valuable information on how these treatments can help manage heart failure and improve the quality of life for patients. By comparing the effects of Entresto and Enalapril, researchers hope to better understand which treatment may be more effective in reducing lung pressure and improving heart function in patients with heart failure. The results of this study could lead to improved treatment options for individuals living with this condition.

1 joining the study

Upon joining the study, participants are required to sign an informed consent form. This indicates understanding and acceptance of the study’s methods and objectives.

2 initial assessment

Participants undergo an initial assessment to confirm eligibility. This includes a right heart catheterization to check for pulmonary hypertension, which is high blood pressure in the lungs’ arteries, due to heart failure with reduced ejection fraction.

3 medication administration

Participants are randomly assigned to receive either Entresto (containing sacubitril and valsartan) or Enalapril. Both medications are taken orally in tablet form.

The dosage for Entresto is 24 mg/26 mg, while Enalapril is administered at 2.5 mg. The frequency and duration of administration are determined by the study protocol.

4 ongoing monitoring

Participants are monitored for changes in pulmonary artery pressure and pulmonary vascular resistance. These are key indicators of the study’s primary objectives.

Secondary assessments include changes in pulmonary wedge pressure, diastolic pressure gradient, and performance in a 6-minute walk test.

5 additional evaluations

Participants undergo additional evaluations such as spiroergometric tests, echocardiographic assessments, and quality of life questionnaires. These help measure the impact of the treatment on daily life and physical capabilities.

6 completion of the study

The study is estimated to conclude by October 31, 2025. Participants will have their final assessments to evaluate the overall effects of the treatment.

Who Can Join the Study?

  • Must be at least 18 years old and able to complete and sign the informed consent form.
  • Have heart failure and be classified as NYHA II-IV. This means experiencing symptoms ranging from mild to severe.
  • Undergo a test called right heart catheterization (RHC) that shows post-capillary pulmonary hypertension. This is a condition where the blood pressure in the lungs is higher than normal due to heart failure.
  • Have stable heart function, meaning no changes in the use of water pills (diuretics) for at least 4 weeks before joining the study.
  • Be receiving the best possible treatment for heart failure, which may include medications like ACE inhibitors, ARBs, beta blockers, MRAs, and SGLT2 inhibitors, unless these treatments are not suitable or tolerated.
  • Understand and agree to the study’s goals and methods, and sign the informed consent form.

Who Cannot Join the Study?

  • Patients who do not have heart failure with reduced ejection fraction. This means the heart is not pumping as well as it should.
  • Patients who are not experiencing pulmonary hypertension. This is high blood pressure in the blood vessels that supply the lungs.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

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 Status
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Sdqkmcj Syhyvavixuqanka W Zeeyac Skc z oiyy Zabrze Poland
Wxwpcwxqgcgmywilrbtj Sykbmlu Sbfgnfmabsg Phtyoecla Zyoqzv Oajeqb Zbeprnjbme w Nnraa Sqlk Nowa Sol Poland
Mvdrumq Sxrgshg Zynogzgpq w Oqzhpefut Olsztyn Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.12.2022

Trial locations

Investigated drugs:

Sacubitril/Valsartan is a medication used in this trial to treat patients with heart failure with reduced ejection fraction. It works by relaxing blood vessels, which helps to lower blood pressure and reduce the strain on the heart. This medication is being studied to see if it can reduce pulmonary artery pressure and improve blood flow in the lungs.

Enalapril is another medication used in this trial for comparison. It is an ACE inhibitor that helps to relax blood vessels and lower blood pressure, similar to sacubitril/valsartan. The trial aims to compare the effects of enalapril with sacubitril/valsartan on heart and lung function in patients with heart failure.

Investigated diseases:

Heart Failure with Reduced Ejection Fraction – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a decrease in the amount of blood ejected from the heart with each beat. Over time, this can cause symptoms such as shortness of breath, fatigue, and fluid retention. The heart’s reduced ability to pump blood can lead to increased pressure in the blood vessels of the lungs, known as pulmonary hypertension. As the condition progresses, it can affect the heart’s ability to supply enough blood to meet the body’s needs, impacting daily activities and overall quality of life.

Trial ID:
2024-517975-19-00
Protocol code:
2019/ABM/01/00078
Trial Phase:
Therapeutic confirmatory (Phase III)

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