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Study on the Effects of Valsartan and Sacubitril for Patients with Transthyretin Cardiac Amyloidosis and 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 medication called Entresto, which contains the active substances valsartan and sacubitril, on two heart conditions: transthyretin cardiac amyloidosis and heart failure with reduced ejection fraction. Transthyretin cardiac amyloidosis is a condition where abnormal proteins build up in the heart, affecting its function. Heart failure with reduced ejection fraction is a type of heart failure where the heart does not pump blood as well as it should.

The purpose of this study is to determine how treatment with Entresto affects the heart’s ability to pump blood in patients with these conditions. Participants in the study will receive either Entresto or a placebo, and their heart function will be monitored over a period of 12 months. The main focus will be on changes in the heart’s pumping ability, measured by a test called an echocardiogram, which uses sound waves to create images of the heart.

Throughout the study, participants will undergo regular check-ups and echocardiograms to assess any changes in their heart function. The goal is to see if there is an improvement in the heart’s pumping ability after 12 months of treatment with Entresto compared to those who do not receive the medication. This research aims to provide valuable insights into the potential benefits of Entresto for patients with these specific heart conditions.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of transthyretin cardiac amyloidosis and heart failure with reduced ejection fraction. The assessment will ensure that the left ventricular ejection fraction is 40% or less, as per the study requirements.

2 medication administration

Participants will begin taking Entresto, which contains the active substances valsartan and sacubitril. The medication is provided in the form of film-coated tablets, with a dosage of 24 mg/26 mg. The tablets are to be taken orally, as prescribed by the study team.

3 regular follow-up visits

Throughout the 12-month treatment period, regular follow-up visits will be scheduled. These visits are essential for monitoring health status and assessing the impact of the medication on heart function. Adjustments to the treatment plan may be made based on these assessments.

4 echocardiogram assessments

Echocardiograms will be performed at the start of the study and after 12 months of treatment. These tests will measure the left ventricular ejection fraction to evaluate any changes in heart function. An improvement is defined as an increase of 5% or more compared to the baseline measurement.

5 completion of treatment

At the end of the 12-month period, a final assessment will be conducted to determine the overall impact of the treatment. This includes a review of all collected data and a final echocardiogram to compare with the initial results.

Who Can Join the Study?

  • Patients must be 18 years of age or older, and can be of any gender.
  • Patients must have been diagnosed with transthyretin amyloid cardiomyopathy. This can be either the hereditary form (known as ATTRv) or the wild-type form (known as ATTRwt). The diagnosis can be confirmed by a tissue test showing TTR amyloid deposits or through non-invasive methods as per guidelines. For ATTRv, a genetic test showing the specific TTR mutation is needed.
  • Patients should have been initially evaluated or be under follow-up in specialized units for Cardiomyopathy, Heart Failure, or Amyloidosis at the centers participating in the study.
  • Patients must have heart failure with reduced ejection fraction. This means the heart’s left ventricle pumps out less than or equal to 40% of the blood it contains with each beat. They should be in functional class I, II, or III according to the New York Heart Association (NYHA), which describes the severity of heart failure symptoms.

Who Cannot Join the Study?

  • Patients with any other serious heart conditions that are not related to transthyretin cardiac amyloidosis cannot participate.
  • Patients who have had a heart attack in the last 3 months are not eligible.
  • Patients with severe kidney disease are excluded.
  • Patients with severe liver disease cannot take part in the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with a history of allergic reactions to the study medication, Sacubitril/Valsartan, cannot participate.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients who have had a stroke in the last 6 months cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Clinic De Barcelona Barcelona Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Ciudad Real Ciudad Real Spain
Hgfydlwq Uxaapznqaifvg Drjbmovf Donostia / San Sebastian Spain
Hbztmrfs Upiexzobahpcs do A Cpffzp A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
16.09.2024

Trial locations

Investigated drugs:

Sacubitril/Valsartan is a medication used in this clinical trial to help improve heart function in patients with a specific type of heart disease called transthyretin amyloid cardiomyopathy, which is a condition where abnormal proteins build up in the heart. This medication is also used for patients who have heart failure with reduced ejection fraction, meaning their heart is not pumping blood as well as it should. Sacubitril/Valsartan works by relaxing blood vessels and reducing the strain on the heart, which can help improve the heart’s ability to pump blood and may lead to better heart function over time.

Transthyretin cardiac amyloidosis – Transthyretin cardiac amyloidosis is a condition where abnormal protein deposits, known as amyloid, accumulate in the heart tissue. This buildup can lead to the thickening and stiffening of the heart walls, affecting its ability to pump blood effectively. Over time, the heart’s function may decline, leading to symptoms such as fatigue, shortness of breath, and swelling in the legs. The disease progresses as more amyloid deposits form, further impairing heart function. It is a type of amyloidosis specifically involving the transthyretin protein, which is produced in the liver. The condition is considered rare and can be hereditary or acquired.

Trial ID:
2024-515661-34-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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