Study on the Safety of Starting Vericiguat at 5 mg in Patients with Chronic Heart Failure with Reduced Ejection Fraction

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What is this study about?

This clinical trial is focused on studying chronic heart failure with reduced ejection fraction, a condition where the heart is unable to pump blood effectively, leading to symptoms like fatigue and shortness of breath. The study will use a medication called vericiguat, also known by its code name BAY 1021189. Vericiguat is taken as a film-coated tablet and is being tested to see how well patients tolerate a starting dose of 5 milligrams.

The purpose of the study is to evaluate the tolerability of this starting dose in participants with chronic heart failure. Participants will begin with a 5 mg dose of vericiguat and continue for a period of two weeks. During this time, researchers will monitor the participants to ensure they can complete the two-week course without stopping the medication due to side effects or experiencing moderate to severe low blood pressure, known as hypotension.

The study will also observe any adverse effects, which are unwanted symptoms or reactions, that may occur between the start and end of the two-week period. The goal is to ensure that participants can continuously take the medication or resume it if there is any temporary interruption. This trial aims to provide valuable information on the safety and tolerability of vericiguat for individuals with chronic heart failure with reduced ejection fraction.

1 joining the study

Upon joining the study, the participant is confirmed to have chronic heart failure with reduced ejection fraction. This condition means the heart is not pumping blood as well as it should.

Eligibility is determined by specific criteria, including a left ventricular ejection fraction (LVEF) of less than 45% and stable blood pressure readings.

2 initial assessment

An initial assessment is conducted to ensure no recent changes in heart failure medication dosages and no planned medical procedures that could interfere with the study.

3 medication administration

The participant begins taking the study medication, vericiguat, which is provided as a film-coated tablet known as BAY 1021189.

The starting dose is 5 mg, taken orally once daily for a duration of two weeks.

4 monitoring period

During the two-week period, the participant’s ability to tolerate the medication is closely monitored.

The primary goal is to complete the two-week course without stopping the medication or experiencing significant drops in blood pressure.

5 evaluation of side effects

Any side effects or adverse events (AE) are recorded between the first and second visits.

The absence of side effects related to the medication is a key focus during this period.

6 completion of initial phase

The initial phase concludes with an evaluation of the participant’s experience with the medication.

Successful completion is defined by the continuous intake of the medication without significant issues.

Who Can Join the Study?

  • Have a history of chronic heart failure with a reduced ejection fraction (less than 45%). This means the heart is not pumping as well as it should.
  • Have a systolic blood pressure (the top number in a blood pressure reading) of at least 100 mmHg at the start of the study.
  • No changes in the doses of heart failure medications for a certain period before the study. This includes medications like beta blockers, ACE inhibitors, and others.
  • No planned medical procedures two weeks before or during the study.
  • Participants can be with or without a recent worsening heart failure event. This means they may have had a recent heart failure episode or not.
  • Participants must be adults, as the study includes age groups 3 and 4, which typically refer to adults.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients who do not have chronic heart failure with reduced ejection fraction. This means the heart is not pumping as well as it should.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they 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 Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Centro Cardiologico Monzino S.p.A. Milan Italy
Danderyds Sjukhus AB Danderyd Sweden
Hospital Del Mar Barcelona Spain
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Vita Longa Sp. z o.o. Katowice Poland
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j. Piotrkow Trybunalski Poland
Kalthus Heart & Horse AB Lund Sweden
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Coromed-Smo Kft. Pecs Hungary
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Centrum Medyczne Zdrowa Cracow Poland
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Niepubliczny Zaklad Opieki Zdrowotnej Twoja Przychodnia Sp. z o.o. Lublin Poland
American Heart Of Poland S.A. Kedzierzyn-Kozle Poland
Universita Degli Studi Di Brescia Brescia Italy
Axwldqg Orsuyfmmmen Uauldlnqekffb Czvzekqbshdl Djazf Sgzhzc E Dohnt Szulzik Ds Tursmu Turin Italy
Acjeoti Ovagwfpcgme Pcmn Gzhcwlpq Xcgef Bergamo Italy
Uraquylmmt Dtwvl Sycye Dd Rijb Lv Sfrszcoa Rome Italy
Fbotbdsqg Pmqc Lk Iqkrjxhgjowbj Bgbflnmbj Dja Hkrbonus Ugsmjvetlmord Lt Pel Madrid Spain

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

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
21.05.2024
Italy Italy
Not recruiting
21.05.2024
Poland Poland
Not recruiting
21.05.2024
Spain Spain
Not recruiting
21.05.2024
Sweden Sweden
Not recruiting
21.05.2024

Trial locations

Investigated drugs:

Vericiguat is a medication being studied for its safety and how well it is tolerated in people with chronic heart failure with reduced ejection fraction. This medication is being tested to see if starting treatment with it is safe and manageable for patients.

Chronic Heart Failure with Reduced Ejection Fraction – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a reduced ejection fraction, which is a measure of how much blood the left ventricle pumps out with each contraction. Over time, the heart becomes weaker, and symptoms such as fatigue, shortness of breath, and fluid retention may develop. The progression of the disease can lead to worsening heart function and increased difficulty in performing daily activities. As the heart struggles to meet the body’s demands, patients may experience episodes of worsening symptoms, known as exacerbations. These exacerbations can lead to hospitalizations and require careful management to stabilize the condition.

Trial ID:
2023-507682-25-00
Protocol code:
21683 “VELOCITY”
Trial Phase:
Therapeutic exploratory (Phase II)

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