Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia
Not recruiting
Study on the Effects of Ponsegromab on Quality of Life and Safety in Adults with Heart Failure
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a new treatment for heart failure, a condition where the heart is unable to pump blood effectively. The treatment being tested is called Ponsegromab (PF-06946860), which is a type of protein designed to target specific factors in the body that may affect heart function. The study will compare the effects of Ponsegromab with a placebo to understand its impact on symptoms, daily functioning, and overall quality of life for people with heart failure.
The purpose of the study is to evaluate how Ponsegromab affects the health status of participants with heart failure. Participants will receive repeated doses of the treatment through injections under the skin over a period of time. The study will monitor changes in participants' health and any side effects that may occur. The trial aims to provide insights into how this new treatment could potentially improve the lives of those living with heart failure.
Throughout the study, participants will be assessed on various aspects of their health, including their ability to perform daily activities and their experience of symptoms like fatigue. The study will last for several months, and participants will have regular check-ups to track their progress and ensure their safety. This research is an important step in finding new ways to manage and treat heart failure, potentially offering new hope for patients in the future.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- Participants must be **18 years or older**. Women must not be pregnant or breastfeeding.
- Must have **clinical evidence of heart failure (HF)**, which includes:
- **LVEF (Left Ventricular Ejection Fraction)** less than 50% on the most recent measurement within the last 12 months. LVEF is a measure of how well the heart pumps blood.
- **NYHA class II-IV** at screening. This is a classification of the severity of heart failure symptoms, with class II being mild and class IV being severe.
- For the main group: **NT-proBNP** level of 400 pg/mL or higher at screening. NT-proBNP is a blood test that helps diagnose heart failure.
- **Serum GDF-15 concentration** of 2000 pg/mL or higher at screening. This is a blood test that measures a specific protein level.
- For the main group: **KCCQ-23 CSS** score less than 75 at screening. This is a questionnaire that measures the impact of heart failure on a person's life.
- For the main group: Must show signs of **cachexia** (weight loss and muscle wasting), **fatigue**, or **functional impairment**, demonstrated by at least one of the following:
- Unintentional weight loss of 5% or more in the last 6 months or a **BMI (Body Mass Index)** less than 20 kg/m², along with feelings of tiredness or loss of appetite.
- Feeling tired at least 3 times a week and finding it at least moderately bothersome in the past 2 weeks, based on the KCCQ-23 questionnaire.
- A score of less than 60 on the Physical Limitations section of the KCCQ-23 questionnaire.
- Participants must be willing and able to follow all study requirements, including attending scheduled visits, following the treatment plan, undergoing laboratory tests, and receiving study injections.
Who cannot join the trial?
3 criteria
- Participants with a history of **heart failure** cannot join the study. Heart failure is a condition where the heart doesn't pump blood as well as it should.
- Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it means that only people of certain ages can participate.
- Participants who belong to certain vulnerable groups may not be eligible. Vulnerable groups can include people who might need extra care or protection.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Responsive Responsive Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, SpainResponsive Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Bad Oeynhausen, Germany
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Ponsegromab is a medication being studied for its potential benefits in treating heart failure. In this clinical trial, it is administered through injections under the skin. The goal is to see if it can improve symptoms, daily functioning, and overall quality of life for people with heart failure. Researchers are also monitoring its safety to ensure it is a suitable treatment option.
What is already known about the treatment
Ponsegromab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effects on heart failure. It is in the investigational stage, with ongoing research to determine its efficacy and safety. The main therapeutic indication for ponsegromab is the treatment of heart failure, aiming to improve symptoms and quality of life for patients. At the molecular level, ponsegromab works by targeting specific pathways involved in heart function, although the exact mechanism is still under investigation. It is classified pharmacologically as a monoclonal antibody, designed to interact with specific proteins in the body to exert its effects.
Investigated diseases
Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying issues, such as coronary artery disease or high blood pressure, which weaken or stiffen the heart muscle. As the condition progresses, individuals may experience symptoms like shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart's reduced ability to pump blood can lead to fluid buildup in the lungs and other parts of the body. This can cause persistent coughing or wheezing and increased difficulty in performing physical activities. Heart failure is a chronic condition that typically worsens over time, requiring ongoing management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509747-27-00Protocol codeC3651011Estimated enrolment477 patientsSponsorPfizer Inc.
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?