Study on the Effects of Ponsegromab on Quality of Life and Safety in Adults with Heart Failure

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What is this study about?

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.

1 joining the study

Upon joining the study, participants are randomly assigned to one of four groups. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo.

Participants must meet specific criteria, including being 18 years or older and having clinical evidence of heart failure.

2 treatment administration

Participants receive either ponsegromab or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous use).

The treatment is given repeatedly over the course of the study. The exact schedule and dosage are determined by the study protocol.

3 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor their health status and the effects of the treatment.

These assessments include changes in heart failure symptoms, physical limitations, and overall health-related quality of life.

4 end of treatment evaluation

At the end of the treatment period, participants’ health status is evaluated to determine any changes from the beginning of the study.

The primary focus is on the change in heart failure-specific health status at Week 22.

5 follow-up

Participants may be required to attend follow-up visits to ensure their well-being and to gather additional data on the long-term effects of the treatment.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha	Prague	Czechia
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum	Bad Oeynhausen	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH	Dresden	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
TaNa Med Kft.	Mosonmagyaróvár	Hungary
Consorci Mar Parc De Salut De Barcelona	Barcelona	Spain
Kardio Brynow Sp. z o.o.	Katowice	Poland
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Semmelweis University	Budapest	Hungary
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Medifarma-98 Kft.	Nyiregyhaza	Hungary
University Of Pecs	Pecs	Hungary
Edumed s.r.o.	Nachod	Czechia
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Iqvbznvtw Fci Ckpsdxrj Aje Ecbfwkpjxpvp Mwdkixcf	Prague	Czechia
Pmxqxjbrel Kwwq	Bekescsaba	Hungary
Ktuuthyy Ddeunipi Kolcjl	Nagykanizsa	Hungary
Bwvyhyncfpx Vtqlageer Olsozsfevbfl	Kecskemet	Hungary
Bzjzftkdko Ickhltzkxzlf Bkvcz Itsjpxttlrdes Krerex	Budapest	Hungary
Geyzka Uozvboibuv Fdmwpznih	Frankfurt	Germany
Hjezoyuf Dv Lx Sqgju Cphd I Svln Pxo	Barcelona	Spain
Fpgxvwoab Phkr Lf Iatpuewufuejj Bisucbqvb Doa Hmfynntn Uhoydrofzczna Lc Pug	Madrid	Spain
Mvmmyye Spobtws Zxzijbbwn w Oxmhtwmfy	Olsztyn	Poland
Hwpxqozh Vurm duevjuec	Barcelona	Spain
Htncdjni Uvmwmsmumdbwx de A Cgunsl	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	26.09.2022
Germany	Not recruiting	26.09.2022
Hungary	Not recruiting	26.09.2022
Poland	Not recruiting	26.09.2022
Spain	Not recruiting	26.09.2022

Trial locations

Investigated drugs:

Ponsegromab

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.

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 ID:

2023-509747-27-00

Protocol code:

C3651011

NCT ID:

NCT05492500

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Ponsegromab on Quality of Life and Safety in Adults with Heart Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?