Study of PF-07328948 tablets compared to placebo in adults with heart failure to evaluate effects on symptoms and physical function

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What is this study about?

This study focuses on people with Heart Failure, a condition where the heart cannot pump blood effectively throughout the body. The study will test a new medication called PF-07328948, which is taken as tablets by mouth. Some participants will receive the actual medication while others will receive a placebo. The purpose is to evaluate how well this new drug works and how safe it is for adults with heart failure when taken daily for 36 weeks.

The study will look at patients who have a specific type of heart failure where the heart’s ability to pump blood is only mildly reduced or preserved. Participants must have certain signs of heart failure, including elevated pressure in the heart chambers or previous hospital visits for heart failure symptoms. The study will measure how the treatment affects important aspects of the condition, such as physical function and quality of life.

Throughout the study, researchers will track any heart-related events, measure how far participants can walk in 6 minutes, and assess how participants feel in their daily activities. They will also monitor the levels of substances in the blood that indicate heart stress and keep track of any side effects that may occur during treatment. All participants must also be taking another type of medication called an SGLT2 inhibitor before and during the study.

1 Initial screening visit

During the first visit, your basic health parameters will be checked, including blood tests, body mass index (BMI), and heart function tests

A special test called 6-minute walk test will be performed to measure your physical ability

You will complete a questionnaire about your heart failure symptoms

2 Heart examination

An echocardiogram (heart ultrasound) will be performed to check your heart function

The test will measure your heart’s pumping ability and structure

3 Medication assignment

You will be randomly assigned to receive either PF-07328948 tablets or placebo tablets

The medication or placebo will be taken orally each day

You must continue taking your current heart medication, including SGLT2 inhibitor (a type of diabetes medication that also helps with heart failure)

4 Treatment period

The treatment will continue for 36 weeks

Regular check-ups will be scheduled to monitor your health

Your heart function, physical ability, and quality of life will be assessed throughout the study

5 Final assessment

At week 36, final tests will be performed, including:

Another 6-minute walk test to measure changes in physical ability

Blood tests to check heart failure markers

Quality of life questionnaire completion

For some participants: a special exercise test to measure oxygen use during activity

Who Can Join the Study?

  • Must be aged 18 years or older (up to 80 years in EU)
  • Must have been diagnosed with chronic heart failure for at least 3 months
  • Must have a Body Mass Index (BMI) of 27.0 to 50.0, or lower BMI if you have type 2 diabetes, are using specific medications, or have increased waist circumference (over 37 inches for men or 31 inches for women)
  • Must be receiving SGLT2i therapy (a type of diabetes medication) for at least 30 days before starting the study
  • Must have specific heart measurements showing:
    • Heart pumping function (ejection fraction) above 40%
    • Certain structural heart changes if ejection fraction is 50% or higher
  • Must have at least one of these conditions:
    • Elevated levels of specific heart proteins in blood tests
    • Evidence of increased heart pressure in previous tests
    • Recent hospital stay for heart failure treatment
    • Recent urgent care visit for heart failure treatment
  • Must be able to walk at least 75 meters in a 6-minute walking test
  • Must have specific blood sugar levels (HbA1c) between 5.7% and 10.0%
  • Women who can become pregnant must:
    • Have a negative pregnancy test
    • Agree to use effective birth control
    • Not be breastfeeding
  • Must sign an informed consent form
  • Must be willing to attend all study visits and complete all required procedures

Who Cannot Join the Study?

  • History of severe allergic reactions to medications or multiple drug allergies
  • Current pregnancy or breastfeeding
  • Severe kidney disease requiring dialysis (a medical procedure to filter blood when kidneys don’t work properly)
  • Severe liver disease (conditions that significantly affect liver function)
  • Recent heart attack or stroke (within the last 3 months)
  • Active or recent cancer treatment within the past year
  • Participation in other clinical trials within the last 30 days
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Unable to provide informed consent (understanding and agreeing to participate in the study)
  • Blood disorders that increase risk of bleeding
  • Life expectancy less than 12 months due to other medical conditions
  • Unable to take medications by mouth
  • History of not following medical treatment plans

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 Y Politecnico La Fe Valencia Spain
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Sliven Bulgaria
Donmed s.r.o. Ostrava Czechia
CHU Grenoble Alpes La Tronche France
NZOZ „Pro Cordis” Sopockie Centrum Badań Kardiologicznych Paweł Miękus Sopot Poland

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Medical Center Hera EOOD Sofia Bulgaria
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
BKS Research Kft. Hatvan Hungary
Diagnostic Consultative Center 1 Lom EOOD Lom Bulgaria
Kardio Brynow Sp. z o.o. Katowice Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Pulawy Poland
Complex Rendelo Med Zrt. Szekesfehervar Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Kardiologicka ambulance Brno s.r.o. Brno Czechia
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital General Universitario De Valencia Valencia Spain
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Centre Hospitalier Universitaire De Nantes Nantes France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet Budapest Hungary
Edumed s.r.o. Nachod Czechia
Infer-Med Kft. Pecs Hungary
Miejski Szpital Zespolony W Olsztynie Olsztyn Poland
Siremafc zvlyygldrmtl zgeolqem Kktrq popjyqgtdab oeiuesvcth Krnov Czechia
Eiohipn hscteuyibo sanbud Brno Czechia
Asvs Szzwjamqjpymkc naeiroeyfh agrm Prerov Czechia
Mcuccit Cixplf Daz Mutcxtkw Edik Kyustendil Bulgaria
Hzykknsb Dm Lh Sjgce Cxpr I Slat Phv Barcelona Spain
Fblgpvkls Phsv Lh Ixcpikhszoslq Bssyjrfgt Ddj Haggepkm Uujcanadcmgqv Li Pxz Madrid Spain
Ncf Maxpylq Cufsuj Kqxw Sopron Hungary
Hvgrjoft Voyd dtojakwv Barcelona Spain
Esvdzotbz Khggwck Klhy Budapest Hungary

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
19.11.2025
Czechia Czechia
Recruiting
19.11.2025
France France
Recruiting
19.11.2025
Hungary Hungary
Recruiting
19.11.2025
Poland Poland
Recruiting
19.11.2025
Spain Spain
Recruiting
19.11.2025

Trial locations

PF-07328948 is an oral branched-chain ketoacid dehydrogenase kinase inhibitor being studied for the treatment of heart failure. This medication is designed to help patients who have heart failure with mildly reduced or preserved ejection fraction (types of heart failure where the heart’s ability to pump blood is affected). The medication is taken by mouth and aims to improve physical function and symptoms in people with heart failure while potentially reducing cardiovascular-related events.

Investigated diseases:

Heart Failure – A chronic condition where the heart cannot pump blood effectively enough to meet the body’s needs. The heart muscle becomes weaker over time or has difficulty filling with blood. This leads to symptoms such as shortness of breath, fatigue, and fluid retention in various parts of the body, particularly the legs and lungs. Heart failure can develop gradually as the heart tries to compensate for its weakening function by enlarging, developing more muscle mass, or pumping faster. The condition can affect either the left side, right side, or both sides of the heart.

Trial ID:
2024-518438-94-00
Protocol code:
C4921003
NCT ID:
NCT06991257
Trial Phase:
Therapeutic exploratory (Phase II)

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