A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
Recruiting · NCT06991257 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
High Dose PF-07328948Low Dose PF-07328948Medium Dose PF-07328948Placebo
What this trial is about
The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).
Who can take part
Age range
18 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- include:
- aged 18 years to \< 80 years
- clinically confirmed to have a diagnosis of heart failure for at least 3 months
- New York Heart Association Class II-IV symptoms
- left ventricular ejection fraction greater than 40%
- Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score \< 85
- Six-minute walking distance greater than 75 meters
- Key
Exclusion criteria
- include:
- Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
- Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.
- History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
- Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor
Where it is running
60 locations listed across 8 US states.
- National Heart Institute - Beverly Hills, California, United States
- Orange County Research Center - Lake Forest, California, United States
- Comprehensive Cardiovascular Care - Santa Maria, California, United States
- FOMAT Medical Research - Santa Maria, California, United States
- FWD Clinical Research - Boca Raton, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- Infinite Clinical Research - Miami, Florida, United States
- Flourish Research Acquisition, LLC dba Flourish Research - North Miami - Miami, Florida, United States
- Amavita Research Services - North Miami Beach, Florida, United States
- Clinical Site Partners, LLC dba Flourish Research - Winter Park, Florida, United States
- NMH Clinical Research Unit - Chicago, Illinois, United States
- Northwestern Memorial HealthCare - Arkes Pavilion - Chicago, Illinois, United States
- Northwestern Memorial HealthCare - Feinberg Pavilion - Chicago, Illinois, United States
- Northwestern Memorial HealthCare - Galter Pavilion - Chicago, Illinois, United States
- Northwestern Memorial Hospital Investigational Drug Service (IDS) - Chicago, Illinois, United States
- Northwestern University - Evanston, Illinois, United States
- Chicago Medical Research - Hazel Crest, Illinois, United States
- NexGen Research - Fort Wayne, Indiana, United States
- Reid Physician Associates - Richmond, Indiana, United States
- Ascension Saint Agnes Heart Care - Baltimore, Maryland, United States
- Chesapeake Cardiac Care - Bowie, Maryland, United States
- Flourish Research - Bowie - Bowie, Maryland, United States
- Velocity Clinical Research, Lincoln, Pioneer Heart Institute - Lincoln, Nebraska, United States
- NexGen Research - Lima, Ohio, United States
- Headlands Horizons, LLC dba Headlands Research-Brownsville - Brownsville, Texas, United States
- Valley Regional Medical Center - Brownsville, Texas, United States
- North Dallas Research Associates - McKinney, Texas, United States
- Northwest Houston Heart Center - Tomball, Texas, United States
- South Eastern Health and Social Care Trust - Belfast, United Kingdom
- "Multiprofile Hospital for Active Treatment Puls" AD - Blagoevgrad, Bulgaria
- Kardiologicka ambulance Brno s.r.o. - Brno-Královo Pole, Czechia
- EFERTUS healthcare s.r.o. - Brno-Židenice, Czechia
- Ezüstfény Klinika Kft - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Eszak-Pesti Centrumkorhaz-Honvedkorhaz - Budapest, Hungary
- Jahn Ferenc Dél-pesti Hospital - Budapest, Hungary
- Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD - Gabrovo, Bulgaria
- Chu Grenoble Alpes - Grenoble, France
- The First Affiliated Hospital of University of South China - Hengyang, China
- Wycombe General Hospital - High Wycombe, United Kingdom
- Fakultni nemocnice Hradec Kralove - Hradec Králové, Czechia
- EDUMED s.r.o. - Jaroměř, Czechia
- Medical Center Hera - Kyustendil EOOD - Kyustendil, Bulgaria
- Nagasaki Harbor Medical Center - Nagasaki, Japan
- VASOMED Clinic s.r.o. - Ostrava, Czechia
- MHAT - Heart and Brain - Pleven, Bulgaria
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD - Plovdiv, Bulgaria
- Research and Cardiovascular Corp. - Ponce, Puerto Rico
- AGEL Stredomoravska nemocnicni, a.s., Nemocnice AGEL Prerov - Přerov, Czechia
- MHAT Hadzhi Dimitar - Sliven, Bulgaria
- Аcibadem City Clinic University MHAT EOOD - Third Clinical Base - Sofia, Bulgaria
- Medical Center Hera EOOD - Sofia, Bulgaria
- New Medical Center Kft. - Sopron, Hungary
- CEPIC - Centro Paulista de Investigação Clínica - São Paulo, Brazil
- Incor - Instituto do Coracao - São Paulo, Brazil
- Hospital General Universitario de Valencia - Valencia, Spain
- Hospital Universitari i Politecnic La Fe - Valencia, Spain
- CHUS - Hospital Clinico Universitario - Santiago de Compostela, A Coruña [LA Coruña], Spain
- Kasugai Municipal Hospital - Kasugai, Aichi-ken, Japan
- Nagoya Tokushukai General Hospital - Kasugai, Aichi-ken, Japan
Showing 60 of 142 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →