Heart FailurePhase 2NCT06991257
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
A Phase 2 study testing Low Dose PF-07328948, Medium Dose PF-07328948 and High Dose PF-07328948 in people with Heart Failure, run by Pfizer at 150 sites in 14 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Low Dose PF-07328948, Medium Dose PF-07328948 and High Dose PF-07328948
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 150 sitesin 14 countries
- Study dates
- 19 Jun 2025to 5 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
150 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
150 sites in 14 countries
United States30 sites, 28 recruiting
- Recruiting
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
- Active, not recruiting
National Heart Institute
Beverly Hills, California, 90211
- Recruiting
Chesapeake Cardiac Care
Bowie, Maryland, 20715
- Recruiting
Flourish Research - Bowie
Bowie, Maryland, 20715
- Recruiting
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526
- Recruiting
Valley Regional Medical Center
Brownsville, Texas, 78526
- Recruiting
NMH Clinical Research Unit
Chicago, Illinois, 60611
- Recruiting
Northwestern Memorial HealthCare - Arkes Pavilion
Chicago, Illinois, 60611
- Recruiting
Northwestern Memorial HealthCare - Feinberg Pavilion
Chicago, Illinois, 60611
- Recruiting
Northwestern Memorial HealthCare - Galter Pavilion
Chicago, Illinois, 60611
- Recruiting
Northwestern Memorial Hospital Investigational Drug Service (IDS)
Chicago, Illinois, 60611
- Recruiting
Northwestern University
Evanston, Illinois, 60208
- Recruiting
NexGen Research
Fort Wayne, Indiana, 46804
- Recruiting
Texas Health Physicians Group
Fort Worth, Texas, 76104
- Recruiting
Texas Health Research & Education Institute - Fort Worth
Fort Worth, Texas, 76104
- Recruiting
Chicago Medical Research
Hazel Crest, Illinois, 60429
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
- Active, not recruiting
Orange County Research Center
Lake Forest, California, 92630
- Recruiting
NexGen Research
Lima, Ohio, 45801
- Recruiting
Velocity Clinical Research, Lincoln, Pioneer Heart Institute
Lincoln, Nebraska, 68510
- Recruiting
North Dallas Research Associates
McKinney, Texas, 75069
- Recruiting
Infinite Clinical Research
Miami, Florida, 33133
- Recruiting
Flourish Research Acquisition, LLC dba Flourish Research - North Miami
Miami, Florida, 33138
- Recruiting
Amavita Research Services
North Miami Beach, Florida, 33169
- Recruiting
DBC Research USA, Corp
Pembroke Pines, Florida, 33029
- Recruiting
Reid Physician Associates
Richmond, Indiana, 47374
- Recruiting
Comprehensive Cardiovascular Care
Santa Maria, California, 93454
- Recruiting
FOMAT Medical Research
Santa Maria, California, 93454
- Recruiting
Northwest Houston Heart Center
Tomball, Texas, 77375
- Recruiting
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
Japan19 sites, 19 recruiting
- Recruiting
Tokyo Metropolitan Toshima Hospital
Itabashi-ku, Tokyo, 173-0015
- Recruiting
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, 740-8510
- Recruiting
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510
- Recruiting
Nagoya Tokushukai General Hospital
Kasugai, Aichi-ken, 487-0016
- Recruiting
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042
- Recruiting
Showa General Hospital
Kodaira-shi, Tokyo, 187-8510
- Recruiting
Koga General Hospital
Koga, Ibaraki, 306-0041
- Recruiting
Seikeikai New Tokyo Heart Clinic
Matsudo, Chiba, 271-0077
- Recruiting
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902
- Recruiting
Nagasaki Harbor Medical Center
Nagasaki, 850-8555
- Recruiting
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188
- Recruiting
Teine Keijinkai Hospital
Sapporo, Hokkaido, 006-8555
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520
- Recruiting
NewHeart Watanabe Institute
Suginami, Tokyo, 168-0065
- Recruiting
Sekino Hospital
Toshimaku, Tokyo, 171-0014
- Recruiting
National Hospital Organization Mie Chuo Medical Center
Tsu, Mie-ken, 514-1101
- Recruiting
National Hospital Organization Saitama Hospital
Wako, Saitama, 351-0102
- Recruiting
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 221-0855
- Recruiting
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, 245-8575
Canada14 sites, 13 recruiting
- Recruiting
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
- Recruiting
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 5J1
- Recruiting
ACV Clinic
Greater Sudbury, Ontario, P3E 5M4
- Recruiting
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, B3H 3A7
- Recruiting
CHU de Quebec - Université Laval - Hotel Dieu de Quebec
Québec, Quebec, G1R 2J6
- Active, not recruiting
Richmond Clinical Trials
Richmond, British Columbia, V6V 2L1
- Recruiting
CardioQuest Research Centre
Sarnia, Ontario, N7T 4P5
- Recruiting
Clinique de Médecins Spécialistes
Shebrooke, Quebec, J1E 0N8
- Recruiting
Diex Recherche Sherbrooke Est
Sherbrooke, Quebec, J1E 0N8
- Recruiting
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
Terrebonne, Quebec, J6V 2H2
- Recruiting
Corcare
Toronto, Ontario, M1B 5N1
- Recruiting
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, G9A 4P3
- Recruiting
Community Care Building
Winchester, Ontario, K0C 2K0
- Recruiting
Winchester District Memorial Hospital
Winchester, Ontario, K0C 2K0
Bulgaria13 sites, 12 recruiting
- Recruiting
"Multiprofile Hospital for Active Treatment Puls" AD
Blagoevgrad, 2700
- Recruiting
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
Gabrovo, 5300
- Recruiting
Medical Center Hera - Kyustendil EOOD
Kyustendil, 2500
- Recruiting
Diagnostic Consultative Center - 1 Lom EOOD
Lom, Montana, 3600
- Active, not recruiting
MHAT - Heart and Brain
Pleven, 5804
- Recruiting
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, 4002
- Recruiting
MHAT Hadzhi Dimitar
Sliven, 8800
- Recruiting
Diagnostic Consultative Center "Ascendent"
Sofia, Sofia (stolitsa), 1202
- Recruiting
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia, Sofia (stolitsa), 1233
- Recruiting
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia (stolitsa), 1431
- Recruiting
University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD
Sofia, Sofia (stolitsa), 1431
- Recruiting
Аcibadem City Clinic University MHAT EOOD - Third Clinical Base
Sofia, 1415
- Recruiting
Medical Center Hera EOOD
Sofia, 1510
China13 sites, 13 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
- Recruiting
China-Japan Union Hospital
Changchun, Jilin, 130033
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
- Recruiting
Hainan General Hospital
Haikou, Hainan, 570311
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
Lanzhou university second hospital
Lanzhou, Gansu, 730030
- Recruiting
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
- Recruiting
Tianjin People' s Hospital
Tianjin, Tianjin Municipality, 300000
- Recruiting
Shaanxi provincial people's hospital
Xi'an, Shaanxi, 710068
Spain12 sites, 12 recruiting
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], 08003
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041
- Not yet recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalunya [cataluña], 08907
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, 28046
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28220
- Recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], 15706
- Recruiting
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
- Not yet recruiting
Hospital General Universitario de Valencia
Valencia, 46014
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Brazil10 sites, 10 recruiting
- Recruiting
Cardresearch - Cardiologia Assistencial e Pesquisa
Belo Horizonte, Minas Gerais, 30150-274
- Recruiting
UNESP - Faculdade de Medicina da Universidade Estadual Paulista
Botucatu, SÃO PAUL, 18618-970
- Recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, 70200730
- Recruiting
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, 13060-080
- Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001
- Recruiting
CoraCentro Pesquisa Clinica
Porto Alegre, Rio Grande do Sul, 90840-440
- Recruiting
Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping
Ribeirão Preto, São Paulo, 14026-900
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090000
- Recruiting
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
- Recruiting
Incor - Instituto do Coracao
São Paulo, 05403-000
Argentina7 sites, 7 recruiting
- Not yet recruiting
CEMEDIC
CABA, 1407
- Not yet recruiting
Hospital Privado Universitario de Córdoba
Córdoba, 5016
- Recruiting
Instituto Médico DAMIC
Córdoba, X5003DCE
- Recruiting
DIM Clínica Privada
Ramos Mejía, Buenos Aires, B1704ETD
- Recruiting
Sanatorio Británico
Rosario, Santa Fe Province, S2000CVB
- Not yet recruiting
Corporación Médica San Martín
San Martín, Buenos Aires, 1650
- Recruiting
Centro de Investigaciones Clinicas del Litoral
Santa Fe, S3000FWO
Czechia7 sites, 7 recruiting
- Recruiting
Kardiologicka ambulance Brno s.r.o.
Brno-Královo Pole, 612 00
- Recruiting
EFERTUS healthcare s.r.o.
Brno-Židenice, 615 00
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
- Recruiting
EDUMED s.r.o.
Jaroměř, 551 01
- Recruiting
Sdružené Zdravotnické Zařízení Krnov
Krnov, Moravian-Silesian Region, 794 01
- Recruiting
VASOMED Clinic s.r.o.
Ostrava, 710 00
- Recruiting
AGEL Stredomoravska nemocnicni, a.s., Nemocnice AGEL Prerov
Přerov, 751 52
Hungary7 sites, 7 recruiting
- Recruiting
Ezüstfény Klinika Kft
Budapest, 1106
- Recruiting
Semmelweis Egyetem
Budapest, 1122
- Recruiting
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
Budapest, 1134
- Recruiting
Jahn Ferenc Dél-pesti Hospital
Budapest, 1204
- Recruiting
BKS Research Kft
Hatvan, Heves County, 3000
- Recruiting
Da Vinci Magánklinika
Pécs, Baranya, 7635
- Recruiting
New Medical Center Kft.
Sopron, H-9400
United Kingdom7 sites, 7 recruiting
- Recruiting
South Eastern Health and Social Care Trust
Belfast, BT16 1RH
- Recruiting
St Richard's Hospital
Chichester, WEST Sussex, PO19 6SE
- Recruiting
Ninewells Hospital and Medical School
Dundee, Dundee CITY, DD1 9SY
- Recruiting
Wycombe General Hospital
High Wycombe, HP11 2TT
- Recruiting
St. George's Hospital
London, England, SW17 0QT
- Recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
- Recruiting
Northern General Hospital
Sheffield, S5 7AU
Poland6 sites, 6 recruiting
- Recruiting
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231
- Recruiting
Kardio Brynow
Katowice, Silesian Voivodeship, 40-555
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, 61-848
- Recruiting
SP ZOZ w Puławach
Puławy, Lublin Voivodeship, 24-100
- Recruiting
NZOZ Sopockie Centrum Badan Kardiologicznych Pro Cordis Pawel Miekus
Sopot, Pomeranian Voivodeship, 81-717
- Recruiting
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
France4 sites, 4 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38700
- Recruiting
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, 34090
- Recruiting
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-atlantique, 44800
- Recruiting
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, Provence-Alpes-Côte d'Azur Region, 83100
Puerto Rico1 site, 1 recruiting
- Recruiting
Research and Cardiovascular Corp.
Ponce, 00717
About this study
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN ORAL BRANCHED-CHAIN KETOACID DEHYDROGENASE KINASE INHIBITOR, PF-07328948, IN ADULTS WITH HEART FAILURE (BRANCH-HF)
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).
Read the detailed description
All participants in this study will take either the study medicine (PF-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. The study determines if the study medicine (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard-of-care medications for heart failure that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants will be involved in this study for about 48 weeks. During this time, participants will visit the study clinic 15 times. In general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.
- Conditions
- Heart Failure
- Being tested
- Placebo, Low Dose PF-07328948, Medium Dose PF-07328948, High Dose PF-07328948
- Keywords
- Heart Failure with mildly reduced ejection, Heart Failure with preserved ejection fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
ARM 1
Low Dose PF-07328948Drug
Also called low dose
ARM 2
Medium Dose PF-07328948Drug
Also called medium dose
ARM 3
High Dose PF-07328948Drug
Also called High dose
ARM 4
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Placebo comparator | Placebo Participants will receive Placebo for up to 36 weeks Receives: Drug: Placebo |
| ARM 2 | Experimental | Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks Receives: Drug: Low Dose PF-07328948 |
| ARM 3 | Experimental | Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks Receives: Drug: Medium Dose PF-07328948 |
| ARM 4 | Experimental | High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks Receives: Drug: High Dose PF-07328948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinical Events
Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
Measured: over 36 weeks
Change From Baseline in 6-Minute Walk Test (6MWD)
A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
Measured: Baseline, week 36 post-dose
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)
KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.
Measured: Baseline, week 36
Secondary outcomes (6)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE that, at any dose, results in 1 or more of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.
Measured: Baseline, up to week 40
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Symptom Score (KCCQ-23 TSS) and physical limitation in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.
KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores are also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, Social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status.
Measured: Baseline, week 36
Change From Baseline in 6-minute walk test distance (6MWD) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.
A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
Measured: Baseline, week 36
CPET Substudy) : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36
Cardiopulmonary exercise testing
Measured: Baseline, Week 36
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36
NT-proBNP is a biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).
Measured: Baseline, Week 36
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall clinical symptom Score (KCCQ-23 CSS) and physical limitation) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.
KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores are also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status.
Measured: Baseline, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start19 Jun 2025
- Primary completion8 May 2028 (estimated)
- Study completion5 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991257
- Sponsor's protocol ID
- C4921003
- Other IDs
- 2024-518438-94-00
- Status last verified
- Oct 2026
- First submitted
- 19 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.