Tests baxdrostat with dapagliflozin to prevent heart failure in people with diabetes
Tests baxdrostat added to dapagliflozin in adults with type 2 diabetes and heart disease.
Key facts
- Who runs it
- AstraZeneca
- Where
- Aachen, Amberg, Bad Oeynhausen, Bamberg, Bechhofen, Berlin, Bochum, Brandenburg An Der Havel, Bremen, Deggingen, Dresden, Elsterwerda, Essen, Frankfurt am Main, Freiburg im Breisgau, Friedrichsthal, Fulda, Gelnhausen, Goerlitz, Hamburg, Hassloch, Heidelberg, Homburg, Kaiserslautern, Kassel, Koeln, Langen (Hesse), Leipzig, Ludwigshafen Am Rhein, Mannheim, Markkleeberg, Neuruppin, Nittendorf, Obertshausen, Oldenburg in Holstein, Osnabrück, Papenburg, Pirna, Ratingen, Reinfeld, Wallerfing, and Weinheim, GermanySee the 55 sitesAlso in 34 other countries, 766 sites
- Trial code
- Registry title
- Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 11,300 people, planned
- Started
- 14 Mar 2025
- Expected to end
- 17 Dec 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Baxdrostat and dapagliflozin
- Placebo and dapagliflozin
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with type 2 diabetes, heart or blood vessel disease, and high blood pressure, who do not yet have heart failure but have extra risk factors for it.
- Age
- 40 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes needing treatment, established heart or blood vessel disease (ischaemic heart disease, cerebrovascular disease or peripheral arterial disease), history of high blood pressure with SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at randomisation, and at least one more risk factor for heart failure (age ≥ 70 years, UACR > 20 mg/g, eGFR < 60 mL/min/1.73 m2, polyvascular disease, atrial fibrillation or flutter, or NT-proBNP > 125 ng/L).
- Earlier treatment
- People not taking an SGLT2 inhibitor, or taking one for less than 4 weeks, first take dapagliflozin 10 mg once daily for at least 4 weeks (not more than 6 weeks) before randomisation.
- Biomarker or test result
- Serum potassium must be within the level set by the study. Blood pressure, UACR, eGFR and NT-proBNP values are listed under disease stage.
Main reasons for not taking part
- Heart failure already diagnosed and treated
- eGFR < 30 mL/min/1.73 m2 at screening
- Known high potassium (≥ 5.5 mmol/L) within 3 months before screening
- Type 1 diabetes, or uncontrolled type 2 diabetes with HbA1c > 10.5% (91 mmol/mol)
- Dialysis or acute kidney injury within 3 months before screening
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent
- Diagnosed with T2DM and requiring treatment
- Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit
- At least one additional risk factor for HF:; Age ≥ 70 years; UACR > 20 mg/g; eGFR < 60 mL/min/1.73 m2; History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease); History of atrial fibrillation or atrial flutter; NT-proBNP > 125 ng/L
Who cannot take part
- Previously confirmed diagnosis and treatment of heart failure
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
- Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
- Percutaneous coronary intervention within 1 month prior to randomisation
- Any dialysis (including for acute kidney injury) within 3 months prior to screening
- Any acute kidney injury within 3 months prior to screening
- Prohibited concomitant medications
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- Documented history of adrenal insufficiency
- An eGFR < 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening
- Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment
Where in Germany
Also in 34 other countries, 766 sites
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- Versdias GmbHAmberg, GermanyTaking people
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet BochumBad Oeynhausen, GermanyTaking people
- CIMS Studienzentrum Bamberg GmbHBamberg, GermanyTaking people
- Ärzte BechhofenBechhofen, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Diabetespraxis Dr. BraunBerlin, GermanyTaking people
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbRBerlin, GermanyTaking people
- SKP Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbHBerlin, GermanyTaking people
- Diabetes- und Stoffwechselpraxis BochumBochum, GermanyTaking people
- Siteworks GmbHBochum, GermanyTaking people
- Dr. Zerbaum & Kollegen MVZ GbRBrandenburg An Der Havel, GermanyTaking people
- Universitaetsklinikum Brandenburg an der Havel GmbHBrandenburg An Der Havel, GermanyTaking people
- Cardio Consult GbRBremen, GermanyTaking people
- Medizinisches Versorgungszentrum Jung GbRDeggingen, GermanyTaking people
- Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbHDresden, GermanyTaking people
- Zentrum fuer klinische Studien Suedbrandenburg GmbHElsterwerda, GermanyTaking people
- InnoDiab Forschung GmbhEssen, GermanyTaking people
- Klinisches Forschungszentrum Dr. HagemannEssen, GermanyTaking people
- Medizentrum Essen BorbeckEssen, GermanyTaking people
- Studienzentrum BocholderstrasseEssen, GermanyTaking people
- ClinPhenomics CVC GmbHFrankfurt am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Gemeinschaftspraxis Dres. Denger & PfitznerFriedrichsthal, GermanyTaking people
- MVZ im Altstadt-Carree Fulda GmbHFulda, GermanyTaking people
- MVZ Diabeteszentrum Dr. Tews GmbHGelnhausen, GermanyTaking people
- Staedtisches Klinikum Goerlitz gGmbHGoerlitz, GermanyTaking people
- Cardiologicum Hamburg GbRHamburg, GermanyTaking people
- Diabetes Zentrum Hamburg WestHamburg, GermanyTaking people
- Diabetes Zentrum Wilhelmsburg GbRHamburg, GermanyTaking people
- Kardiologie am Tibarg - StudiengesellschaftHamburg, GermanyTaking people
- Gemeinschaftspraxis PD Dr. med. habil. Holger Kittner und Dr. HartigHassloch, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaetsklinikum des Saarlandes AöRHomburg, GermanyTaking people
- Kardiopraxis SchirmerKaiserslautern, GermanyTaking people
- B. Braun Ambulantes Herzzentrum Kassel MVZ GmbHKassel, GermanyTaking people
- Praxis für Innere Medizin, Kardiologie, PneumologieKoeln, GermanyTaking people
- Asklepios Kliniken Langen-Seligenstadt GmbHLangen (Hesse), GermanyTaking people
- Diabetologische Schwerpunktpraxis - BAG Dr. Täschner/ Dr. BonigutLeipzig, GermanyTaking people
- Familienmedizinisches Zentrum RadowskyLeipzig, GermanyTaking people
- POIS Sachsen GmbHLeipzig, GermanyTaking people
- Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen Am Rhein, GermanyTaking people
- ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH MannheimMannheim, GermanyTaking people
- Praxis für Innere Medizin und Kardiologie, AngiologieMarkkleeberg, GermanyTaking people
- Ruppiner Kliniken GmbHNeuruppin, GermanyTaking people
- Gemeinschaftspraxis NittendorfNittendorf, GermanyTaking people
- Rahman & Detho Studien GmbHObertshausen, GermanyTaking people
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, GermanyTaking people
- Institut für Diabetesforschung OsnabrückOsnabrück, GermanyTaking people
- Dr. med. Andreas Wilke Dr. med. Andrej Malazhavy und Detelin Lalev Denchev Fachaerzte Innere Medizin und Kardiologie PartnerschaftPapenburg, GermanyTaking people
- Hausarztpraxis/Diabetologische SchwerpunktpraxisPirna, GermanyTaking people
- Sanos Clinic GmbHRatingen, GermanyTaking people
- Praxis Reinfeld MitteReinfeld, GermanyTaking people
- Gemeinschaftspraxis Drs. GrosskopfWallerfing, GermanyTaking people
- GRN Gesundheitszentren Rhein-Neckar gGmbHWeinheim, GermanyTaking people
About the trial
What the trial wants to find out
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.
Read full original descriptionShow less
The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.
Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.
Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.
In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
The 2 groups in the trial
- Baxdrostat/DapagliflozinTreatment being tested
Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Treatment: Baxdrostat and dapagliflozin
- Placebo/DapagliflozinTreatment being tested
Patients will receive a dose of dapagliflozin in combination with matching placebo
Treatment: Placebo and dapagliflozin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
- Plain-language title
- Tests baxdrostat with dapagliflozin to prevent heart failure in people with diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 October 2026