Recruiting NCT06677060

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

Phase III Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Baxdrostat and dapagliflozin, Placebo and dapagliflozin.
Who it may be relevant to: Registry conditions: Heart Failure. Basic parameters: from 40 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Bulgaria +30
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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. 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.

Interventions

Drug Baxdrostat and dapagliflozin
baxdrostat tablet and dapagliflozin tablet
Other Placebo and dapagliflozin
placebo tablet and dapagliflozin tablet

Primary outcome measures

To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death [Time frame: Event driven; Up to 38 months]

Secondary outcome measures (5)

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death [Time frame: Event driven; Up to 38 months]
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events [Time frame: Event driven; Up to 38 months]
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death [Time frame: Event driven; Up to 38 months]
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality [Time frame: Event driven; Up to 38 months]
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of 4-point MACE (CV death, MI, stroke, and hospitalisation for HF) [Time frame: Event driven; Up to 38 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Previously confirmed diagnosis and treatment of heart failure
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
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
Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
Documented history of adrenal insufficiency
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Prevention