A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling
The goal of this trial is to learn whether adding the blood pressure medication baxdrostat (Baxfendy) to standard-of-care medical therapies will beneficially change the heart structure and function of adults who have high blood pressure, thickened left heart walls, and are at risk for heart or kidney disease.
To determine if baxdrostat improves heart structure and function, the participants will:
The BaxREMODEL CardioLink-18 Research Study is a multicentre, prospective, randomized, double-blind, parallel research study of baxdrostat vs placebo in addition to standard-of-care in adults with a history of hypertension and either cardiovascular or cardiorenal risk factors plus evidence of left ventricular hypertrophy or increased left ventricular mass. A total of 286 individuals will be assigned (1:1) to receive either baxdrostat 2 mg or placebo QD for 12 months.
INCLUSION CRITERIA
Individuals ≥18 years of age who are willing and able to provide signed informed consent
History of hypertension (Systolic BP >140 and <170 mmHg)
Serum K+ ≥3.5 and <5.0 mmol/L at Screening
Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:
The presence of ≥1 of the following risk factors:
Female individuals who are of childbearing age can only be considered eligible if:
EXCLUSION
Considered unsuitable by the investigator for any reason that may either place the participant at increased risk during participation or interfere with the interpretation of the study outcomes
Female individuals who are pregnant, or can get pregnant, are breast-feeding or are planning to breastfeed and are/will not be using at least one highly effective contraception method (see Inclusion Criteria section for definitions) during the 30 days before Randomization, throughout the research study, and for at least 30 days after taking the last dose of the assigned IP
Upper arm circumference <18 cm or >43 cm at Screening
Body mass index >40 kg/m^2 (Image quality and accurate assessment of cardiac function degrades with obesity across all imaging modalities. Although CMR-derived images are the least compromised by high body mass indexes, MRI bore sizes and table weight limits, greater safety risks [eg. thermal burns] as well as increased frequencies of claustrophobia remain major challenges.
Contraindication or inability to undergo CMR scan
Serum Na+ level <135 mmol/L at Screening
A1C >10% if living with T2DM during the 30 days before Randomization
At Screening
At Screening or first IP intake
Medical history
Surgical history
Prior treatment (within 30 days before Screening) with or currently on an angiotensin-receptor blocker (ARB) in combination with an angiotensin converting enzyme inhibitor (ACEi)
Prior treatment (within 30 days before Screening) with or currently on a mineralocorticoid receptor antagonist (MRA) or a K+-sparing diuretic, or anticipated initiation of either of these agents during the study period
Unwilling to discontinue taking K+ supplements
On K+ binders within 30 days prior to Screening
On or expected to initiate a strong cytochrome P450 3A (CYP3A) inducer (eg. carbamazepine, enzalutamide, mitotane, phenytoin, rifabutin, rifampin and St. John's wort)
Prior treatment within 6 months prior to Screening with a cytotoxic therapy (eg. cisplatin, doxorubicin, etoposide, misoprostol, trastuzumab)
Known hypersensitivity to baxdrostat or drugs of the same class or any of its excipients
Participation in another clinical study involving the investigational drug within 30 days prior to Screening or has plans to participate in another clinical study within 30 days of discontinuing the investigational drug
subodh.verma@nydcc.ca416-864-5997
subodh.verma@nydcc.ca416-291-7300