Cardiovascular Risk in Hypertension and Diabetes

Patients gave written informed consent to participate in the study before any study-related assessments were performed. Patients 40 years and older with systemic hypertension (medicated for more than 1 month) and/or type 2 diabetes were included and had the following at screening or within 6 months prior to screening: elevated blood B-type natriuretic peptide (BNP; 20 pg/mL to 280 pg/mL) or N-terminal pro b-type natriuretic peptide (NT-proBNP; 100 pg/ml to 1000 pg/mL); and enlarged transthoracic left atrial volume index (LAVI; >28 mL/m² obtained using echocardiography).^{22 (link)} As detailed in the protocol, we reduced the entry BNP and LAVI thresholds early in the study from 35 pg/mL and 34 mL/m² respectively to include a low-risk population, based on the observation that almost 3 in 10 major adverse cardiovascular events in the original STOP-HF trial^{2 (link)} occurred in patients with baseline BNP in the range of 20 to 49 pg/mL. Detailed inclusion and exclusion criteria are provided in eTable 1 in Supplement 2. Patients were ineligible if they had a history of or any features of symptomatic heart failure, left ventricular systolic dysfunction (ejection fraction <50%), or serious valvular disease or kidney dysfunction.