Clinical Trials

Inclusion Criteria:

* Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for ≥30 days prior to the index event. Medical records, discharge notes and physician referral letters may serve as documentation for prior chronic treatment with a loop diuretic.

* Experienced an index event, defined as a recent hospitalization for HF requiring ≥2 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥2 bolus doses of intravenous diuretics.
* Chronic HF diagnosed for at least 3 months before V1 (screening)
* Documented LVEF of ≥50% within 12 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT).
* Evidence of documentation of LVEF of ≥50% may also include participant medical records, discharge notes or a referral letter from the participant's physician or referring physician that details the participant's medical history.
* Had evidence of clinical HF syndrome consisting of

* Hospitalization for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following:
* dyspnea
* jugular venous distention
* pitting edema in lower extremities (\>1+)
* ascites
* pulmonary congestion on chest X-ray
* pulmonary rales AND participant received treatment with IV diuretics.

OR

* Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following:

* dyspnea
* jugular venous distention
* pitting edema in lower extremities (\>1+)
* ascites
* pulmonary rales on lung examination.
* NT-proBNP (\>300 \[sinus rhythm\] or 900 picograms/milliliter (pg/mL) \[atrial fibrillation or atrial flutter\] OR brain natriuretic (BNP) (\>100 \[sinus rhythm\] or 300 pg/mL \[atrial fibrillation or atrial flutter\]) at screening.

Note: The presence or absence of atrial fibrillation or atrial flutter to determine the appropriate cut-off for a given BNP or NT-proBNP sample should be evaluated using electrocardiogram (ECG) performed at screening prior to the collection of the BNP or NT-proBNP sample.

Exclusion Criteria

* Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months.
* Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to day 2. (randomization), or any other cardiac surgery planned during the study.
* Have had Left Ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study.
* Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy.
* Have severe chronic obstructive pulmonary disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
* Uncorrected thyroid disease.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/02/2024. Questions regarding updates should be directed to the study team contact.