Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompen… (NCT03988634) | Clinical Trial Compass
CompletedPhase 3
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
United States467 participantsStarted 2019-06-29
Plain-language summary
The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days post-decompensation.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
âś“. Signed informed consent must be obtained prior to participation in the study
âś“. Patients \>=18 years of age, male or female
âś“. Current hospitalization for Worsening Heart Failure (WHF) (HFpEF decompensation), or within 30 days of discharge following a WHF event (defined as hospitalization, emergency department (ED) visit or out-of-hospital urgent HF visit, all requiring IV diuretics). Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray). Eligible patients were randomized after IV diuresis for HFpEF is given (and no earlier than 36 hours from their last ACEi dose if applicable) and within 30 days post-decompensation after presentation with acute HFpEF decompensation and meeting the following definitions of hemodynamic stability:
âś“. SBP \>=100mmHg for the preceding 6 hours prior to randomization; no symptomatic hypotension
âś“. No increase (intensification) in IV diuretic dose within last 6 hours prior to randomization
âś“. No IV inotropic drugs for 24 hours prior to randomization
âś“. No IV vasodilators including nitrates within last 6 hours prior to randomization
âś“. HFpEF with most recent LVEF \> 40% (within past 3 months)
Exclusion criteria
âś•. Any clinical event within the 90 days prior to randomization that could have reduced the LVEF (i.e., myocardial infarction (MI), coronary artery bypass graft (CABG), unless an echo measurement was performed after the event confirming the LVEF to be \> 40%
What they're measuring
1
Time-averaged Proportional Change in NT proBNP From Baseline to Weeks 4 and 8
✕. Entresto™ (sacubitril/valsartan) usage within the past 60 days
âś•. eGFR \< 20ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization
âś•. Serum potassium \> 5.2 mEq/L at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization
âś•. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to randomization
âś•. Probable alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e. dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity.
âś•. Isolated right HF in the absence of left-sided structural heart disease
âś•. History of hypersensitivity (i.e. including angioedema), known or suspected contraindications, or intolerance to any of the study drugs including ARNIs (i.e. sacubitril/valsartan), and/or ARBs