Status:
COMPLETED
Treatment of PH With Angiotensin II Receptor Blocker and Neprilysin Inhibitor in HFpEF Patients With CardioMEMS Device
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the impact of sacubitril/valsartan on elevated pulmonary artery (PA) pressures in patients with heart failure (HF) with preserved ejection fraction (HFpEF), measured using a pre...
Detailed Description
Fluid overload leading to increased PA pressure is one of the primary causes of HF related hospitalizations in HFpEF. Signs and symptoms of fluid overload are not sensitive enough to reflect early pat...
Eligibility Criteria
Inclusion
- Patients able to provide written informed consent.
- Patients ≥18 years of age, male or female, in NYHA Class II- III HFpEF with LVEF \> 45% (measured within the past year), and who have no previous LVEF\<45%.
- NT-proBNP \>200 pg/ml if HF hospitalization in the previous 9 months and\> 300 pg/ml if there was no previous HF hospitalization; Three times the values were required in patients with atrial fibrillation.
- CardioMEMS HF System implanted and patient transmitting information regularly and system functioning appropriately.
- Average PAPm \>20mm Hg during the 7 days prior to enrollment, including at least 5 daily measurements.
- Systolic BP \> 100 mm Hg at most recent clinical assessment.
- Stable, ambulatory patients without the need for change in diuretics and other HF drugs during last week.
Exclusion
- eGFR \< 30 ml/min/1.73 m2 as measured by CKD-EPI.
- Sacubitril/Valsartan treatment within the past 30 days.
- History of hypersensitivity, intolerance or angioedema to previous renin-angiotensin system (RAS) blocker, ACE inhibitor, ARB, or Entresto.
- Serum potassium \> 5.4 mmol/L.
- Acute coronary syndrome, stroke, transient ischemic attack, cardiovascular surgery, PCI, or carotid angioplasty within the preceding 3 months.
- Coronary or carotid artery disease likely to require surgical or percutaneous intervention within 3 months after trial entry.
- Non-cardiac condition(s) as the primary cause of dyspnea.
- Documented untreated ventricular arrhythmia with syncopal episodes within the prior 3 months.
- Symptomatic bradycardia or second or third degree heart block without a pacemaker.
- Hepatic dysfunction, as evidenced by total bilirubin \> 3 mg/dl.
- Pregnancy.
- Women who are breastfeeding
Key Trial Info
Start Date :
October 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04753112
Start Date
October 29 2020
End Date
September 20 2021
Last Update
September 28 2021
Active Locations (1)
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1
Germans Trias i Pujol University Hospital
Badalona, Barcelona, Spain, 08916