Status:
COMPLETED
Replication of the PARADIGM-HF Heart Failure Trial in Healthcare Claims Data.
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of cl...
Detailed Description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to re...
Eligibility Criteria
Inclusion
- Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- All patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of sacubitril/valsartan or a ACEi (cohort entry).
- Eligible cohort entry dates:
- Market availability of sacubitril/valsartan in the U.S. started on July 7, 2015.
- For Marketscan: July 7, 2015 - December 31, 2018 (end of data availability)
- For Optum: July 7, 2015 - March 31, 2020 (end of data availability)
- For Medicare: July 7, 2015 - December 31, 2017 (end of data availability)
- Age 18 years or older
- NYHA functional class II-IV
- LVEF ≤ 35%
- AND the following:
- Hospitalization for heart failure within the last 12 months
- Treatment with a stable dose of an ACE inhibitor or an ARB equivalent to enalapril 10 mg/day for at least 4 weeks before the screening visit; and treatment with a stable dose of a beta-blocker for at least 4 weeks prior to the screening visit, unless contraindicted or not tolerated
- Treatment with a stable dose of an ACE inhibitor or an ARB equivalent to enalapril 10 mg/day for at least 4 weeks before the screening visit
- AND the following:
- Treatment with a stable dose of a beta-blocker for at least 4 weeks prior to the screening visit, unless contraindicated or not tolerated
Exclusion
- Known history of angioedema
- Requirement for treatment with both ACEIs and ARBs
- Current acute decompensated heart failure (exacerbation of chronic heart failure manifested by signs and symptoms that may require intravenous therapy)
- Symptomatic hypotension and/or a systolic blood pressure \<100 mmHg at Visit 1 (screening) or \<95 mmHg at Visit 3 or at Visit 5 (randomization)
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 at Visit 1 (screening), Visit 3 (end of enalapril run-in), or Visit 5 (end of LCZ696 run-in and randomization) or \>35% decline in eGFR between Visit 1 and Visit 3 or between Visit 1 and Visit 5
- Serum potassium \>5.2 mmol/L at Visit 1 (screening) or \>5.4 mmol/L at Visit 3 or Visit 5 (randomization)
- Acute coronary syndrome, stroke, transient ischaemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within the 3 months prior to Visit 1.
- Implantation of a cardiac resynchronization therapy (CRT) device within 3 months prior Visit 1 or intent to implant a CRT
- History of heart transplant or on a transplant list or with LV assistance device
- History of severe pulmonary disease
- Diagnosis of peripartum- or chemotherapy-induced cardiomyopathy within the 12 months prior to Visit 1
- Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to Visit 1
- Documented ventricular arrhythmia within the 3 months prior to Visit 1
- AND the following:
- Syncopal episodes within the 3 months prior to Visit 1
- AND the following:
- Untreated ventricular arrhythmia within the 3 months prior to visit 1
- OR the following:
- Untreated ventricular arrhythmia within the 3 months prior to visit 1
- Symptomatic bradycardia or second- or third-degree atrioventricular block without a pacemaker
- Presence of haemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation
- Presence of other haemodynamically significant obstructive lesions of the LV outflow tract, including aortic and subaortic stenosis
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including, but not limited to, any of the following:
- History of active inflammatory bowel disease during the 12 months before Visit 1
- OR the following:
- Active duodenal or gastric ulcers during the 3 months prior to Visit 1
- OR the following:
- Evidence of hepatic disease as determined by any one of the following: aspartate aminotransferase or alanine aminotransferase values exceeding 2× upper limit of normal at Visit 1, history of hepatic encephalopathy, history of oesophageal varices, or history of porto-caval shunt
- OR the following:
- Current treatment with cholestyramine or colestipol resins
- Presence of any other disease with a life expectancy of 5 years
- Any Ivabradine use -- Approved in April 2015 (same year as Entresto)
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
6066 Patients enrolled
Trial Details
Trial ID
NCT04736433
Start Date
September 22 2020
End Date
February 18 2021
Last Update
August 1 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120