Heart Failure With Reduced Ejection Fraction Clinical Trial
— PARADOROfficial title:
Prospective Comparison of an ARNI With an ACE Inhibitor on enDOthelial Function by Brachial Artery Reactivity (PARADOR)
Verified date | October 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PARADOR is multisite, randomized, double-blind, phase IV clinical trial to compare the effect of sacubitril/valsartan (Entrestoâ„¢) to enalapril (Vasotec®) on blood vessel function in subjects with heart failure with reduced ejection fraction (HFREF).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Willing to provide written informed consent - Willing to comply with all study procedures and be available for the duration of the study - Male or female, at least 18 years of age - Documented diagnosis of heart failure - Documented history of left ventricular ejection fraction < 40% in the 6 months of randomization - NYHA functional class II or III - Current treatment with an ACEI at a stable dose of at least enalapril 5 mg twice daily or equivalent for at least 30 days - Stable heart failure medications (ACEi, +/-beta blocker, +/-mineralocorticoid receptor antagonist) for the past 30 days (with the exception of diuretics) Females of childbearing potential must have a negative urine pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has not undergone a hysterectomy or bilateral oophorectomy; or - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: - Documented or self-reported history of hereditary or idiopathic angioedema - History of acute coronary syndrome, cardiac bypass procedure, stroke, or transient ischemic attack within three months of randomization - Placement of a biventricular pacemaker device within 6 months of randomization - History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes - Current use of sacubitril/valsartan - Previous intolerance to ACE inhibitors - Baseline Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 per the Modification of Diet in Renal Disease (MDRD) formula - History of bilateral renal artery stenosis - History of hepatic dysfunction - Baseline serum potassium greater than 5.2 mmol/L - Baseline systolic blood pressure less than 110 mmHg or greater than 180 mmHg - Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization - Women who are pregnant or breast-feeding - Not suitable for study participation due to other reasons at the discretion of the investigator |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Novartis Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flow Mediated Vasodilation | To test the hypothesis that sacubitril/valsartan will improve endothelial function compared to enalapril, evidenced by increased flow mediated vasodilation (FMD) measured by brachial artery reactivity test (BART) | At study treatment completion (10 weeks) | |
Secondary | B-type natriuretic peptide | To test the hypothesis that sacubitril/valsartan will decrease N-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations as compared to enalapril | At study treatment completion (10 weeks) |
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