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Comparing ARNI With ACE Inhibitor on Endothelial Function (PARADOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119623
Recruitment Status : Withdrawn (Lost funding prior to study commencing)
First Posted : April 18, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Scott David Solomon, Brigham and Women's Hospital

Brief Summary:
PARADOR is multisite, randomized, double-blind, phase IV clinical trial to compare the effect of sacubitril/valsartan (Entresto™) to enalapril (Vasotec®) on blood vessel function in subjects with heart failure with reduced ejection fraction (HFREF).

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Drug: sacubitril/valsartan Drug: Enalapril Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Comparison of an ARNI With an ACE Inhibitor on enDOthelial Function by Brachial Artery Reactivity (PARADOR)
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Sacubitril/Valsartan
Sacubitril/valsartan 100mg (Dose Level 1) titrated up if tolerated to 200 mg twice daily (Dose Level 2)
Drug: sacubitril/valsartan
Sacubitril/valsartan 100mg titrated up to sacubitril/valsartan 200mg
Other Names:
  • ENTRESTO
  • LCZ696

Active Comparator: Enalapril
Enalapril 5mg (Dose Level 1) titrated up if tolerated to 10mg twice daily (Dose Level 2)
Drug: Enalapril
enalapril 5mg, titrated up to 10mg po BID
Other Name: Vasotec




Primary Outcome Measures :
  1. Flow Mediated Vasodilation [ Time Frame: At study treatment completion (10 weeks) ]
    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)


Secondary Outcome Measures :
  1. B-type natriuretic peptide [ Time Frame: At study treatment completion (10 weeks) ]
    To test the hypothesis that sacubitril/valsartan will decrease N-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations as compared to enalapril



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119623


Sponsors and Collaborators
Brigham and Women's Hospital
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Orly Vardeny, PharmD, MS University of Wisconsin, Madison
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Responsible Party: Scott David Solomon, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03119623    
Other Study ID Numbers: 2017P002389/PHS
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Scott David Solomon, Brigham and Women's Hospital:
Heart Failure
Endothelial function
Brachial Artery Reactivity Test
Sacubitril/Valsartan
Enalapril
HFREF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
Enalapril
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors