Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III

In brief

This study tests the hypothesis that endogenous bradykinin contributes to effects of a combined angiotensin receptor blocker/neprilysin inhibitor (LCZ696 or Entresto)

Key facts

Study ID

NCT03005184

Run by

Vanderbilt University Medical Center

People needed

0

Starts

2017-09-01

Expected to finish

2020-01-01

Last updated by the study team

2018-01-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stable patients with a reduced EF
• EF less than or equal to 40% (confirmed by echocardiogram within the last six months), and
• history of symptoms of New York Heart Association class I, II or III HF
• stable clinical symptoms including no hospitalizations for the last six months
• treatment with a stable dose of an ACEi or ARB and with a beta blocker (unless contraindicated or not tolerated) for at least four weeks
• treatment with a stable dose of an MR antagonist for at least four weeks unless not possible due to renal function or serum potassium.
• For female subjects, the following conditions must be met:
• postmenopausal status for at least one year, or
• status post-surgical sterilization

You may not qualify if…

• History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEi, ARBs, or NEPi, as well as known or suspected contraindications to the study drugs
• History of angioedema
• History of pancreatitis or known pancreatic lesions
• History of decompensated HF within the last six months (exacerbation of chronic HF manifested by signs and symptoms that required intravenous therapy or hospitalization)
• History of heart transplant or on a transplant list or with left ventricular assistance device
• Symptomatic hypotension and/or a SBP<100 mmHg at screening or <90 mmHg during the study
• Serum potassium >5.2 mmol/L at screening or >5.4 mmol/L during the study
• Acute coronary syndrome, cardiac, carotid, or other major cardiovascular surgery, percutaneous coronary intervention, or carotid angioplasty within six months prior to screening
• Coronary or carotid artery disease likely to require surgical or percutaneous intervention within six months of screening
• History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack within six months
• History of ventricular arrhythmia with syncopal episodes
• Symptomatic bradycardia or second- or third-degree atrioventricular block without a pacemaker
• Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation
• Presence of other hemodynamically significant obstructive lesions of the left ventricular outflow tract, including aortic and subaortic stenosis
• Type 1 diabetes
• Poorly controlled type 2 diabetes mellitus (T2DM), defined as a HgbA1c >9%
• Hematocrit <35%
• Impaired renal function (eGFR of <30mL/min/1.73 m2) as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dL and age in years:
• eGFR (mL/min/1.73m2)=175 • Scr-1.154 • age-0.203 • (1.212 if Black) • (0.742 if female)
• Use of hormone-replacement therapy
• Breast feeding and pregnancy
• History or presence of immunological or hematological disorders
• History of malignancy other than non-melanoma skin cancer
• Diagnosis of asthma requiring use of inhaled beta agonist more than once a week
• Clinically significant gastrointestinal impairment that could interfere with drug absorption

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.