The purpose of this study is to look at kidney function and hormonal function in patients
with a history of heart failure and kidney dysfunction, and to see how the use of a new drug,
ANX-042, affects those functions.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
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Full eligibility criteria for NCT03019653
Ages eligible for Study
18 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
Left ventricular ejection fraction of equal or less than 40% assessed by echocardiography, nuclear scan, MRI or left ventriculogram within the past 48 months. If assessment is greater than 12 months old, hand-held echocardiogram (ECHO) determination will be performed at consent visit once enrolled.
Stable New York Heart Association (NYHA) class II and III symptoms as defined by: no change in NYHA symptoms over the past 3 months, on stable doses of furosemide, angiotensin-converting enzyme (ACE) inhibitor or angiotensin II type 1 (AT1) blocker, beta blocker, or aldosterone antagonist over the last 4 weeks and no episode of decompensated Congestive Heart Failure (CHF) over the past 6 months.
Calculated creatinine clearance of equal or less than 70 ml/min and greater than 20 ml/min, using the Modification of Diet in Renal Disease (MDRD) formula assessed within the past 48 months and a confirmatory calculated creatinine clearance equal or less than 70 ml/min and greater than 20 ml/min at the time of enrollment.
Digoxin, antiarrhythmic medications and other vasodilators will be allowed; however, all medications must be at stable doses 4 weeks prior to enrollment. Subjects taking non-steroidal anti-inflammatory drugs (NSAIDs), except aspirin, will not be able to increase their medication dose for the duration of the study.
Prior diagnosis of intrinsic renal diseases, such as glomerular nephritis or polycystic kidney disease, including renal artery stenosis of > 50% (unless revascularized)
Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
Hospitalization for decompensated CHF during the past 6 months
Myocardial infarction within 6 months of screening
Unstable angina within 6 months of screening, or any evidence of acute myocardial ischemia
Significant valvular stenosis (greater than moderate in severity) , hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
Severe congenital heart diseases
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Second or third degree heart block without a permanent cardiac pacemaker
Stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion
Alanine transaminase (ALT) >2 times the upper limit of normal
Serum sodium of < 125 milliequivalent/dL (mEq/dL) or > 160 mEq/dL
Serum potassium of < 3.0 mEq/dL or > 5.7 mEq/dL
Hemoglobin < 8.5 gm/dl
Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data
Have received an investigational drug within 1 month prior to dosing
Patients with an allergy to iodine
Female subject who is pregnant or breastfeeding
In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons
Documented systolic blood pressure less than 90 mmHg at consent visit
All locations for NCT03019653
United States (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
View full eligibility
Tris trial is registered with FDA with number: NCT03019653. The sponsor of the trial is Mayo Clinic and it is looking for 60 volunteers for the current phase.
Official trial title: A Phase Ib, Double-Blind, Placebo-Controlled, Single-site Trial to Determine the Safety and Efficacy of a Novel Renal-Specific Peptide, ANX-042, in Enhancing GFR Without Significant Hypotension in Human Cardiorenal Syndrome (CRS): ANX-042 Aim #1
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