CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function

Study Overview
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Brief Summary
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The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables.

Detailed Description
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This is a proof of concept, randomized, double-blind, placebo controlled study. The study population will include 60 patients admitted with a first time ST elevation anterior STEMI as diagnosed by the following criteria: a) Significant chest discomfort and /or shortness of breath; b) ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads; c) Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or PTCA within 24 hours of onset of symptoms as documented by coronary angiography; and d) No previous history of an anterior AMI or previous ECG suggesting an old anterior AMI. Patients will be randomized to one of two doses of CD-NP (5 ng/kg/min and 10 ng/kg/min) or placebo continuous infusion for up to 72 hours in a 1:1:1 manner. All patients will receive other standard medical therapies as determined appropriate by the physician and in accordance to the ACC/AHA guidelines

Official Title
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CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study

Conditions
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ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Intervention / Treatment
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* Drug: CD-NP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Significant chest discomfort and /or shortness of breath ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography No previously known history of AMI (prior to current cardiac event) or no previous ECG (prior to current cardiac event) suggesting an old AMI (Q wave on presenting ECG is not an exclusion).. Exclusion Criteria:(Assessed at the time of enrollment unless otherwise stated) Cardiogenic shock, acute heart failure or hypotension (Systolic BP < 90 mmHg) Previous known decreased EF < 40% Atrial Fibrillation Persistent signs and symptoms of Post MI ischemia Requirement of pressors for maintenance of blood pressure. Intra-aortic blood pump use Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension. Severe congenital heart diseases Sustained ventricular tachycardia or ventricular fibrillation Second or third degree heart block without a permanent cardiac pacemaker Stroke within 3 months or other evidence of significantly compromised CNS perfusion Total bilirubin of > 2.5 mg/dL or other liver enzymes >2.5 times the upper limit of normal if available clinically and measured within the last 7 days Patients with calculated GFR <30 ml by MDRD equation or those with acute kidney injury as defined by an increase of plasma creatinine of 0.5 mg/dL from a plasma creatinine measured within the last 7 days Serum sodium of < 125 mEq/dL or > 160 mEq/dL if available clinically and measured within the last 7 days Serum potassium of < 3.0 mEq/dL or > 5.8 mEq/dL if available clinically and measured within the last 7 days Hemoglobin < 8.5 gm/dl if available clinically and measured within the last 7 days 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 Received an investigational drug within 1 month prior to dosing 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo infused for up to 72 hours IV | Drug: CD-NP<br>* Randomized 1:1:1<br>* Other names: Cenderitide;|
| Active Comparator: CD-NP 5 ng/kg/min<br>CD-NP 5 ng/kg/min infused for up to 72 hours IV | Drug: CD-NP<br>* Randomized 1:1:1<br>* Other names: Cenderitide;|
| Placebo Comparator: CD-NP 10 ng/kg/min<br>CD-NP 10 ng/kg/min infused for up to 72 hours IV | Drug: CD-NP<br>* Randomized 1:1:1<br>* Other names: Cenderitide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with symptomatic hypotension |  | baseline to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of LV function improvement between placebo vs. CD-NP groups |  | baseline to 30 days | 
| Exploratory analyses of Major Adverse Cardiovascular Events (MACE) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart attack, Myocardial Infarction, STEMI