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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:October 2013
End Date:November 2018

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

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.

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

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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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