Clinical Trial: CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study
Brief Summary: 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 Summary:
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
Sponsor: Mayo Clinic
Current Primary Outcome: Number of subjects with symptomatic hypotension [ Time Frame: baseline to 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Comparison of LV function improvement between placebo vs. CD-NP groups [ Time Frame: baseline to 30 days ]
- Exploratory analyses of Major Adverse Cardiovascular Events (MACE) [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: November 15, 2013
Date Started: October 2013
Date Completion: December 2016
Last Updated: August 29, 2016
Last Verified: August 2016