NCT02071602

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Interventions

Type	Name	Description
DRUG	CD-NP	Randomized 1:1:1

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-05-01
• Completion: 2018-11-01
• First posted: 2014-02-26
• Last updated: 2021-03-10

Locations

1 site across 1 country: United States