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

March 8, 2021 updated by: Horng Chen, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo infused for up to 72 hours IV
Drug: CD-NP
Randomized 1:1:1
Other Names:
  • Cenderitide
Active Comparator: CD-NP 5 ng/kg/min
CD-NP 5 ng/kg/min infused for up to 72 hours IV
Drug: CD-NP
Randomized 1:1:1
Other Names:
  • Cenderitide
Placebo Comparator: CD-NP 10 ng/kg/min
CD-NP 10 ng/kg/min infused for up to 72 hours IV
Drug: CD-NP
Randomized 1:1:1
Other Names:
  • Cenderitide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with symptomatic hypotension
Time Frame: baseline to 30 days
baseline to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Horng Chen, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

February 22, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-006317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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