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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
John A. Schirger, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02071602
First received: November 15, 2013
Last updated: February 22, 2014
Last verified: February 2014
  Purpose

The primary endpoint is to assess the safety and tolerability of CD-NP with the incidence of symptomatic hypotension being one of the key safety variables.


Condition Intervention Phase
Anterior ST-Elevation Myocardial Infarction
Drug: CD-NP
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of subjects with symptomatic hypotension [ Time Frame: baseline to 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of LV function improvement between placebo vs. CD-NP groups [ Time Frame: baseline to 30 days ] [ Designated as safety issue: No ]
  • Exploratory analyses of Major Adverse Cardiovascular Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo infused for up to 72 hours IV
Drug: CD-NP
Randomized 1:1:1
Other Name: 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 Name: 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 Name: Cenderitide

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first time ST elevation anterior STEMI
  • 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 PTCA within 24 hours of onset of symptoms as documented by coronary angiography
  • No previous history of an anterior AMI or previous ECG suggesting an old anterior AMI.

Exclusion Criteria:

  • Cardiogenic shock, acute heart failure or hypotension (Systolic BP < 90 mmHg)
  • Previous MI
  • 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
  • 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
  • Serum potassium of < 3.0 mEq/dL or > 5.8 mEq/dL
  • Hemoglobin < 8.5 gm/dl
  • 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
  • Unable to undergo cardiac MRI
  • In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071602

Contacts
Contact: Lynn E Polk, RN 507-255-2527 polk.lynn@mayo.edu
Contact: Cindy M Woltman, RN 507-266-4095 woltman.cindy@mayo.edu

Locations
United States, Florida
Mayo Clinic in Florida Not yet recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John Schirger, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: John A. Schirger, Princpal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02071602     History of Changes
Other Study ID Numbers: 12-006317
Study First Received: November 15, 2013
Last Updated: February 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Heart attack
Myocardial Infarction
STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014