CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function (BELIEVE III)
Primary Purpose
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CD-NP
Sponsored by
About this trial
This is an interventional treatment trial for ST Elevation (STEMI) Myocardial Infarction of Anterior Wall focused on measuring Heart attack, Myocardial Infarction, STEMI
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Placebo
CD-NP 5 ng/kg/min
CD-NP 10 ng/kg/min
Arm Description
Placebo infused for up to 72 hours IV
CD-NP 5 ng/kg/min infused for up to 72 hours IV
CD-NP 10 ng/kg/min infused for up to 72 hours IV
Outcomes
Primary Outcome Measures
Number of subjects with symptomatic hypotension
Secondary Outcome Measures
Comparison of LV function improvement between placebo vs. CD-NP groups
Exploratory analyses of Major Adverse Cardiovascular Events (MACE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02071602
Brief Title
CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function
Acronym
BELIEVE III
Official Title
CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Keywords
Heart attack, Myocardial Infarction, STEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo infused for up to 72 hours IV
Arm Title
CD-NP 5 ng/kg/min
Arm Type
Active Comparator
Arm Description
CD-NP 5 ng/kg/min infused for up to 72 hours IV
Arm Title
CD-NP 10 ng/kg/min
Arm Type
Placebo Comparator
Arm Description
CD-NP 10 ng/kg/min infused for up to 72 hours IV
Intervention Type
Drug
Intervention Name(s)
CD-NP
Other Intervention Name(s)
Cenderitide
Intervention Description
Randomized 1:1:1
Primary Outcome Measure Information:
Title
Number of subjects with symptomatic hypotension
Time Frame
baseline to 30 days
Secondary Outcome Measure Information:
Title
Comparison of LV function improvement between placebo vs. CD-NP groups
Time Frame
baseline to 30 days
Title
Exploratory analyses of Major Adverse Cardiovascular Events (MACE)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horng Chen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Related Info
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CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function
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