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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02071602

First Posted

November 15, 2013

Last Updated

March 8, 2021

Sponsor

Mayo Clinic

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

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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