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

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 12-006317
    NCT ID: NCT02071602
    Sponsor Protocol Number: 12-006317

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Schirger, M.D.

Closed for enrollment

Contact information:

Sherry Benike R.N.

(507)266-3629

benike.sherry@mayo.edu

.
CLS-20154115

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