A Study of the Safety and Effectiveness of Chronic Subcutaneous CD-NP for Renal Blood Vessel Protection for Patients who have Heart Failure and an LVAD

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of a chronic subcutaneous (under the skin) injection of CD-NP, a synthetic peptide (hormone) designed here at Mayo Clinic, on the heart, the blood vessels, the kidneys, and hormone function for people who have heart failure and an LVAD. CD-NP may have protective and preferable effects on damaged heart and kidneys.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Male or non-pregnant/post-menopausal/sterile females
    • Post-menopausal is defined as the absence of menses for ≥ 1 year or serum follicle-stimulating hormone ≥ 20 IU/L
    • Sterilization in the female is defined as bilateral tubal occlusion for ≥ 6 months, bilateral oophorectomy, or complete hysterectomy
  • Age 18-90
  • In end-stage Heart Failure with LVAD support who are stable, in the healed stage, at least 3 months from the LVAD implant (Destination therapy only)
  • Willing to provide informed consent
  • All cardiac medications must be at stable doses 4 weeks prior to enrollment

Exclusion Criteria

  • Known allergy or other adverse reactions to exogenous natriuretic peptides (CD-NP or its components, nesiritide, other natriuretic peptides, or related compounds)
  • Pregnant, or breast-feeding
  • Has received nesiritide within 7 days prior to entry into the study
  • Has received any investigational drug or device within 30 days prior to entry into the study
  • Clinically unstable (e.g. mean blood pressure < 70 mmHg, ongoing requirement for vasopressors, or mechanical ventilation)
  • Recent hospitalization for decompensated HF or recent defibrillation for cardiac resuscitation within 30 days prior to randomization
  • Has guarded prognosis and unlikely to derive meaningful benefit from CD-NP
  • Presence of cardiac lesions or comorbidities that may contraindicate the use of natriuretic peptides, such as
    • Clinically significant cardiac valvular stenosis
    • Hypertrophic cardiomyopathy
    • Restrictive cardiomyopathy
    • Constrictive pericarditis
    • Primary pulmonary hypertension
    • Uncorrected congenital heart disease that contraindicates the use of vasodilators
  • Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months
  • Requirement of pressors for maintenance of blood pressure
  • Intra-aortic blood pump use
  • Severe aortic or mitral stenosis or significant LV outflow tract obstruction
  • Clinically significant renal artery stenosis > 50%
  • Baseline hemoglobin < 9.0 g/dl
  • Serum sodium < 130 mEq/L, potassium < 3.6 mEq/L, or magnesium < 1.5 mEq/L
  • Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at least 5 times the upper limit of normal or bilirubin at least 5 times the upper limit of normal
  • Creatinine clearance (CrCl) < 30 ml.min-1.1.73m-2, as calculated by Cockcroft-Gault formula(67) and adjusted for body surface area within 3 months or requirement for dialysis
  • Written history of alcohol or drug abuse within the past 6 months
  • Inability to communicate effectively with study personnel
  • BMI > 40

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Tomoko Ichiki, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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