Safety Study of Chimeric Natriuretic Peptide(CD-NP) in Stable LVAD Patients

NCT01750905 | Completed Phase 1

• 1 other identifier: 12-001869
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The most promising chimeric natriuretic peptide designed and studied by our group has been CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal volunteers and human heart failure patients. Since left ventricular assist device (LVAD) can not reverse remodeling of the heart whereas it can improve hemodynamics, CD-NP may be novel anti-fibrotic and anti-remodeling drug as co-therapy during LVAD support.

Conditions

Left Ventricular Insufficiency

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Hypotension

  approx day 9

Secondary Outcomes (2)

• Mean plasma Cyclic guanosine monophosphate (cGMP) level

  Approx day 9

• Mean aldosterone level

  approx 9 days

Study Arms (2)

CD-NP

ACTIVE COMPARATOR

CD-NP 5 ug/kg subcutaneous injection (SQ)

Drug: CD-NP

Placebo

PLACEBO COMPARATOR

Placebo: Vehicle (D5W) SQ

Drug: Placebo

Interventions

CD-NP DRUG

CD-NP 5 ug/kg subcutaneous injection (SQ)

CD-NP

Placebo DRUG

Vehicle (D5W) SQ

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant/post-menopausal female, ages 18-90, in end-stage Heart Failure (HF) with LVAD support who are stable in the healed stage after at least 3 months from the LVAD implant (Destination therapy only) (the post-menopausal state is defined as the absence of menses for ≥ 1 year and 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)
• Be willing to provide informed consent.

You may not qualify if:

• Known allergy or other adverse reactions to exogenous natriuretic peptides (CD-NP or its components, nesiritide, other natriuretic peptides, or related compounds).
• Women who are pregnant, or breast-feeding.
• Having received nesiritide within 7 days prior to prior to entry into the study.
• Having received any investigational drug or device within 30 days prior to entry into the study.
• Clinically unstable patients (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.
• Patients with guarded prognosis who are unlikely to derive meaningful benefit from CD-NP.
• Use of sulfonamides, non-steroidal anti-inflammatory drugs, probenecid, or other drugs that are known to alter renal function within one week of the first dose of CD-NP or placebo.
• 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, or 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
• Clinically significant renal artery stenosis
• Baseline hemoglobin \< 9.0 g/dl.
• Serum sodium \< 130 mEq/L, potassium \< 3.6 milliequivalents per Liter (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(35) and adjusted for body surface area within 3 months or at screening, or requirement for dialysis.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• John Schirger, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)