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

Phase 1

Completed

• Conditions: Left Ventricular Insufficiency
• Interventions: Drug: Placebo; Drug: CD-NP

• Registration Number: NCT01750905
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

This study is a double blind, placebo-controlled phase I trial of the safety and neurohumoral activity of CD-NP, in the treatment of heart failure with LVAD support. Subjects more than 3 months after LVAD implantation will be screened at outpatient clinic visit appointments lists and interested qualified subjects will be either confronted at a visit or sent a letter in the mail to be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established at day 1 and subjects will be given subcutaneous injection of placebo or CD-NP and stay overnight on two different visits in the Clinical Research Unit (CRU). Participant's will receive both placebo and the CD-NP during the study, one per visit. A final follow-up visit for clinical assessment will be conducted over the phone at the end of the study.

Potential subjects who present to Mayo Clinic, Rochester, Minnesota for follow up clinical visit after LVAD implantation will be identified by the study coordinator. A $300 remuneration per subject will be involved to compensate for the inconvenience to the subject. A $500 reimbursement of gas mileage will be provided for those who travel.

Study Timeline

• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Study Start: 2013-04
• Primary Completion: 2016-05
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo: Vehicle (D5W) SQ
CD-NP	CD-NP	CD-NP 5 ug/kg subcutaneous injection (SQ)

Primary Outcome Measures

Name	Time	Method
Number of subjects with Hypotension	approx day 9

Secondary Outcome Measures

Name	Time	Method
Mean plasma Cyclic guanosine monophosphate (cGMP) level	Approx day 9
Mean aldosterone level	approx 9 days

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States