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Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support

NCT03091998 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-07-28

No results posted yet for this study

Summary

The worldwide use of left ventricular assist devices (LVAD), which is mechanical device to improve hemodynamic function, has improved the outcomes of severe heart failure (HF) patients leading to the continued annual increase in the number of LVAD implantations. However LVAD support still results in major complications such as renal failure or gastrointestinal bleeding. The investigators hypothesize that such major complications may be due to endothelial dysfunction induced by the lack of pulsatility, which may be improved by an innovative designer natriuretic peptide, CD-NP. They have demonstrated its favorable actions in animal models as well as humans, and tested its safety in LVAD patients. They hypothesize that CD-NP will have renal and endothelial protective actions through its receptor GC-A and GC-B. Thus, the investigators will test their hypothesis with a highly translational approach to examine CD-NP's role in endothelial and renal protection.

The aim is to determine safety and tolerability together with cGMP activating, neurohumoral modulating and renovascular protective properties of chronic subcutaneous delivery of CD-NP compared to placebo in stable LVAD patients for 3 days.

Conditions

  • Heart Failure
  • Left Ventricular Assist Device
  • Natriuretic Peptide

Interventions

DRUG

CD-NP

Participants will receive a subcutaneous injection of CD-NP (5 mcg / kg) daily for 3 days

OTHER

Placebo

Participants will receive an \~ 1mL subcutaneous injection of normal saline, in lieu of Study Drug, for 3 days

Sponsors & Collaborators

Principal Investigators

  • Tomoko Ichiki, M.D.Ph.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2019-05-01
Completion
2020-05-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091998 on ClinicalTrials.gov