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Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

NCT01544998 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-03-22

Study results available
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Summary

This study is being done to determine the effects of subcutaneous (under the skin) injection of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart, in combination with Tadalafil on:

* The pumping function of the heart
* Kidney function
* Hormonal function (levels of different hormones in your blood) in persons with lower pumping function of their heart.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

Nesiritide

10 ug/kg

DRUG

Tadalafil

5 mg

DRUG

Placebo

The pharmacy will create a placebo subcutaneous injection volume to match the volume of Nesiritide dose.

DRUG

Saline load

Normal saline 0.9% 0.25 ml/kg/min for 60 minutes

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Horng H Chen, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-08-31
Completion
2014-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01544998 on ClinicalTrials.gov