CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Nesiritide +3 moredrug
Likely dose
Tadalafil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01544998
NCT01544998Phase 2Completed
CompareCT.gov

To Define the Role of PDEV in Mediating the Decreased GFR and Attenuated Renal Sodium and cGMP Excretory Response to Acute Saline Volume Expansion in PSD and PDD With Renal Dysfunction.

Mayo Clinic·interventional·Posted Mar 6, 2012·Updated Mar 22, 2018

In Brief

A Phase 2 clinical trial evaluating Nesiritide, Tadalafil, and 2 other interventions for Congestive Heart Failure. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.3 years ago

Interventions

Nesiritidedrug

10 ug/kg

Tadalafildrug

5 mg

Placebodrug

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

Saline loaddrug

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