Condition category
Circulatory System
Date applied
27/03/2015
Date assigned
23/04/2015
Last edited
23/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to determine whether the drug niacin can help patients with high blood pressure in their lung arteries, also called pulmonary hypertension. This is a study specifically for volunteers who do NOT have high blood pressure in the lung’s arteries. This study is important because the medications that are used to treat pulmonary arterial hypertension are very limited. Any new medications that might work to lower pulmonary arterial blood pressure would be very helpful for these patients.

Who can participate?
Patients aged over 18 with a tricuspid regurgitation jet velocity over 2.7 m/s on an inpatient echocardiogram during their current hospital stay.

What does the study involve?
First, you will get an echocardiogram, which is a non-invasive test that uses ultrasound waves to evaluate a picture of the heart. You will then be randomly allocated to take one of three different pills: niacin 100 mg pill, niacin 500 mg pill, or a sugar pill (a placebo). Neither you nor the investigator will know what group you in. One hour after taking your pill, you will get a second ultrasound of your heart.

What are the possible benefits and risks of participating?
We do not expect for you to have any direct medical benefits from participating in this study, but we hope that the information we gain will help patients with pulmonary arterial hypertension. You will be compensated with a $20 gift card for your participation. This study will not interfere with the evaluation and treatment of the condition that brought you to the hospital. It will not add any cost to your stay and will not delay your discharge. Risks and side effects related to the study include flushing of your skin after taking niacin. There may also be side effects that we cannot predict. Other drugs will be given to make side effects that occur less serious and less uncomfortable.

Where is the study run from?
MedStar Georgetown University Hospital (USA).

When is the study starting and how long is it expected to run for?
March 2013 to April 2014.

Who is funding the study?
Folger Grant for Cardiovascular Prevention.

Who is the main contact?
Martin McNamara

Trial website

Contact information

Type

Public

Primary contact

Mr Martin McNamara

ORCID ID

http://orcid.org/0000-0002-4849-3313

Contact details

17612 Charity Lane
Germantown
20874
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IIS12067

Study information

Scientific title

A pilot randomized double-blinded single-dose provocation study on the effect of niacin on pulmonary arterial pressure

Acronym

Study hypothesis

We hypothesized that immediate-release niacin would reduce right ventricular systolic pressure in patients with pulmonary hypertension via the release of vasodilating prostaglandins in a randomized, double-blinded, single-dose provocation study.

Ethics approval

Institutional Review Board (IRB) of Georgetown University Hospital, 10/05/2011, study number 2012-067

Study design

Randomized double-blinded single-dose provocation study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pulmonary hypertension

Intervention

Subjects were randomized in a 1:2:2 ratio to receive a single dose of either placebo, niacin 100 mg or niacin 500 mg, respectively. TR jet velocities were measured immediately before, and one-hour post dose, corresponding to peak niacin absorption and prostaglandin release.

Intervention type

Drug

Phase

Not Applicable

Drug names

Niacin

Primary outcome measures

Change in mean tricuspid regurgitation jet velocity measured in meters/second one hour after study drug administration.

Secondary outcome measures

Change in maximum tricuspid regurgitation jet velocity measured in meters/second one hour after study drug administration.

Overall trial start date

07/06/2012

Overall trial end date

12/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over the age of 18
2. Display a tricuspid regurgitation jet velocity over 2.7 m/s on an inpatient echocardiogram during their current hospital stay

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Inability to provide written informed consent
2. Known pulmonary vascular disease
3. Known intolerance to niacin or current treatment with niacin
4. Current treatment with a non-steroidal anti-inflammatory drug (NSAID)
5. Known liver disease (AST/ALT > 3x the upper limit of normal)
6. Patients currently on ventilator support or using a bi-level positive airway pressure (BiPAP) device

Recruitment start date

25/03/2013

Recruitment end date

14/04/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

MedStar Georgetown University Hospital
-
United States of America

Sponsor information

Organisation

Georgetown University Institutional Review Board

Sponsor details

37th and O street
Washington
D.C.
20057
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Folger Grant for Cardiovascular Prevention

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We hope to publish our results as soon as possible.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26590128

Publication citations

Additional files

Editorial Notes