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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26590128