A pilot study on the effect of niacin on pulmonary arterial pressure
| ISRCTN | ISRCTN12353191 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12353191 |
| Secondary identifying numbers | IIS12067 |
- Submission date
- 27/03/2015
- Registration date
- 23/04/2015
- Last edited
- 17/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
17612 Charity Lane
Germantown
20874
United States of America
 ORCID ID |
0000-0002-4849-3313 |
|---|
Study information
| Study design | Randomized double-blinded single-dose provocation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A pilot randomized double-blinded single-dose provocation study on the effect of niacin on pulmonary arterial pressure |
| Study objectives | 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(s) | Institutional Review Board (IRB) of Georgetown University Hospital, 10/05/2011, study number 2012-067 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 07/06/2012 |
| Completion date | 12/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 49 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/03/2013 |
| Date of final enrolment | 14/04/2014 |
Locations
Countries of recruitment
- United States of America
Study participating centre
United States of America
Sponsor information
University/education
37th and O street
Washington, D.C.
20057
United States of America
"ROR" |
https://ror.org/05vzafd60 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We hope to publish our results as soon as possible. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/11/2015 | Yes | No |
Editorial Notes
17/05/2023: Total final enrolment added.
