N-of-1 Trials for Blood Pressure Medications in Adults
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|ClinicalTrials.gov Identifier: NCT02744456|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension High Blood Pressure||Drug: Losartan Drug: Amlodipine Drug: Hydrochlorothiazide||Phase 2|
The goal of this research is to empower hypertensive patients to learn which blood pressure (BP) medication is best for them. Although lifestyle factors such as diet and exercise play an important role, medications may still needed to achieve BP control. Yet, there are substantial differences in the way BP medications affect patients; medications well-tolerated in some, cause severe side-effects in others. Similarly, medications that cause larger reductions in BP in some patients have smaller BP lowering effects in others. Despite this heterogeneity in treatment effects, there are no proven real-world methods to help patients identify the medication most suited to their needs.
One potential approach to individualizing BP treatment decisions is to conduct N-of-1 trials: a multiple crossover design conducted in a single patient. Despite the appeal of this approach, there are few published reports of BP medication N-of-1 trials. Therefore, the objective of this study is to determine the feasibility of conducting an N-of-1 BP medication trial in hypertensive patients. Patients who meet all the eligibility criteria will be asked to monitor their blood pressure and side-effects while taking a series of commonly prescribed blood pressure medications. If they are already taking a blood pressure medication, they will begin by tracking their blood pressure and side-effects while taking this medication for 1 week. They will then be asked to track their blood pressure and side-effects while taking a series of up to three other blood pressure medications (losartan - a renin-angiotensin system blocking agent, amlodipine - a calcium channel blocker, and hydrochlorothiazide - a thiazide diuretic). Each of these medications will be taken for 2 weeks at a time. The specific choice of medications and medication doses will be selected by the study physician. Unless patients have side-effects that lead them to discontinue a medication early, patients will be expected to take each medication at least twice in a balanced sequence (e.g., losartan - amlodipine - HCTZ - HCTZ - amlodipine - losartan). Patients will measure their blood pressure and medication side-effects during the 2nd week on each of these medications. Patients will have the option of escalating or decreasing dosages to identify the single medication/medication dose that best lowers their blood pressure with the least side-effects. Blood pressure will be measured using an Omron home blood pressure monitor. Side-effects will be tracked using a daily e-mailed survey that is completed over the Internet.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of N-of-1 Trials of Blood Pressure Medications in Adults With Hypertension|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Patients with hypertension who are taking none or one BP medication will be will be provided with prescriptions for up to 3 BP medications representative of different BP medication classes (i.e., losartan, an angiotensin system blocking agent; amlodipine, a calcium channel blocker; and hydrochlorothiazide, a thiazide diuretic). Patients will be asked to take each medication for 2 weeks at a low dose, 2 weeks at a medium dose, and then 2 weeks at a high dose; provide health information and identify which medication they prefer to remain on following the N-of-1 trial (i.e., for long-term use).
An angiotensin II receptor antagonist drug used mainly to treat high blood pressure.
A calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension.
A diuretic medication often used to treat high blood pressure and swelling due to fluid build up.
- Participants satisfied with participating in N-of-1 trial [ Time Frame: 4 months ]Question assessing helpfulness of participating in N-of-1 trial methodology with respecting to managing their hypertension
- Participants satisfied with blood pressure regimen [ Time Frame: 5 months (or 1 month after completing N-of-1 trial) ]Treatment Satisfaction Questionnaire for Medication
- Adherence to antihypertensive medication [ Time Frame: 5 months (or 1 month after completing N-of-1 trial) ]Voils Nonadherence Measure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744456
|Contact: Ian Kronish, M.D., M.P.H.||firstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Ian M Kronish, MD, MPH 212-342-1335 email@example.com|
|Contact: Alexandra Sullivan, MPH 212-305-1256 firstname.lastname@example.org|
|Principal Investigator: Ian M Kronish, MD, MPH|
|Principal Investigator:||Ian Kronish, M.D., M.P.H.||Columbia Univeristy Medical Center|