- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02744456
N-of-1 Trials for Blood Pressure Medications in Adults
A Pilot Study of N-of-1 Trials of Blood Pressure Medications in Adults With Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 21 to 80 years.
- History of physician-diagnosed hypertension.
- Currently not treated with antihypertensive medication but with consensus (from patient and his/her physician; patients with elevated ABPM who are not on treatment will be considered eligible irrespective of office BP if the patient's physician is in agreement with a trial of BP medications) that antihypertensive medication should be initiated; or being treated with one antihypertensive medication.
- No history of suspected or confirmed white coat hypertension (elevated clinic BP but non-elevated out-of-clinic BP either by home BP monitoring or ABPM).
- Easy access to and regular use of e-mail as they will need to be able to respond to Qualtrics surveys at regular intervals during the self-monitoring period.
- Established relationship with an accessible primary care provider.
- Primary care provider gives permission to participation in an N-of-1 trial.
Exclusion Criteria:
- Severe hypertension (office BP = 180/110 mm Hg).
- History of myocardial infarction, heart failure, atrial fibrillation, or chronic kidney disease as these patients have guideline recommended indications for specific classes of BP medications.
- Electrolyte abnormality; if no electrolyte panel is available in the prior 6 months, then one will be ordered for purposes of the study.
- Known drug allergy or intolerance to angiotensin receptor blocker, calcium channel blocker, or thiazide diuretic.
- Prescribed BP medication for indication other than hypertension (e.g., migraine headache prophylaxis, enlarged prostate).
- Primary care provider permission not obtained.
- Non-English speaking.
- No regular (daily) access and use of e-mail as participants will need to be able to respond to emailed links to surveys for completion of self-monitoring symptoms.
- Unable to provide informed consent or adhere to study protocol due to cognitive impairment, mental illness, or other reasons.
- Unable to monitor BP at home using an automatic BP machine due to physical or mental impairments.
- Unable to track side effects of medications due to physical or mental impairments including literacy problems.
- Arm circumference <9 inches or >17 inches as these sizes do not accommodate the range of BP cuff sizes that are available for the automatic BP machine.
- Unavailable for follow-up during the study period due to severe medical illness or other reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: N-of-1 trial
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.
Other Names:
A calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension.
Other Names:
A diuretic medication often used to treat high blood pressure and swelling due to fluid build up.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants satisfied with blood pressure regimen
Time Frame: 5 months (or 1 month after completing N-of-1 trial)
|
Treatment Satisfaction Questionnaire for Medication
|
5 months (or 1 month after completing N-of-1 trial)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to antihypertensive medication
Time Frame: 5 months (or 1 month after completing N-of-1 trial)
|
Voils Nonadherence Measure
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5 months (or 1 month after completing N-of-1 trial)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ian Kronish, MD, MPH, Columbia Univeristy Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Amlodipine
- Losartan
- Hydrochlorothiazide
Other Study ID Numbers
- AAAN9419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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