N-of-1 Trials for Blood Pressure Medications in Adults

Completed · Early Phase 1

Conditions studied: Hypertension, High Blood Pressure

In brief

Many patients want to know which blood pressure medication is the best for them. In this study, we will test the feasibility of a new approach to determining the best blood pressure medication for individual patients by performing an N-of-1 trial in which patients will have the opportunity to test a series of 3 blood pressure medications at escalating doses while carefully measuring their blood pressure and side-effects. At the end of each of these N-of-1 trials, we will ask patients to complete a questionnaire in which they rate their level of satisfaction with this approach to learning about which is the best blood pressure medication for them.

Key facts

Study ID

NCT02744456

Run by

Columbia University

People needed

10

Starts

2014-08-01

Expected to finish

2017-12-31

Last updated by the study team

2019-03-26

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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