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

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Amlodipine; Calcium Channel Blockers; Hydrochlorothiazide; Losartan

Criteria

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.