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

NCT02744456 | Completed Early Phase 1

• 1 other identifier: AAAN9419
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; High Blood Pressure

Keywords

Hydrochlorothiazide tablet; Norvasc; Cozaar; amlodipine besylate tablets; losartan potassium tablets; Hypertension; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Participants satisfied with participating in N-of-1 trial

  Question assessing helpfulness of participating in N-of-1 trial methodology with respecting to managing their hypertension

  4 months

Secondary Outcomes (1)

• Participants satisfied with blood pressure regimen

  5 months (or 1 month after completing N-of-1 trial)

Other Outcomes (1)

• Adherence to antihypertensive medication

  5 months (or 1 month after completing N-of-1 trial)

Study Arms (1)

N-of-1 trial

OTHER

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).

Drug: Losartan; Drug: Amlodipine; Drug: Hydrochlorothiazide

Interventions

Losartan DRUG

An angiotensin II receptor antagonist drug used mainly to treat high blood pressure.

Also known as: Losartan potassium tablets, Cozaar

N-of-1 trial

Amlodipine DRUG

A calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension.

Also known as: Amlodipine besylate tablets, Norvasc

N-of-1 trial

Hydrochlorothiazide DRUG

A diuretic medication often used to treat high blood pressure and swelling due to fluid build up.

Also known as: HCTZ, Hydrochlorothiazide tablets

N-of-1 trial

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Kronish IM, Cheung YK, Shimbo D, Julian J, Gallagher B, Parsons F, Davidson KW. Increasing the Precision of Hypertension Treatment Through Personalized Trials: a Pilot Study. J Gen Intern Med. 2019 Jun;34(6):839-845. doi: 10.1007/s11606-019-04831-z. Epub 2019 Mar 11.

  PMID: 30859504 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ian Kronish, MD, MPH

  Columbia Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 20, 2016
• Study Start: August 1, 2014
• Primary Completion: August 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

US (1)