Morning Versus Evening Dosing of Antihypertensive Medications: A Pilot Study to Assess Feasibility and Efficacy

NCT01965847 | Completed

• 1 other identifier: UMNDrawz1
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Ambulatory blood pressure (BP) monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Importantly, elevated nighttime BP is a modifiable risk factor; evening dosing of antihypertensive medications lower nighttime BP and reduces proteinuria. In a large, randomized controlled trial, evening dosing of antihypertensive medications reduced the hazard rate for major cardiovascular events by 67%. Findings were similar in the subgroup of participants with chronic kidney disease (CKD). However, this single-center study was designed to evaluate cardiovascular outcomes, not progression of CKD. The long-term effect of nighttime dosing of antihypertensive medications on progression of CKD is unknown. To address this important gap in knowledge, the investigators plan to conduct a pragmatic, randomized controlled trial. 3600 participants at risk for progression of CKD who are taking ≥1 antihypertensive medication once daily will be randomized to morning versus evening dosing of at least one antihypertensive medication. The purpose of the current study is to obtain pilot data demonstrating the feasibility of the trial and the efficacy of the intervention.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Adherence to timing instructions

  Participants will be called three to six weeks after their clinic visit by study personnel. Participants will be asked the following questions about the once a day antihypertensive medication involved in the study: "In the last seven days, how many times did you take \[name of antihypertensive medication\] in the morning? In the last seven days, how many times did you take \[name of antihypertensive medication\] in the evening?"

  3-6 weeks after intervention

Secondary Outcomes (1)

• General medication adherence

  3-6 weeks after intervention

Study Arms (2)

AM dosing

ACTIVE COMPARATOR

The study student pharmacist will perform medication therapy management with a focus on antihypertensive medications and specifically on the once daily antihypertensive assigned to MORNING dosing. Medication therapy management will take place in the clinic or by phone. Medication therapy management will include review of antihypertensive medications, patient empowerment and education, and provision of a personal medication record to the participant with specific instructions regarding the once daily antihypertensive medication assigned to morning versus evening. If a patient is taking more than one antihypertensive medication, only one will be used for the current study.

Behavioral: Medication therapy management

PM dosing

EXPERIMENTAL

The study student pharmacist will perform medication therapy management with a focus on antihypertensive medications and specifically on the once daily antihypertensive assigned to EVENING dosing. Medication therapy management will take place in the clinic or by phone. Medication therapy management will include review of antihypertensive medications, patient empowerment and education, and provision of a personal medication record to the participant with specific instructions regarding the once daily antihypertensive medication assigned to morning versus evening. If a patient is taking more than one antihypertensive medication, only one will be used for the current study.

Behavioral: Medication therapy management

Interventions

Medication therapy management BEHAVIORAL

AM dosing; PM dosing

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate to severe kidney disease, defined as:
• Estimated glomerular filtration rate 20-45 mls/min/1.73m2; or
• Estimated glomerular filtration rate: 45-60 mls/min/1.73m2 with proteinuria defined by either a urine albumin to creatinine ratio \>300mg/g or a urine protein to creatinine ratio \>500mg/g.
• Age 19-80 years
• Taking one or more non-diuretic antihypertensive medication once daily
• Appointment at the University of Minnesota Medical Center Renal Clinic.

You may not qualify if:

• Pregnant women
• Patients that are difficult to follow-up with: prisoners, non-English speakers
• Patients with adherence difficulty: Mentally disabled, emotionally disabled, developmentally disabled, impaired decision making capacity.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• Smith JR, Hillman L, Drawz PE. Pharmacist-based antihypertensive medication review and assignment of morning versus evening dosing of once-daily antihypertensive medications: A pilot study to assess feasibility and efficacy in chronic kidney disease patients. Clin Exp Hypertens. 2018;40(6):569-573. doi: 10.1080/10641963.2017.1411493. Epub 2017 Dec 6.

  PMID: 29211509 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 18, 2013
• Study Start: November 1, 2013
• Primary Completion: April 17, 2015
• Study Completion: April 17, 2015
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

US (1)