Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04121299 |
Other study ID # |
IRB-300004152 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
July 2021 |
Est. completion date |
June 2026 |
Study information
Verified date |
October 2021 |
Source |
University of Alabama at Birmingham |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To test the hypothesis that sympatholytic antihypertensive antihypertensive therapy
(αβ-blocker - carvedilol) will reduce out-of-clinic ambulatory BP to a greater extent by
blocking sympathetic activity than non-sympatholytic antihypertensive medication
(dihydropyridine calcium channel blocker - amlodipine) in individuals with masked
hypertension.
Description:
A. Participants. Study participants with masked hypertension (MH) with controlled clinic BP
(< 130/80 mmHg) and uncontrolled out-of-clinic awake ambulatory BP (ABP ≥ 130/80 mmHg)
untreated with antihypertensive medications will be recruited.
B. Study design. This is a double-blinded, randomized, 2-period, 2-treatment crossover
clinical trial comparing sympatholytic antihypertensive agent (αβ-blocker - carvedilol 40mg
extended release once daily) with non-sympatholytic control agent (dihydropyridine calcium
channel blocker - amlodipine 10mg once daily) in individuals with MH. All study participants
will undergo out-of-clinic 24hr ABP with actigraphy monitoring for 24-hr, awake and asleep
ABP; sympathetic activity assessment by BP and HR variability, 24-hour urinary catecholamines
and metanephrines at baseline and after intervention. In order to avoid selection bias,
patients will be randomized to their initial therapy. Patients and study personnel will be
blinded to the treatment group in order to minimize information bias. An investigator without
direct study involvement will be assigned the task of ensuring correct dispensing of the
study medication, which will be prepared as matching capsules by the UAB Pharmacy -
Investigational Drug Service. After 4 weeks of initial treatment, both treatment groups will
undergo a 1-month washout where no study medication is given in order to prevent a carryover
effect. The study medication will be taken in the morning between 6 and 9 am except for study
visit days. A crossover design is chosen to minimize differences between study groups, as
participants will act as their own controls. Electrolytes, kidney function and ECG will be
monitored at each visit. Medication adherence will be determined at visit 2 (week 4) and
visit 4 (week 12) by measuring 24-hr urinary specimens for medications and their metabolites
by LC-MS/MS and by pill count and medication log.
C. Outcomes. The primary outcome is the difference in percent change in out-of-clinic mean
24-hr ABP, awake ABP and asleep ABP with carvedilol compared to amlodipine. Secondary
outcomes include change in out-of-clinic sympathetic activity by BP and HR variability; and
24-hour urinary catecholamines and metanephrines.
D. Preliminary / anticipated results. We anticipate a greater reduction in out-of-clinic
24-hr, awake and asleep ABP due to blocking of sympathetic activity with carvedilol when
compared to amlodipine use in individuals with MH. A statistically significant effect
estimate will support our hypothesis that higher sympathetic activity contributes to MH,
which can be managed by use of sympatholytic agents like carvedilol.