Study Stopped
lack of funding
Mechanism of Masked Hypertension - Intervention
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
November 5, 2021
October 1, 2021
4.9 years
October 7, 2019
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Out of clinic 24 hour ambulatory blood pressure
Difference in percent change in out-of-clinic mean 24-hr ambulatory BP in mmHg with carvedilol compared to amlodipine.
4 weeks
Out of clinic awake blood pressure
Difference in percent change in out-of-clinic mean awake ambulatory BP in mmHg with carvedilol compared to amlodipine.
4 weeks
Out of clinic asleep blood pressure
Difference in percent change in out-of-clinic mean asleep ambulatory BP in mmHg with carvedilol compared to amlodipine.
4 weeks
Secondary Outcomes (4)
Out of clinic blood pressure variability
4 weeks
Out of clinic heart rate variability
4 weeks
Out of clinic 24-hour urinary catecholamines
4 weeks
Out of clinic 24-hour urinary metanephrines
4 weeks
Study Arms (2)
Carvedilol 40mg Extended Release Once Daily
EXPERIMENTALparticipants will be randomized to carvedilol 40 mg extended release once daily for the 1st or 2nd 4 week treatment period
Amlodipine 10mg Once Daily
ACTIVE COMPARATORparticipants will be randomized to amlodipine 10 mg once daily for the 1st or 2nd 4 week treatment period
Interventions
Carvedilol 40mg Extended Release Once Daily
Eligibility Criteria
You may qualify if:
- Adults (18-75 years of age)
- Controlled clinic BP (\< 130/80 mmHg) untreated with antihypertensive medications
- Uncontrolled awake ambulatory BP (≥ 130/80 mmHg) untreated with antihypertensive medications
You may not qualify if:
- Hypertensive (Clinic BP ≥ 130/80 mmHg)
- Hypotensive (Clinic BP \< 90/70 mmHg)
- Bradycardic (Heart rate \< 60 beats/minute)
- Heart block
- Use of an antihypertensive medication within the last 3 months
- Use of an steroid containing medications within the last 3 months
- Body mass index ≥ 30 Kg/m2
- Chronic kidney disease (Estimated GFR \< 60 mL/min/1.73m2)
- Primary aldosteronism
- Renal artery stenosis
- Pheochromocytoma
- Diabetes mellitus
- Pregnant women
- Breast feeding women
- Dementia and/or cognitive impairment prohibiting consent
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hypertension Research Clinic at UAB
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Postdoctoral Fellow, Vascular Biology and Hypertension Program, Division of Cardiovascular Disease
Study Record Dates
First Submitted
October 7, 2019
First Posted
October 9, 2019
Study Start
July 1, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Research data will be shared with non-participating investigators once the data are accepted for publication.
- Access Criteria
- All accepted manuscripts will be submitted electronically to PubMed Central (PMC) via the NIH Manuscript Submission (NIHMS) system according to journal policy and NIH agreements. Through the Freedom of Information Act, the data in the publications and the raw data documents will be made available upon written request.
Will adhere to the NIH Data Sharing and Implementation policy: https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm Data Sharing: Unpublished research data will be presented at scientific meetings. These regularly include American Heart Association Council on Hypertension Scientific Sessions and Southern Society of Clinical Investigators-southern regional meeting. Moreover, unpublished data, including methodologies and datasets will be uploaded to RedCap with access granted to mentor, co-mentors and members of mentoring committee. All data acquired will be shared and made publicly available through publication in the peer-reviewed literature.