Masked HypertensionPhase 3NCT04121299
Mechanism of Masked Hypertension - Intervention
A Phase 3 study testing Carvedilol and Amlodipine in people with Masked Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Masked Hypertension
- What is being tested?
- Carvedilol and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study participants with masked hypertension i.e. controlled clinic blood pressure (BP) and uncontrolled out-of-clinic awake ambulatory BP will be enrolled.
- Inclusion criteria.
- 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
- Exclusion criteria.
- 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
- History of stroke within the past 6 months
- History of unstable angina within the past 6 months
- History of myocardial infarction within the past 6 months
- Allergy or intolerance to β-blockers
- Allergy or intolerance to calcium channel blockers
Trial locations and contacts
1 site in 1 country.
United States1 site
Hypertension Research Clinic at UAB
Birmingham, Alabama, 35294
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- Conditions
- Masked Hypertension
- Being tested
- Carvedilol, Amlodipine
- Keywords
- Masked Hypertension, Sympathetic Activity, Sympatholytic Therapy
- Medical subject headings
- Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Carvedilol 40mg Extended Release Once Daily
AmlodipineDrug
Amlodipine 10mg Once Daily
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol 40mg Extended Release Once Daily | Experimental | participants will be randomized to carvedilol 40 mg extended release once daily for the 1st or 2nd 4 week treatment period Receives: Drug: Carvedilol |
| Amlodipine 10mg Once Daily | Active comparator | participants will be randomized to amlodipine 10 mg once daily for the 1st or 2nd 4 week treatment period Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (4)
Out of clinic blood pressure variability
Change in out-of-clinic sympathetic activity by BP variability in mmHg with carvedilol compared to amlodipine.
Measured: 4 weeks
Out of clinic heart rate variability
Change in out-of-clinic sympathetic activity by HR variability in beats/minute with carvedilol compared to amlodipine.
Measured: 4 weeks
Out of clinic 24-hour urinary catecholamines
Change in out-of-clinic sympathetic activity by 24-hour urinary catecholamines levels with carvedilol compared to amlodipine.
Measured: 4 weeks
Out of clinic 24-hour urinary metanephrines
Change in out-of-clinic sympathetic activity by 24-hour urinary metanephrines levels with carvedilol compared to amlodipine.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study startJul 2021 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masked HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Siddiqui, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121299
- Sponsor's protocol ID
- IRB-300004152
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2019
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Masked Hypertension - Intervention
- ClinicalTrials.gov ID
- NCT04121299
- Acronym / sponsor ID
- IRB-300004152
- Conditions
- Masked Hypertension
- Keywords
- Masked Hypertension, Sympathetic Activity, Sympatholytic Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol 40mg Extended Release Once Daily | Experimental | Drug: Carvedilolparticipants 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 comparator | Drug: Amlodipineparticipants will be randomized to amlodipine 10 mg once daily for the 1st or 2nd 4 week treatment period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolCarvedilol 40mg Extended Release Once Daily | Drug | Carvedilol 40mg Extended Release Once Daily |
| AmlodipineAmlodipine 10mg Once Daily | Drug | Amlodipine 10mg Once Daily |
Primary outcome
Out of clinic 24 hour ambulatory blood pressure
Time frame: 4 weeks
Difference in percent change in out-of-clinic mean 24-hr ambulatory BP in mmHg with carvedilol compared to amlodipine.
Out of clinic awake blood pressure
Time frame: 4 weeks
Difference in percent change in out-of-clinic mean awake ambulatory BP in mmHg with carvedilol compared to amlodipine.
Out of clinic asleep blood pressure
Time frame: 4 weeks
Difference in percent change in out-of-clinic mean asleep ambulatory BP in mmHg with carvedilol compared to amlodipine.
4 secondary outcomes
Out of clinic blood pressure variability
Time frame: 4 weeks
Out of clinic heart rate variability
Time frame: 4 weeks
Out of clinic 24-hour urinary catecholamines
Time frame: 4 weeks
Out of clinic 24-hour urinary metanephrines
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carvedilol and Amlodipine in people with Masked Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Out of clinic 24 hour ambulatory blood pressure (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.