Mechanisms of Refractory Hypertension (Carvedilol)
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| ClinicalTrials.gov Identifier: NCT02357004 |
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Recruitment Status :
Withdrawn
(Change in priority of interventional protocols)
First Posted : February 6, 2015
Last Update Posted : June 12, 2020
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Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
David Calhoun, University of Alabama at Birmingham
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Brief Summary:
The purpose of this protocol is test whether patients with hypertension refractory to antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system) activity.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertensive | Drug: Carvedilol Drug: Chlorthalidone | Not Applicable |
Refractory hypertension refers to high blood pressure that is failing conventional antihypertensive therapies. In a retrospective assessment of such patients in our clinic we observed that resting clinic heart rates were higher in patients with refractory hypertension compared to patients with controlled hypertension. This observation has led to the hypothesis that refractory hypertension is caused by excessive sympathetic output. This protocol is designed to test this hypothesis by comparing the BP response to carvedilol verses chlorthalidone in patients with refractory hypertension. If their extreme treatment resistance is neurogenic is etiology, a significantly larger BP response to carvedilol should occur compared to chlorthalidone.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Study Start Date : | February 2015 |
| Actual Primary Completion Date : | January 31, 2020 |
| Estimated Study Completion Date : | January 31, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
| Arm | Intervention/treatment |
|---|---|
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Experimental: Carvedilol
Carvedilol CR 40 mg daily in addition to their normal BP medications. Subjects will be seen in follow-up at 2-week intervals for the duration of the 8-week intervention period. If the clinic BP remains elevated (>140/90 mmHg) at any of the follow-up visits, the study medication will be titrated up to carvedilol CR 80 mg daily (subjects will take 2 of the study pills).
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Drug: Carvedilol
CR 40 mg daily in addition to normal BP medications |
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Experimental: Chlorthalidone
Chlorthalidone 12.5 mg daily in addition to their normal BP medications. Subjects will be seen in follow-up at 2-week intervals for the duration of the 8-week intervention period. If the clinic BP remains elevated (>140/90 mmHg) at any of the follow-up visits, the study medication will be titrated up to chlorthalidone 25 mg daily (subjects will take 2 of the study pills).
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Drug: Chlorthalidone
12.5 mg daily in addition to normal BP medications |
Primary Outcome Measures :
- % of subjects who achieve BP control (<140/90 mm Hg) [ Time Frame: 8 weeks after baseline ]BP will be measured 8 weeks after starting carvedilol and after starting chlorthaidone. The percent of subjects with BP of <140/90 mm HG in each group will be reported.
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| Ages Eligible for Study: | 19 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Uncontrolled clinic BP (>140/90 mmHg)
- Receiving 5 or more antihypertensive agents including an ACE inhibitor or ARB, calcium channel blocker, and chlorthalidone 25 mg
Exclusion Criteria:
- Current use of an alpha or beta or combined alpha-beta antagonist
- Known allergy to alpha-beta antagonists
- CKD (eGFR <40 ml/min/m2)
- MI, stroke or episode of CHF exacerbation within 3 months
- Bradycardia <50 bpm; history of 2nd or 3rd degree heart block unless treated by a pacemaker
- Pregnant or breast-feeding women
- Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357004
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
| Principal Investigator: | David A. Calhoun, MD | Cardiology Department - University of Alabama at Birmingham |
| Responsible Party: | David Calhoun, Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT02357004 |
| Other Study ID Numbers: |
A000502641 |
| First Posted: | February 6, 2015 Key Record Dates |
| Last Update Posted: | June 12, 2020 |
| Last Verified: | June 2020 |
Additional relevant MeSH terms:
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Carvedilol Chlorthalidone Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Antioxidants |
Protective Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors |