An interventional study of Carvedilol and Chlorthalidone in Hypertensive, sponsored by University of Alabama at Birmingham. Withdrawn. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-12.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
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.
University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
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).
Drug: Carvedilol
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).
Drug: Chlorthalidone
CR 40 mg daily in addition to normal BP medications
12.5 mg daily in addition to normal BP medications
% of subjects who achieve BP control (<140/90 mm Hg)
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.
Time frame: 8 weeks after baseline
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham