drugset / Trial / NCT00223717

Treatment of Supine Hypertension in Autonomic Failure

NCT00223717 ↗

Phase 1 Completed 152 enrolled Vanderbilt University
RandomizedCrossoverSingle-blindTreatment

Summary

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure \[SBP\] \> 150 mmHg) or diastolic (diastolic blood pressure \[DBP\] \> 90 mmHg) hypertension (average blood pressure \[BP\]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P \< 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.

Timeline

Start
2001-01
Primary completion
2017-01
Completion
2017-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 150 mg —
Subject Aliskiren Small molecule 300 mg —
Subject Aspirin Small molecule 25 mg —
Subject Bosentan Other / unclassified 62.5 mg —
Subject Bosentan Other / unclassified 125 mg —
Subject Captopril Small molecule 25 mg —
Subject Captopril Small molecule 50 mg —
Subject Carbidopa Unknown 25 mg —
Subject Carbidopa Unknown 200 mg —
Subject Clonidine Other / unclassified 0.1 mg —
Subject Clonidine Other / unclassified 0.2 mg —
Subject Desmopressin Peptide 0.2 mg —
Subject Desmopressin Peptide 0.6 mg —
Subject Diltiazem Small molecule 30 mg —
Subject Diltiazem Small molecule 60 mg —
Subject Dipyridamole Other / unclassified 200 mg —
Subject Eplerenone Unknown 50 mg —
Subject Eplerenone Unknown 100 mg —
Subject Guanfacine Small molecule 1 mg —
Subject Guanfacine Small molecule 3 mg —
Subject Hydralazine Small molecule 10 mg —
Subject Hydralazine Small molecule 50 mg —
Subject Hydrochlorothiazide Unknown 12.5 mg —
Subject Hydrochlorothiazide Unknown 100 mg —
Subject Losartan Other / unclassified 25 mg —
Subject Losartan Other / unclassified 100 mg —
Subject Metoprolol Other / unclassified 25 mg —
Subject Metoprolol Other / unclassified 100 mg —
Subject Nebivolol Other / unclassified 2.5 mg —
Subject Nebivolol Other / unclassified 40 mg —
Subject Nifedipine Other / unclassified 10 mg Oral
Subject Nifedipine Other / unclassified 30 mg Oral
Subject Nitroglycerin Unknown 0.05 mg —
Subject Nitroglycerin Unknown 0.2 mg —
Subject Prazosin Unknown 0.5 mg —
Subject Prazosin Unknown 1 mg —
Subject Sildenafil Unknown 25 mg —
Subject Sildenafil Unknown 100 mg —
Subject Tamsulosin Other / unclassified 0.4 mg —
Subject Tamsulosin Other / unclassified 0.8 mg —

Indications