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NCT00223717 · ClinicalTrials.gov registry record · Phase 1
Treatment of Supine Hypertension in Autonomic Failure
A Phase 1 study of Hypertension, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT00223717: Completed Phase 1 study of Hypertension, sponsored by Vanderbilt University.
NCT00223717 is a Phase 1 study of Hypertension that has completed, run by Vanderbilt University. The registered enrollment target is 152 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223717, a Phase 1 study of Hypertension, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Sildenafil
- DRUG Clonidine
- DRUG Nitroglycerin transdermal
- DRUG Dipyridamole/ Aspirin (Aggrenox)
- DRUG Desmopressin (DDAVP)
Study Locations (1)
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2001-01 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT00223717 record still lists
NCT00223717 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 5 interventions - of which Sildenafil is the first listed.
NCT00223717 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00223717 about?
NCT00223717 is a clinical study titled "Treatment of Supine Hypertension in Autonomic Failure". 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),...
What is the current status of trial NCT00223717?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2001-01. Estimated completion is 2017-01.
What conditions does trial NCT00223717 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00223717?
The interventions under investigation include: Sildenafil (DRUG), Clonidine (DRUG), Nitroglycerin transdermal (DRUG), Dipyridamole/ Aspirin (Aggrenox) (DRUG), Desmopressin (DDAVP) (DRUG).
Who is sponsoring clinical trial NCT00223717?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00223717 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00223717's enrollment target sits among peer trials
152 245th of 470 higher than 225 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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