Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02357017
Status:
WITHDRAWN
Last Update Posted:
2020-06-12
First Post:
2015-01-22
Brief Title:
Mechanisms of Refractory Hypertension High and Low Salt Diet
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Mechanisms of Refractory Hypertension High and Low Salt Diet
Status:
WITHDRAWN
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in priority of interventional protocols
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to test the hypothesis that persistent fluid retention and high sympathetic output contributes to the development of refractory hypertension HTN The investigators will determine in a cross-over assessment of high and low salt diets if dietary sodium restriction reduces 24-hr ambulatory BP in patients with refractory HTN Moreover the investigators will determine if dietary sodium restriction lessens the severity of obstructive sleep apnea OSA in patients with refractory HTN
Detailed Description:
We are proposing a unique phenotype of antihypertensive treatment failure that we refer to as refractory HTN We have come to feel that while resistant RHTN represents a broad phenotype with multiple and overlapping etiologies of treatment resistance there is a unique subset of patients who never achieve BP control in spite of maximal therapy In a recently published retrospective analysis of our clinic experience we found that patients with refractory HTN comprised about 10 of patients referred to us for RHTN
A large number of intervention studies have verified the benefit of dietary salt restriction to reduce BP We made such an assessment in a prospective randomized cross-over comparison of high- and low salt diets in 12 patients with confirmed RHTN The average reduction in BP going from high to the low salt diet was 2310 mmHg in the clinic and 2010 mmHg during 24-hr ambulatory BP monitoring These dramatic results demonstrated that patients with RHTN are exquisitely salt-sensitive and highlight the degree of BP reduction that can be accomplished with meaningful salt restriction However we are proposing the novel hypothesis that refractory HTN is mechanistically unique from RHTN in that it is not secondary to recalcitrant fluid retention
Determining an association between dietary salt restriction and severity of obstructive sleep apnea OSA would potentially help us to find new therapies guided towards achieving better control of BP in patients with refractory HTN We will investigate the effect of dietary salt intake on severity of OSA vascular function in patients with refractory HTN by doing vascular studies pulse wave analysisvelocity calculating thoracic impedance
A large number of intervention studies have verified the benefit of dietary salt restriction to reduce BP We made such an assessment in a prospective randomized cross-over comparison of high- and low salt diets in 12 patients with confirmed RHTN The average reduction in BP going from high to the low salt diet was 2310 mmHg in the clinic and 2010 mmHg during 24-hr ambulatory BP monitoring These dramatic results demonstrated that patients with RHTN are exquisitely salt-sensitive and highlight the degree of BP reduction that can be accomplished with meaningful salt restriction However we are proposing the novel hypothesis that refractory HTN is mechanistically unique from RHTN in that it is not secondary to recalcitrant fluid retention
Determining an association between dietary salt restriction and severity of obstructive sleep apnea OSA would potentially help us to find new therapies guided towards achieving better control of BP in patients with refractory HTN We will investigate the effect of dietary salt intake on severity of OSA vascular function in patients with refractory HTN by doing vascular studies pulse wave analysisvelocity calculating thoracic impedance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None