|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 20, 2005 | ||||
| Last Updated Date | May 29, 2009 | ||||
| Start Date ICMJE | January 2006 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in central aortic stiffness, diastolic relaxation, renal blood flow,and vascular response to Ang II [ Time Frame: Measured at 4 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Peripheral and renal vascular response to Ang II infusions, renal blood flow measured by PAH clearance, conduit vessel hemodynamics, and TDI (measured at the end of each intervention feeding period, before and after acute administration of captopril) | ||||
| Change History | Complete list of historical versions of study NCT00123006 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of the DASH Diet at Reducing High Blood Pressure | ||||
| Official Title ICMJE | Cardiovascular and Renal Hemodynamics and the DASH Diet | ||||
| Brief Summary | The purpose of this study is to test the effects of the DASH diet in patients with isolated systolic hypertension. |
||||
| Detailed Description | BACKGROUND: The study expands upon the findings of the Dietary Approaches to Stop Hypertension (DASH) study, which showed that a dietary pattern emphasizing fruits, vegetables, and low fat dairy products and overall reduced in total and saturated fat significantly lowers blood pressure (BP). The DASH diet is particularly effective in African Americans and in individuals with systolic hypertension. However, it is not known if the DASH diet affects the pathophysiology of the hypertensive process. Preliminary data support the possibility that the DASH diet interrupts the renin-angiotensin system. This raises the intriguing possibility that the DASH diet will favorably impact on cardiovascular and renal hemodynamics in patients with isolated systolic hypertension. Therefore, the central hypothesis of this study is that the DASH diet affects central aortic stiffness, diastolic relaxation, and renal and vascular reactivity to angiotensin II (Ang II) by lowering tissue renin-angiotensin system activity. DESIGN NARRATIVE: A randomized, crossover design will be used to compare the DASH diet to a control diet as defined in the original DASH protocol (NEJM 1997; 336:1117). Fifty-five community-dwelling individuals age 20 and older with systolic blood pressure (SBP) 140-179 mmHg and diastolic blood pressure (DBP) less than 90 mmHg will enter a 1-week run-in period eating both the control and DASH diets for 3-4 days each. Following this, participants will begin two 4-week intervention feeding periods receiving either the DASH diet or the control diet in random order. Clinical measurements will be taken at the conclusion of each 4-week feeding period. Outcome measures: Specific measurements will include peripheral and renal vascular response to Ang II infusions, renal blood flow measured by para-aminohippurate (PAH) clearance, conduit vessel hemodynamics, and tissue Doppler imaging (TDI). At the end of each intervention feeding period, the clinical measurements will be made before and after acute administration of captopril, an angiotensin converting enzyme (ACE) inhibitor. The study will test whether the DASH diet (1) lowers central aortic stiffness as measured by vascular impedance and carotid-femoral pulse wave velocity; (2) improves diastolic relaxation as measured by early diastolic myocardial velocities across the mitral valve (Ea); (3) vasodilates renal blood flow and enhances vascular responses to Ang II; and (4) affects central aortic stiffness, diastolic relaxation, renal blood flow, and renal and vascular reactivity to Ang II by altering target tissue responsiveness to Ang II similar to ACE inhibition. |
||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 55 | ||||
| Estimated Completion Date | June 2009 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00123006 | ||||
| Responsible Party | Paul R. Conlin, MD, Brigham and Women's Hospital | ||||
| Study ID Numbers ICMJE | 229, R01 HL77234 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | February 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||