Angiotensin-II Blockade in Mitral Regurgitation
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 11, 2001 | ||||
| Last Updated Date | December 21, 2005 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00014846 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Angiotensin-II Blockade in Mitral Regurgitation | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral regurgitation. |
||||
| Detailed Description | BACKGROUND: Mitral regurgitation (MR) is frequent and its prevalence is increasing with aging of the population. Organic MR, due to primary valvular lesions has severe consequences determined by its degree, with left ventricular (LV) remodeling and dysfunction, left atrial (LA) enlargement, leading to poor clinical outcome. Surgery can eliminate MR, but carries notable risks and is not applicable to all patients. Therefore, chronically decreasing MR, protecting LV and LA with vasoactive treatment are major goals of medical therapy. However, effects of chronic oral vasoactive treatment of MR are controversial and uncertain and recent practice guidelines underscored these gaps in knowledge and did not recommend vasoactive treatment of MR. Hence, a trial of treatment of organic MR is needed. DESIGN NARRATIVE: A randomized clinical trial, placebo controlled, double-blind, without crossover, of one year oral treatment with potent tissue angiotensin blockade (with one arm using Candesartan [an angiotensin-II receptor antagonist] and one arm using Ramipril [a tissue angiotensin converting enzyme inhibitor] ) titrated to the maximally tolerated dose. The trial was preceded by an acute study to determine tolerance. End-points were measured by Doppler-Echocardiography for quantitation of MR (regurgitant volume) using a combination of three simultaneous methods (quantitative Doppler, two-dimensional echocardiography, proximal flow convergence) and combination of echocardiography and electron beam computed tomography for left ventricular and left atrial volume measurement. This single center study sought to enroll a total of 135 patients. The analysis was based on intention to treat and compared changes in regurgitant volume, left ventricular end-diastolic volume index and left atrial volume measured after one year of treatment with active drugs or placebo. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Masking: Double-Blind |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | March 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
||||
| Gender | Both | ||||
| Ages | 21 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00014846 | ||||
| Other Study ID Numbers ICMJE | 966 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | December 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||