Clinical Trial: Aliskiren and Renin Inhibition in Diastolic Heart Failure

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans

Brief Summary: This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.

Detailed Summary: Our main hypothesis is that in contrast to non Hispanic whites, the degree of RAAS system activation is more pronounced in Mexican Americans with diastolic HF and consequently their response to RAAS inhibition therapy is greater. Blocking the RAAS with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. These changes should be greater appreciated in Mexican Americans if the central pathophysiologic influence of HF in this population was RAAS maladaptation.
Sponsor: Texas Tech University Health Sciences Center

Current Primary Outcome:

  • Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers. [ Time Frame: 8 weeks ]
  • Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF. [ Time Frame: 8 weeks ]
  • Compare the clinical and biological benefit of RAAS system inhibition between aliskiren plus spironolactone and lisinopril plus spironolactone as measured by clinical indicators and serum biomarkers [ Time Frame: 8 weeks ]
  • Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites. [ Time Frame: 8 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Texas Tech University Health Sciences Center

Dates:
Date Received: October 15, 2008
Date Started: September 2008
Date Completion: August 2009
Last Updated: May 11, 2015
Last Verified: March 2011