Aliskiren and Renin Inhibition in Diastolic Heart Failure
Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diastolic Heart Failure
Intervention: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Texas Tech University Health Sciences Center
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.
Clinical Details
Official title: Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers.Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF. 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 Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.
Detailed description:
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram
within the last 2 years
2. NYHA classes I-III, symptomatically stable (for >1month)
3. Age 21-70 years
4. Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white
5. Patients on ACE inhibitor therapy (lisinopril)
6. Blood pressure >100/75 mmHg
7. Adequate birth control
8. Patients seen in TTUHSC Cardiology or Internal Medicine clinic for at least two
visits since January 2008
Exclusion Criteria:
1. Acute coronary syndrome (within the last month).
2. Recent acute diastolic or systolic HF (within the last month)
3. Pancreatic disease
4. Renal artery stenosis
5. Pregnancy
6. History of angioedema
7. Severe hypotension (systolic BP<90mmHg or mean arterial pressure <65mmHg)
8. Hyperkalemia (defined by K+>5 mEq/L)
9. Chronic Kidney Disease (Stage 3 and above)
10. Systolic dysfunction (ejection fraction below 50%)
11. Ethnicity other than Mexican American or non-Hispanic white
Locations and Contacts
Texas Tech University Health Sciences Center, Lubbock, Texas 79430, United States
Additional Information
Starting date: September 2008
Last updated: May 11, 2015
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