Aliskiren and Renin Inhibition in Diastolic Heart Failure

Not Applicable

Withdrawn

• Conditions: Diastolic Heart Failure
• Interventions: Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

• Registration Number: NCT00773084
• Lead Sponsor: Texas Tech University Health Sciences Center

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 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2011-03
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	Aliskiren plus spironolactone vs. Lisinopril plus spironolactone	Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Primary Outcome Measures

Name	Time	Method
Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.	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	8 weeks
Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.	8 weeks
Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers.	8 weeks

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States