Aliskiren and Renin Inhibition in Diastolic Heart Failure

• Status: Withdrawn
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Treatments: Lisinopril; Spironolactone

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