IRB Number:

07-004493

Trial Status:

Open for Enrollment

Phase: IV

Why is this study being done?

The purpose of this study is to compare the safety and effectiveness of sildenafil (Viagra) to a placebo (a pill containing no medication) in patients with diastolic heart failure to see if it will improve your ability to exercise and your quality of life. You will be asked to take this study medication for 6 months.

Who is Eligible to Participate in the Study?

Patients diagnosed with diastolic heart failure with current NYHA Class II-IV symptoms. They must also have had one of the following within the last 12 months:
1. Hospitalization for decompensated heart failure
2. Acute treatment of heart failure with IV diuretics or hemofiltration
3. Chronic treatment with a diuretic for control of heart failure symptoms and chronic diastolic dysfunction on echocardiography as evidenced by left atrial enlargement

Patients must also be on stable medical therapy for 30 days and meet screening criteria.

Patients must not have any condition that prevents them from exercise testing or from walking in a hallway, pericardial disease, hypertrophic cardiomyopathy or severe renal dysfunction.

Minimum Age:

18

Maximum Age:

100

What is Involved With this Study?

This study involves 7 study visits over 6 months time; consent and screening tests, baseline testing, randomization and initial dosing of drug, week 1 post-dosing visit, week 4 study visit with labs, week 12 visit with studies and dose escalation, week 13 post-dosing visit, 24 week final visit with studies. There are also phone visits after initiation and dosage changes of the drug and again at week 3, 8, 16, and 20.

Screening involves exam by physician, blood tests, limited pulmonary function testing and cardiopulmonary stress test. Baseline testing involves echocardiogram, cardiac MRI, blood tests, electrocardiogram, 6-minute walk, and a questionnaire. Labs will be drawn at week 4 follow-up visit. Week 12 visit includes exam by physician, blood draw, cardiopulmonary stress test, 6-minute walk and questionnaire. Week 24 (final visit) includes all tests listed for week 12 along with a cardiac MRI test.

How long will the Study run?

This study will last approximately 6 months.

Who can I Contact for Additional Information on this Trial?

Janet Gatzke, RN Study Coordinator 507-538-7177
Beth Kaping, RN Study Coordinator 507-255-7962
Sue Milbrandt, Study Coordinator 507-538-6105

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/01/2009