Status:

WITHDRAWN

Aliskiren and Renin Inhibition in Diastolic Heart Failure

Lead Sponsor:

Texas Tech University Health Sciences Center

Conditions:

Diastolic Heart Failure

Eligibility:

All Genders

21-70 years

Phase:

NA

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. Add...

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 i...

Eligibility Criteria

Inclusion

  • Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram within the last 2 years
  • NYHA classes I-III, symptomatically stable (for \>1month)
  • Age 21-70 years
  • Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white
  • Patients on ACE inhibitor therapy (lisinopril)
  • Blood pressure \>100/75 mmHg
  • Adequate birth control
  • Patients seen in TTUHSC Cardiology or Internal Medicine clinic for at least two visits since January 2008

Exclusion

  • Acute coronary syndrome (within the last month).
  • Recent acute diastolic or systolic HF (within the last month)
  • Pancreatic disease
  • Renal artery stenosis
  • Pregnancy
  • History of angioedema
  • Severe hypotension (systolic BP\<90mmHg or mean arterial pressure \<65mmHg)
  • Hyperkalemia (defined by K+\>5 mEq/L)
  • Chronic Kidney Disease (Stage 3 and above)
  • Systolic dysfunction (ejection fraction below 50%)
  • Ethnicity other than Mexican American or non-Hispanic white

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2009

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00773084

Start Date

September 1 2008

End Date

August 1 2009

Last Update

May 12 2015

Active Locations (1)

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1

Texas Tech University Health Sciences Center

Lubbock, Texas, United States, 79430