Aliskiren and Renin Inhibition in Diastolic Heart Failure

Last updated: May 11, 2015
Sponsor: Texas Tech University Health Sciences Center
Overall Status: Trial Not Available

Phase

N/A

Condition

Hyponatremia

Congestive Heart Failure

Heart Failure

Treatment

N/A

Clinical Study ID

NCT00773084
ARID-HF
  • Ages 21-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram withinthe 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 visitssince January 2008

Exclusion

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 Start date:
September 01, 2008
Estimated Completion Date:
August 31, 2009

Study 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.

Connect with a study center

  • Texas Tech University Health Sciences Center

    Lubbock, Texas 79430
    United States

    Site Not Available

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