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Aliskiren and Renin Inhibition in Diastolic Heart Failure (ARID-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773084
Recruitment Status : Withdrawn (Difficulty in recruiting patients and then the PI left the institution)
First Posted : October 16, 2008
Last Update Posted : May 12, 2015
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans
Study Start Date : September 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Drug
Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
Subjects will be in the study for a total of 8 weeks. Subjects with stable diastolic HF on current ACEI therapy will be randomized into two treatment groups. The study group will receive Aliskiren plus spironolactone and the control group will receive Lisinopril plus spironolactone. These 2 groups will be further divided according to ethnicity: Mexican Americans and non-Hispanic whites. Sixty patients will be recruited, 30 per treatment group. Subjects will have a 2 week wash-out period. At the end of this period, blood will be collected and subjects will be asked to take the assigned medication once daily for 6 weeks. Subjects will be asked to return every 2 weeks at which time blood pressure, serum potassium and creatinine levels will be assessed. Their medications will be titrated depending on clinical tolerance and symptom control. At the end of 6 weeks of treatment blood markers will be drawn and differences will be analyzed.
Other Names:
  • Tekturna
  • Lisinopril
  • Spironolactone

Primary Outcome Measures :
  1. Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers. [ Time Frame: 8 weeks ]
  2. Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF. [ Time Frame: 8 weeks ]
  3. 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 [ Time Frame: 8 weeks ]
  4. Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00773084

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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
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Responsible Party: Selim Krim, MD, Texas Tech University Health Sciences Center--Dept. of Internal Medicine Identifier: NCT00773084    
Other Study ID Numbers: ARID-HF
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: March 2011
Keywords provided by Texas Tech University Health Sciences Center:
Diastolic Heart Failure
Hispanic Americans
Diastolic Heart Failure in Hispanic Americans
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents