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

This study has been withdrawn prior to enrollment.
(Difficulty in recruiting patients and then, the PI left the institution)
Sponsor:
Information provided by:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00773084
First received: October 15, 2008
Last updated: June 2, 2011
Last verified: March 2011

October 15, 2008
June 2, 2011
September 2008
August 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773084 on ClinicalTrials.gov Archive Site
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Aliskiren and Renin Inhibition in Diastolic Heart Failure
Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diastolic Heart Failure
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
  • No Intervention: Nationality
    Hispanic versus Non-Hispanic (white) Americans
    Intervention: Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
  • Active Comparator: Drug
    Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
    Intervention: Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00773084
ARID-HF
No
Selim Krim, MD, Texas Tech University Health Sciences Center--Dept. of Internal Medicine
Texas Tech University Health Sciences Center
Not Provided
Not Provided
Texas Tech University Health Sciences Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP