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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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Diastolic Heart Failure
Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Nationality
Hispanic versus Non-Hispanic (white) Americans
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
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773084

Locations
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Selim Krim, MD, Texas Tech University Health Sciences Center--Dept. of Internal Medicine
ClinicalTrials.gov Identifier: NCT00773084     History of Changes
Other Study ID Numbers: ARID-HF
Study First Received: October 15, 2008
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Diastolic Heart Failure
Hispanic Americans
Aliskiren
Spironolactone
Lisinopril
Diastolic Heart Failure in Hispanic Americans

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Cardiovascular Diseases
Heart Diseases
Lisinopril
Spironolactone
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014