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

Primary Purpose

Diastolic Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring Diastolic Heart Failure, Hispanic Americans, Aliskiren, Spironolactone, Lisinopril, Diastolic Heart Failure in Hispanic Americans

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Drug

Arm Description

Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Outcomes

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.
Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.
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
Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2008
Last Updated
May 11, 2015
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT00773084
Brief Title
Aliskiren and Renin Inhibition in Diastolic Heart Failure
Acronym
ARID-HF
Official Title
Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruiting patients and then the PI left the institution
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
Diastolic Heart Failure, Hispanic Americans, Aliskiren, Spironolactone, Lisinopril, Diastolic Heart Failure in Hispanic Americans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug
Arm Type
Active Comparator
Arm Description
Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
Intervention Type
Drug
Intervention Name(s)
Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
Other Intervention Name(s)
Tekturna, Lisinopril, Spironolactone
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

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Aliskiren and Renin Inhibition in Diastolic Heart Failure

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