Aliskiren and Renin Inhibition in Diastolic Heart Failure

NCT00773084 | Withdrawn

• 1 other identifier: ARID-HF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure

Keywords

Diastolic Heart Failure; Hispanic Americans; Aliskiren; Spironolactone; Lisinopril; Diastolic Heart Failure in Hispanic Americans

Outcome Measures

Primary Outcomes (4)

• Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers.

  8 weeks

• Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.

  8 weeks

• 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

  8 weeks

• Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.

  8 weeks

Study Arms (1)

Drug

ACTIVE COMPARATOR

Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Interventions

Aliskiren plus spironolactone vs. Lisinopril plus spironolactone DRUG

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.

Also known as: Tekturna, Lisinopril, Spironolactone

Drug

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

aliskiren; Spironolactone; Lisinopril

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 12, 2015

Record last verified: 2011-03

Locations

US (1)