Status:
UNKNOWN
Novel Treatment for Coronary Artery Disease
Lead Sponsor:
University of Carabobo
Collaborating Sponsors:
Clinical Research Unit at the Instituto Docente de Urologia
Northern Metropolitan Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Treatment of coronary artery disease is a major health care problem across the entire word, and the United States. Unfortunately, despite a number of medical advances, diagnostic procedure, or epidemi...
Detailed Description
Treatment of Cardiovascular Diseases (CVD) is a major health care problem across the entire word, and particularly in the United States. In fact, these life-threatening disorders are a major cause of ...
Eligibility Criteria
Inclusion
- Male or female, age 35-75 years having angina (Canada Cardiovascular Society Class II-IV)
- Essential Hypertension defined as taking at least 1 anti-hypertensive medication, or average systolic blood pressure ≥140 mm Hg, or diastolic blood pressure ≥90 mmHg
- ST-T changes of LVH (Romhilt-Estes or Framingham Heart Study criteria, with typical LV strain pattern, or isoelectric, inverted or biphasic T waves)
- ST-T changes of ischemia in resting ECG (ST depression, isoelectric, biphasic, negative or inverted T-waves)
- Serum potassium \< 5.0 mmol/L prior to randomization
- Negative pregnancy test in child-bearing potential women
- Willing to comply with scheduled visits
- Informed consent form signed by the subject
Exclusion
- Resistance hypertension despite 3-drugs treatment
- Myocardial infarction in past 90 days
- Coronary artery bypass graft surgery in past 90 days
- Atrial fibrillation with a resting heart rate \> 90 bpm
- Percutaneous coronary intervention in past 30 days
- Implanted Pacemaker
- Stroke in past 90 days
- Left or Right Ventricular Branch Block
- Aldosterone antagonist or K sparing drug in last 7 days
- Intolerance to amiloride
- Lithium use
- Current participation in any other therapeutic trial
- Any condition that may prevent the subject from adhering to the trial protocol
- History of hyperkalemia (K ≥5.5 mmol/L) in the past six months or K \>5.0 mmol/L within 2 weeks
- Chronic renal dysfunction
- Liver disease
- Chronic pulmonary disease
- Significant uncorrected valvular heart disease
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01228214
Start Date
March 1 2011
End Date
September 1 2013
Last Update
March 19 2013
Active Locations (1)
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1
Hypertension Research Unit
Valencia, Carabobo, Venezuela, 2001