Novel Treatment for Coronary Artery Disease
This study is ongoing, but not recruiting participants.
Sponsor:
University of Carabobo
Collaborators:
Clinical Research Unit at the Instituto Docente de Urologia
Northern Metropolitan Hospital
Venezuelan Foundation of Heart Failure
Information provided by (Responsible Party):
Antonio Delgado Leon, MD, University of Carabobo
ClinicalTrials.gov Identifier:
NCT01228214
First received: October 25, 2010
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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 epidemiological studies, the treatment of these patients remain complex, and and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United States and Canada documented that drug treatment, coronary interventions or both were not effective solution in coronary artery diseases.
A novel approach has recently been developed, based on the critical role of the potassium (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions.
This apparently simple mechanisms occurs in human blood in all individuals but could be altered in subjects with acquired or hereditable defect in red-blood-cell K content, as in hypertensives or CAD patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Placebo Drug: amiloride |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Double-Blind Placebo-Controlled Study of Pyrazinoylguanidine Hydrochloride (Amiloride) in Subjects With Coronary Artery Disease |
Resource links provided by NLM:
Further study details as provided by University of Carabobo:
Primary Outcome Measures:
- Regression of Angina Without Recurrence [ Time Frame: Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period ] [ Designated as safety issue: Yes ]Evaluation of Angina Class according the Canadian Society of Cardiology (CCS)
- Regression of ST-T and T-waves Alterations of Myocardial Ischemia [ Time Frame: Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period ] [ Designated as safety issue: Yes ]Evaluation according the Minnesota Code
- RBC Potassium Content [ Time Frame: Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period ] [ Designated as safety issue: No ]Obtained by a novel accurate method developed in our laboratory (Nutr Metab Cardiovasc Dis. 2002 Jun;12(3):112-116
| Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Amiloride,nitrates,clopidogrel,aspirin
Comparative Efficacious Research
|
Drug: amiloride
5mg/daily for 12 months
Other Names:
|
|
Placebo Comparator: Placebo,nitrates,clopidogrel,aspirin
Comparative Efficacious Research
|
Drug: Placebo
Placebo 5mg/daily for 12 months
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228214
Locations
| Venezuela | |
| Hypertension Research Unit | |
| Valencia, Carabobo, Venezuela, 2001 | |
Sponsors and Collaborators
University of Carabobo
Clinical Research Unit at the Instituto Docente de Urologia
Northern Metropolitan Hospital
Venezuelan Foundation of Heart Failure
Investigators
| Study Chair: | Antonio J Delgado-Leon, MD | University of Carabobo |
| Study Director: | Carlos L Delgado-Leon, MD | Venezuelan Foundation of Heart Failure |
| Principal Investigator: | Antonio R Delgado-Almeida, MD, FAHA, FACC, APS | Clinical Research Unit at Docent Institute of Urology |
More Information
Publications:
| Responsible Party: | Antonio Delgado Leon, MD, Prof. of Medicine, MD, University of Carabobo |
| ClinicalTrials.gov Identifier: | NCT01228214 History of Changes |
| Other Study ID Numbers: | UIC-3 2007 |
| Study First Received: | October 25, 2010 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Venezuela: Clinical Research Unit at the Instituto Docente de Urologia" |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Clopidogrel Amiloride Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on May 19, 2013