Novel Treatment for Coronary Artery Disease

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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:
  • nitrates (40mg/daily for 12 months)
  • clopidogrel(75mg/daily for 12 months)
  • aspirin (80mg/daily for 12 months)
Placebo Comparator: Placebo,nitrates,clopidogrel,aspirin
Comparative Efficacious Research
Drug: Placebo
Placebo 5mg/daily for 12 months
Other Names:
  • nitrates (40mg/daily for 12 months)
  • clopidogrel(75mg/daily for 12 months)
  • aspirin (80mg/daily for 12 months)

  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:

  1. Male or female, age 35-75 years having angina (Canada Cardiovascular Society Class II-IV)
  2. 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
  3. ST-T changes of LVH (Romhilt-Estes or Framingham Heart Study criteria, with typical LV strain pattern, or isoelectric, inverted or biphasic T waves)
  4. ST-T changes of ischemia in resting ECG (ST depression, isoelectric, biphasic, negative or inverted T-waves)
  5. Serum potassium < 5.0 mmol/L prior to randomization
  6. Negative pregnancy test in child-bearing potential women
  7. Willing to comply with scheduled visits
  8. Informed consent form signed by the subject

Exclusion Criteria:

  1. Resistance hypertension despite 3-drugs treatment
  2. Myocardial infarction in past 90 days
  3. Coronary artery bypass graft surgery in past 90 days
  4. Atrial fibrillation with a resting heart rate > 90 bpm
  5. Percutaneous coronary intervention in past 30 days
  6. Implanted Pacemaker
  7. Stroke in past 90 days
  8. Left or Right Ventricular Branch Block
  9. Aldosterone antagonist or K sparing drug in last 7 days
  10. Intolerance to amiloride
  11. Lithium use
  12. Current participation in any other therapeutic trial
  13. Any condition that may prevent the subject from adhering to the trial protocol
  14. History of hyperkalemia (K ≥5.5 mmol/L) in the past six months or K >5.0 mmol/L within 2 weeks
  15. Chronic renal dysfunction
  16. Liver disease
  17. Chronic pulmonary disease
  18. Significant uncorrected valvular heart disease
  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: 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 September 22, 2014