Treatment of Coronary Heart Disease With Amiloride (No)

This study has been completed.
Sponsor:
Collaborators:
Clinical Research Unit at the Docent Institute of Urology
Northern Metropolitan Hospital
Venezuelan Foundation of Heart Failure
Information provided by (Responsible Party):
Antonio Delgado Leon, MD, University of Carabobo
ClinicalTrials.gov Identifier:
NCT01231165
First received: October 29, 2010
Last updated: June 8, 2012
Last verified: April 2012
  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. The purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic changes of myocardial ischemia and electrical regeneration of the heart in subjects with coronary artery diseases.


Condition Intervention Phase
Coronary Heart Disease
Drug: Amiloride
Drug: Nitrates, clopidogrel, aspirin, statins
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Randomized Single-blind Trial of Amiloride in Coronary Heart 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, and every 6-months therafter ] [ Designated as safety issue: Yes ]
    Evaluation of Angina Class according Canadian Cardiology Society (CCS)

  • Regression of ST-T and T-waves alterations of Myocardial Ischemia [ Time Frame: Baseline and every 6-months thereafter ] [ Designated as safety issue: Yes ]
    Evaluation according Minnesota Code

  • RBC K Content [ Time Frame: Baseline and very 6-Months thereafter ] [ 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: 70
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amiloride,nitrates,clopidogrel,aspirin,statins
Comparative Efficacious Research
Drug: Amiloride
5mg/daily for 12th months
Other Names:
  • Nitrates (40mg/daily) for 12 months
  • Clopidogrel(75mg/daily)for 12 months
  • Aspirin (80mg/daily) for 12 months
  • Statins (20mg/daily) for 12 months
Active Comparator: Nitrates, clopidogrel, aspirin, statins
Comparative Efficacious Research
Drug: Nitrates, clopidogrel, aspirin, statins
Comparative Efficacious Research
Other Names:
  • Nitrates (40mg/daily) for 12 months
  • Clopidogrel(75mg/daily)for 12 months
  • Aspirin (80mg/daily) for 12 months
  • Statins (20mg/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231165

Locations
Venezuela
Hypertension Research Unit
Valencia, Carabobo, Venezuela, 2001
Sponsors and Collaborators
University of Carabobo
Clinical Research Unit at the Docent Institute of Urology
Northern Metropolitan Hospital
Venezuelan Foundation of Heart Failure
Investigators
Study Chair: Antonio J Delgado-Leon, MD University of Carabobo
Principal Investigator: Antonio R Delgado-Almeida, MD, FAHA, FACC, APS Clinical Research Unit at Docent Institute of Urology
Study Director: Carlos L Delgado-Leon, MD Venezuelan Foundation of Heart Failure
  More Information

Publications:
ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction. J Am Coll Cardiol, 2007; 50:1-157
Heart Disease and Stroke Statistics—2007 Update. A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee J Am Coll Cardiol, 2007; 50:1-157.
Delgado-Almeida A, Delgado MC. Hereditability Defect in Red-Cell K in Hypertension. FASEB J. 2008; 22:968.8 (abstract). FASEB Experimental Biology 2008. April 5-9, San Diego, California
Delgado-Almeida A, Delgado-Leon C, Delgado-Leon AJ. Amiloride and red blood cell potassium transport in coronary artery disease: Reversion of the clinical and ECG alterations (abstract). 2007 Scientific Meeting of the Inter-American Society of Hypertension and the Consortium for Southeastern Hypertension Control. Miami 6-10, 2007.

Responsible Party: Antonio Delgado Leon, MD, Prof. of Medicine, MD, University of Carabobo
ClinicalTrials.gov Identifier: NCT01231165     History of Changes
Other Study ID Numbers: UIC-5 2008
Study First Received: October 29, 2010
Last Updated: June 8, 2012
Health Authority: Venezuela: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Arteriosclerosis
Aspirin
Clopidogrel
Amiloride
Hydroxymethylglutaryl-CoA Reductase Inhibitors
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

ClinicalTrials.gov processed this record on April 17, 2014