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Novel Treatment for Coronary Artery Disease

NCT01228214 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-03-19

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Placebo

Placebo 5mg/daily for 12 months

DRUG

amiloride

5mg/daily for 12 months

Sponsors & Collaborators

  • Clinical Research Unit at the Instituto Docente de Urologia

    collaborator UNKNOWN

  • Northern Metropolitan Hospital

    collaborator UNKNOWN

  • Venezuelan Foundation of Heart Failure

    collaborator OTHER

  • University of Carabobo

    lead OTHER

Principal Investigators

  • Antonio J Delgado-Leon, MD · University of Carabobo

  • Carlos L Delgado-Leon, MD · Venezuelan Foundation of Heart Failure

  • Antonio R Delgado-Almeida, MD, FAHA, FACC, APS · Clinical Research Unit at Docent Institute of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-04-30
Completion
2013-09-30

Countries

  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228214 on ClinicalTrials.gov