Novel Treatment for Coronary Artery Disease

NCT01228214 | Unknown Phase 2

• 1 other identifier: UIC-3 2007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Regression of Angina Without Recurrence

  Evaluation of Angina Class according the Canadian Society of Cardiology (CCS)

  Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period

• Regression of ST-T and T-waves Alterations of Myocardial Ischemia

  Evaluation according the Minnesota Code

  Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period

• RBC Potassium Content

  Obtained by a novel accurate method developed in our laboratory (Nutr Metab Cardiovasc Dis. 2002 Jun;12(3):112-116

  Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period

Study Arms (2)

Amiloride,nitrates,clopidogrel,aspirin

EXPERIMENTAL

Comparative Efficacious Research

Drug: amiloride

Placebo,nitrates,clopidogrel,aspirin

PLACEBO COMPARATOR

Comparative Efficacious Research

Drug: Placebo

Interventions

Placebo DRUG

Placebo 5mg/daily for 12 months

Also known as: nitrates (40mg/daily for 12 months), clopidogrel(75mg/daily for 12 months), aspirin (80mg/daily for 12 months)

Placebo,nitrates,clopidogrel,aspirin

amiloride DRUG

5mg/daily for 12 months

Also known as: nitrates (40mg/daily for 12 months), clopidogrel(75mg/daily for 12 months), aspirin (80mg/daily for 12 months)

Amiloride,nitrates,clopidogrel,aspirin

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Carabobo: lead
• Clinical Research Unit at the Instituto Docente de Urologia: collaborator
• Northern Metropolitan Hospital: collaborator
• Venezuelan Foundation of Heart Failure: collaborator

Study Sites (1)

Hypertension Research Unit

Valencia, Carabobo, 2001, Venezuela

Location

Related Publications (9)

• Delgado-Almeida A. Assessing cell K physiology in hypertensive patients. A new clinical and methodologic approach. Am J Hypertens. 2006 Apr;19(4):432-6. doi: 10.1016/j.amjhyper.2005.09.013.

  PMID: 16580582 BACKGROUND

• Delgado MC, Delgado-Almeida A. Red blood cell K+ could be a marker of K+ changes in other cells involved in blood pressure regulation. J Hum Hypertens. 2003 May;17(5):313-8. doi: 10.1038/sj.jhh.1001527.

  PMID: 12756403 BACKGROUND

• Delgado-Almeida A. Unexpected therapeutic response to spironolactone: a prospective debate on aldosterone and potassium ion in hypertension. Hypertension. 2007 Nov;50(5):e164-5; author reply e166. doi: 10.1161/HYPERTENSIONAHA.107.099408. Epub 2007 Sep 10. No abstract available.

  PMID: 17846345 BACKGROUND

• Delgado-Almeida A. Reinterpreting sodium-potassium data in salt-sensitivity hypertension: a prospective debate. Hypertension. 2005 Feb;45(2):e4; author reply e4. doi: 10.1161/01.HYP.0000154194.49725.b7. No abstract available.

  PMID: 15630043 BACKGROUND

• Delgado-Almeida A. Critical value of the electrocardiogram in LVH: from predictive index to therapeutic reassessment. Hypertension. 2005 Feb;45(2):e6; author reply e6. doi: 10.1161/01.HYP.0000151782.93734.de. No abstract available.

  PMID: 15583072 BACKGROUND

• Delgado MC, Delgado-Almeida A. Red blood cell potassium and blood pressure in adolescents: a mixture analysis. Nutr Metab Cardiovasc Dis. 2002 Jun;12(3):112-6.

  PMID: 12325467 BACKGROUND

• Delgado MC, Delgado-Almeida A. Abnormal Potassium. In: Mohler III ER, Townsend RR (eds). Advanced Therapy in Hypertension and Vascular Disease. BC Decker Inc. Publisher, Ontario, Canada. 2006:291-296.

  BACKGROUND

• Weder AB, Delgado MC, Zhu X, Gleiberman L, Kan D, Chakravarti A. Erythrocyte sodium-lithium countertransport and blood pressure: a genome-wide linkage study. Hypertension. 2003 Mar;41(3 Pt 2):842-6. doi: 10.1161/01.HYP.0000048703.16933.6D. Epub 2002 Dec 23.

  PMID: 12624006 BACKGROUND

• Delgado MC. Potassium in hypertension. Curr Hypertens Rep. 2004 Feb;6(1):31-5. doi: 10.1007/s11906-004-0008-6.

  PMID: 14972087 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nitrates; Clopidogrel; Aspirin; Amiloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrazines

Study Officials

• Antonio J Delgado-Leon, MD

  University of Carabobo

  STUDY CHAIR

• Carlos L Delgado-Leon, MD

  Venezuelan Foundation of Heart Failure

  STUDY DIRECTOR

• Antonio R Delgado-Almeida, MD, FAHA, FACC, APS

  Clinical Research Unit at Docent Institute of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Medicine, MD

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

VE (1)