Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-02-28
Study Completion Date
2011-02-28
Brief Summary
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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.
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.
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Detailed Description
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The Problem: Treatment of Cardiovascular Diseases (CVD) is a major health care problem across the entire word, and particularly in the United States, Japan and European Countries (1). In fact, these life-threatening disorders are a major cause of emergency medical care and hospitalization in the United States, and according the National Center for Health Statistics (NCHS) there were approximately 1,565,000 hospitalizations for primary or secondary diagnosis of an acute coronary syndrome (ACS), 669,000 for unstable angina (UA) and 896,000 for myocardial infarction (MI). In the 2003, NCHS reported 4,497,000 visits to emergency departments for primary diagnosis of CVD, wherein the average age of a person having a first heart attack is calculated at 65.8 years for men and 70.4 years for women (2)
Although the treatment of angina, chest pain secondary to coronary heart disease (stable chronic angina) and one of the most common and early symptom of Coronary Heart Disease (CHD) can be tracked as far as 1880's, it still represents a medically unresolved problem. Indeed, treatment of angina in particular, as well as associated condition as ACS, UA, and MI, involves a large number of life-style recommendations, dietetic advice, drugs, coronary artery intervention, or coronary bypass surgery aimed to improve symptoms, quality of life of patients, and even primary or secondary prevention of the stable chronic angina. Unfortunately, despite a century of medical advances and epidemiological studies, the current approach to CVD and coronary heart disease remain complex, and at times frustrating.
Among the proposals to treat stable chronic angina new aspects have been considered, including the single "polypill" agent (aspirin + statin + 3 blood pressure lowering agents in half dose, and folic acid), Simvastatin and intravascular ultrasound study, or intra-coronary angiogenesis therapy (3-5). However, most of them are unpractical, whereas it is difficult to determine whether these changes will translate to meaningful reductions in clinical events, or whether results in highly selected patient populations can be matched to the real-world of prevention and treatment of coronary artery syndromes.
Further, a recent large clinical trial, COURAGE study (6), conducted in 50 hospital centers in the United States and Canada showed that optimal drug treatment and percutaneous coronary interventions for stable coronary heart disease, was not more effective than optimal medical therapy alone for preventing cardiovascular events, hospitalization or death, suggesting that drugs, surgical procedures or both were not a statistically effective solution for stable chronic angina. By inference, a therapeutic approach for mot severe coronary syndromes as UA, post- myocardial infarction angina, or aggravated angina episodes, seems to be a more distant goal.
Physiological Basis for Innovation: For more than a century, the extremely rapid coupled tissue O2/CO2 gas exchange and ion H/K transport by Hemoglobin (Hb) in red blood cell (RBC) has been well known for scientific community, the so-called Bohr/Haldane Effect (7). Since then, it has been noted and confirmed that RBC have a critical role to maintain normal vascular function, blood flow and tissue oxygenation and acid-base regulation. These functional roles of RBC include a nitric oxide (NO) transport, NO synthetasa, and regulation of platelet aggregation, vascular rheology, and endothelial function (8). Indeed, recent studies have demonstrated that erythrocyte serves as a regulator of vascular tone and tissue perfusion, whereas the hemoglobin and RBC itself may be sensors for the oxygen tissue requirement (9).
In this context, the evidence that erythrocytes are the major intravascular storage of nitrites (10), and that nitroglycerin effects on erythrocyte rheology and oxygen unloading in myocardial ischemia are mediated by S-Nitrosohemoglobin (11) implies that RBC K exchange should be preserved in subjects with CHD, especially if a hereditable defect in RBC K transport exists (12). Unfortunately, and despite such multiple integrated functions to maintain tissue oxygenation in health and diseases states, the role of RBC has never been considered in the therapeutic approach of stable chronic angina (13). However, our recent observation that reversal of an abnormal low RBC K content in hypertensive patients receiving low doses of pyrazinoylguanidine hydrochloride (amiloride HCl, 5 mg), and calcium gluconolactate was associated with a better control of BP, and regression of the ST-T alterations related to LVH or coronary heart disease (14), strongly support a novel mechanistic approaches to improve blood flow and myocardium oxygen transport in stable chronic angina.
Informed consent will be obtained in each patient, and the Review board committee of the Docent Institute of Urology, University of Carabobo Medical School, Valencia, will approve the trial. This trial is a continuation of the Protocol ID UIC-3 2007 (Novel Treatment for Coronary Artery Disease, NCT 01228214) and will be also registered in the ClinicalTrials.gov
METHODS
(I) Clinical Methods
At the inclusion period and in each clinical visit all subjects had measurements of BP, HR, body weight/height and measurement of body resistance and reactance for Body Composition Analysis of Total Body water and extra-cellular spaces, Fat-Free-Mass, Fat Mass. Number of anginal episodes, and functional anginal class (CCS) will be recorded in each case.
(II) Laboratory Methods
All patients will have routine measurement of Ion Transport Studies, which includes a 12-hour night (7 pm- 7 am) urine collection, followed by fasting state for measurement of plasma (Na, K, Cl, Mg++, Ionized calcium), RBC (Na, K, H2O content), and urine (Na, K, Cl, Mg++, calcium) electrolytes, along with plasma and urine osmolality, at entry, 4-week, and at 3, 8 and 12-months period.
(III) Cardiovascular Studies
All subjects All subjects had resting 12-lead ECG at entry, and non-invasive hemodynamic and PWA (DynaPulse200M, San Diego, CA) for Aortic Stiffness (Augmentation index, and Travel-Time-Reflected-Wave), Systemic and Brachial Artery Resistance and Compliances, obtained at entry and during clinical visits, including possible emergency attention. EchoC, or Doppler studies will be evaluated at baseline, 6-month, and 12-month periods.
Although the treatment of angina, chest pain secondary to coronary heart disease (stable chronic angina) and one of the most common and early symptom of Coronary Heart Disease (CHD) can be tracked as far as 1880's, it still represents a medically unresolved problem. Indeed, treatment of angina in particular, as well as associated condition as ACS, UA, and MI, involves a large number of life-style recommendations, dietetic advice, drugs, coronary artery intervention, or coronary bypass surgery aimed to improve symptoms, quality of life of patients, and even primary or secondary prevention of the stable chronic angina. Unfortunately, despite a century of medical advances and epidemiological studies, the current approach to CVD and coronary heart disease remain complex, and at times frustrating.
Among the proposals to treat stable chronic angina new aspects have been considered, including the single "polypill" agent (aspirin + statin + 3 blood pressure lowering agents in half dose, and folic acid), Simvastatin and intravascular ultrasound study, or intra-coronary angiogenesis therapy (3-5). However, most of them are unpractical, whereas it is difficult to determine whether these changes will translate to meaningful reductions in clinical events, or whether results in highly selected patient populations can be matched to the real-world of prevention and treatment of coronary artery syndromes.
Further, a recent large clinical trial, COURAGE study (6), conducted in 50 hospital centers in the United States and Canada showed that optimal drug treatment and percutaneous coronary interventions for stable coronary heart disease, was not more effective than optimal medical therapy alone for preventing cardiovascular events, hospitalization or death, suggesting that drugs, surgical procedures or both were not a statistically effective solution for stable chronic angina. By inference, a therapeutic approach for mot severe coronary syndromes as UA, post- myocardial infarction angina, or aggravated angina episodes, seems to be a more distant goal.
Physiological Basis for Innovation: For more than a century, the extremely rapid coupled tissue O2/CO2 gas exchange and ion H/K transport by Hemoglobin (Hb) in red blood cell (RBC) has been well known for scientific community, the so-called Bohr/Haldane Effect (7). Since then, it has been noted and confirmed that RBC have a critical role to maintain normal vascular function, blood flow and tissue oxygenation and acid-base regulation. These functional roles of RBC include a nitric oxide (NO) transport, NO synthetasa, and regulation of platelet aggregation, vascular rheology, and endothelial function (8). Indeed, recent studies have demonstrated that erythrocyte serves as a regulator of vascular tone and tissue perfusion, whereas the hemoglobin and RBC itself may be sensors for the oxygen tissue requirement (9).
In this context, the evidence that erythrocytes are the major intravascular storage of nitrites (10), and that nitroglycerin effects on erythrocyte rheology and oxygen unloading in myocardial ischemia are mediated by S-Nitrosohemoglobin (11) implies that RBC K exchange should be preserved in subjects with CHD, especially if a hereditable defect in RBC K transport exists (12). Unfortunately, and despite such multiple integrated functions to maintain tissue oxygenation in health and diseases states, the role of RBC has never been considered in the therapeutic approach of stable chronic angina (13). However, our recent observation that reversal of an abnormal low RBC K content in hypertensive patients receiving low doses of pyrazinoylguanidine hydrochloride (amiloride HCl, 5 mg), and calcium gluconolactate was associated with a better control of BP, and regression of the ST-T alterations related to LVH or coronary heart disease (14), strongly support a novel mechanistic approaches to improve blood flow and myocardium oxygen transport in stable chronic angina.
Informed consent will be obtained in each patient, and the Review board committee of the Docent Institute of Urology, University of Carabobo Medical School, Valencia, will approve the trial. This trial is a continuation of the Protocol ID UIC-3 2007 (Novel Treatment for Coronary Artery Disease, NCT 01228214) and will be also registered in the ClinicalTrials.gov
METHODS
(I) Clinical Methods
At the inclusion period and in each clinical visit all subjects had measurements of BP, HR, body weight/height and measurement of body resistance and reactance for Body Composition Analysis of Total Body water and extra-cellular spaces, Fat-Free-Mass, Fat Mass. Number of anginal episodes, and functional anginal class (CCS) will be recorded in each case.
(II) Laboratory Methods
All patients will have routine measurement of Ion Transport Studies, which includes a 12-hour night (7 pm- 7 am) urine collection, followed by fasting state for measurement of plasma (Na, K, Cl, Mg++, Ionized calcium), RBC (Na, K, H2O content), and urine (Na, K, Cl, Mg++, calcium) electrolytes, along with plasma and urine osmolality, at entry, 4-week, and at 3, 8 and 12-months period.
(III) Cardiovascular Studies
All subjects All subjects had resting 12-lead ECG at entry, and non-invasive hemodynamic and PWA (DynaPulse200M, San Diego, CA) for Aortic Stiffness (Augmentation index, and Travel-Time-Reflected-Wave), Systemic and Brachial Artery Resistance and Compliances, obtained at entry and during clinical visits, including possible emergency attention. EchoC, or Doppler studies will be evaluated at baseline, 6-month, and 12-month periods.
Conditions
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Coronary Heart Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Amiloride,nitrates,clopidogrel,aspirin,statins
Comparative Efficacious Research
Group Type
EXPERIMENTAL
Amiloride
Intervention Type
DRUG
5mg/daily for 12th months
Nitrates, clopidogrel, aspirin, statins
Comparative Efficacious Research
Group Type
ACTIVE_COMPARATOR
Nitrates, clopidogrel, aspirin, statins
Intervention Type
DRUG
Comparative Efficacious Research
Interventions
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Amiloride
5mg/daily for 12th months
Intervention Type
DRUG
Nitrates, clopidogrel, aspirin, statins
Comparative Efficacious Research
Intervention Type
DRUG
Other Intervention Names
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Nitrates (40mg/daily) for 12 months
Clopidogrel(75mg/daily)for 12 months
Aspirin (80mg/daily) for 12 months
Statins (20mg/daily) for 12 months
Nitrates (40mg/daily) for 12 months
Clopidogrel(75mg/daily)for 12 months
Aspirin (80mg/daily) for 12 months
Statins (20mg/daily) for 12 months
Eligibility Criteria
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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
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
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
Minimum Eligible Age
35 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Clinical Research Unit at the Docent Institute of Urology
UNKNOWN
Sponsor Role
collaborator
Northern Metropolitan Hospital
UNKNOWN
Sponsor Role
collaborator
Venezuelan Foundation of Heart Failure
OTHER
Sponsor Role
collaborator
University of Carabobo
OTHER
Sponsor Role
lead
Responsible Party
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Antonio Delgado Leon, MD
Prof. of Medicine, MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Antonio J Delgado-Leon, MD
Role: STUDY_CHAIR
University of Carabobo
Antonio R Delgado-Almeida, MD, FAHA, FACC, APS
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Unit at Docent Institute of Urology
Carlos L Delgado-Leon, MD
Role: STUDY_DIRECTOR
Venezuelan Foundation of Heart Failure
Locations
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Hypertension Research Unit
Valencia, Carabobo, Venezuela
Site Status
Countries
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Venezuela
References
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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
Reference Type
BACKGROUND
Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.
Reference Type
BACKGROUND
Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ. 2003 Jun 28;326(7404):1419. doi: 10.1136/bmj.326.7404.1419.
Reference Type
BACKGROUND
Nicholls SJ, Tuzcu EM, Sipahi I, Grasso AW, Schoenhagen P, Hu T, Wolski K, Crowe T, Desai MY, Hazen SL, Kapadia SR, Nissen SE. Statins, high-density lipoprotein cholesterol, and regression of coronary atherosclerosis. JAMA. 2007 Feb 7;297(5):499-508. doi: 10.1001/jama.297.5.499.
Reference Type
BACKGROUND
Simons M, Annex BH, Laham RJ, Kleiman N, Henry T, Dauerman H, Udelson JE, Gervino EV, Pike M, Whitehouse MJ, Moon T, Chronos NA. Pharmacological treatment of coronary artery disease with recombinant fibroblast growth factor-2: double-blind, randomized, controlled clinical trial. Circulation. 2002 Feb 19;105(7):788-93. doi: 10.1161/hc0802.104407.
Reference Type
BACKGROUND
Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.
Reference Type
BACKGROUND
Jensen FB. Red blood cell pH, the Bohr effect, and other oxygenation-linked phenomena in blood O2 and CO2 transport. Acta Physiol Scand. 2004 Nov;182(3):215-27. doi: 10.1111/j.1365-201X.2004.01361.x.
Reference Type
BACKGROUND
Crawford JH, Isbell TS, Huang Z, Shiva S, Chacko BK, Schechter AN, Darley-Usmar VM, Kerby JD, Lang JD Jr, Kraus D, Ho C, Gladwin MT, Patel RP. Hypoxia, red blood cells, and nitrite regulate NO-dependent hypoxic vasodilation. Blood. 2006 Jan 15;107(2):566-74. doi: 10.1182/blood-2005-07-2668. Epub 2005 Sep 29.
Reference Type
BACKGROUND
Ellsworth ML, Forrester T, Ellis CG, Dietrich HH. The erythrocyte as a regulator of vascular tone. Am J Physiol. 1995 Dec;269(6 Pt 2):H2155-61. doi: 10.1152/ajpheart.1995.269.6.H2155.
Reference Type
BACKGROUND
Dejam A, Hunter CJ, Pelletier MM, Hsu LL, Machado RF, Shiva S, Power GG, Kelm M, Gladwin MT, Schechter AN. Erythrocytes are the major intravascular storage sites of nitrite in human blood. Blood. 2005 Jul 15;106(2):734-9. doi: 10.1182/blood-2005-02-0567. Epub 2005 Mar 17.
Reference Type
BACKGROUND
Bin JP, Doctor A, Lindner J, Hendersen EM, Le DE, Leong-Poi H, Fisher NG, Christiansen J, Kaul S. Effects of nitroglycerin on erythrocyte rheology and oxygen unloading: novel role of S-nitrosohemoglobin in relieving myocardial ischemia. Circulation. 2006 May 30;113(21):2502-8. doi: 10.1161/CIRCULATIONAHA.106.627091. Epub 2006 May 22.
Reference Type
BACKGROUND
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
Reference Type
BACKGROUND
Fuster V. The several faces of clinical trials: from new therapies to failed preventive strategies. Nat Clin Pract Cardiovasc Med. 2006 Apr;3(4):173. doi: 10.1038/ncpcardio0520. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Finimundi HC, Caramori PA, Parker JD. Effect of diuretic therapy on exercise capacity in patients with chronic angina and preserved left ventricular function. J Cardiovasc Pharmacol. 2007 May;49(5):275-9. doi: 10.1097/FJC.0b013e3180385ad7.
Reference Type
BACKGROUND
Other Identifiers
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UIC-5 2008
Identifier Type: -
Identifier Source: org_study_id
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