Renin-angiotensin-aldosterone System Polymorphisms in Resistant Hypertension and Adverse Cardiovascular Events (GENHART)
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| ClinicalTrials.gov Identifier: NCT01173029 |
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Recruitment Status :
Completed
First Posted : July 30, 2010
Results First Posted : March 6, 2013
Last Update Posted : April 22, 2013
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Renin-angiotensin-aldosterone system (RAAS) polymorphisms influence 24h arterial pressure fluctuation. Resistant systemic arterial hypertension (RSAH) has an increased risk of end organ damage and unfavourable prognosis, whereas pseudo-RSAH usually respond favourably to drug therapy.
To prospectively investigate, in subjects with RSAH in a tropical South American city: 1) Adverse cardiovascular events defined as fatal and non-fatal stroke or acute myocardial infarction (AMI); and 2) the association of RAAS polymorphisms and adverse cardiovascular events in this population.
Study population: 212 hypertensives recruited from primary care assistance (time since first diagnosis of hypertension: 16.5±8.1 years) and without appropriate pressure control, between 2001 and 2006, corresponding to 0.48% of all hypertensives under care (18 new cases/year), 57±10 years old, 66% females. Under drug treatment schedule: three or more drugs including a diuretic. Ninety two randomly selected hypertensives basis had renin-angiotensin-aldosterone system genetic profile determined. Genetic assessment was carried out using a polymerase chain reaction assay amplification technique. The following single nucleotide polymorphisms were analyzed: renin (G1051A), angiotensinogen (M235T), angiotensin converting enzyme-ACE (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and mineralocorticoid receptor (G3514C).
| Condition or disease | Intervention/treatment |
|---|---|
| Systemic Arterial Hypertension Hypertension Resistant to Conventional Therapy Myocardial Infarction Stroke | Drug: Anti-hypertensive drug treatment |
| Study Type : | Observational |
| Actual Enrollment : | 92 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of the Polymorphisms of the Renin-angiotensin-aldosterone System and Their Relation to Resistant Systemic Arterial Hypertension and Adverse Cardiovascular Events |
| Study Start Date : | June 2001 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | December 2010 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Resistant Arterial Hypertension
Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24hr ambulatory pressure monitoring: mean 24hr systolic pressure >/=130 mmHg or mean 24hr diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic. Anti-hypertensive drug treatment was non-investigational and was prescribed at discretion of the physician who performed primary evaluation.
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Drug: Anti-hypertensive drug treatment
Anti-hypertensive drug treatment was non-investigational. Drug regimen, including which drug and the number of drugs prescribed, was left at discretion of the physician who carried primary assistance.
Other Names:
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Pseudo-resistant Arterial Hypertension
Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24hr ambulatory pressure monitoring: mean 24hr systolic pressure <130 mmHg and mean 24hr diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic. Anti-hypertensive drug treatment was non-investigational and was prescribed at discretion of the physician who performed primary evaluation.
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Drug: Anti-hypertensive drug treatment
Anti-hypertensive drug treatment was non-investigational. Drug regimen, including which drug and the number of drugs prescribed, was left at discretion of the physician who carried primary assistance.
Other Names:
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- Strokes, Either Fatal or Nonfatal [ Time Frame: up to 10 years ]
Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.
Death was considered to be related to the event if occurring up to 30 days after the acute event.
Assessment twice an year by active and direct contact to patients or relatives and review of medical records.
- Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal [ Time Frame: up to 10 years ]
Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.
Evidence of clinically definite acute myocardial infarction (prolonged > 20min chest pain, not relieved by sublingual nitrate, ST-T segment deviation on 12-lead surface ECG, elevation of plasma troponin >0.2 ng/dL 6h following chest pain episode).
Death was considered to be related to the event if occurring up to 30 days after the acute event.
Assessment twice an year by active and direct contact to patients or relatives and review of medical records.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects with uncontrolled systemic arterial hypertension despite use of three anti-hypertensive drugs, including one diuretic
Exclusion Criteria:
- Secondary causes of systemic arterial hypertension
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173029
| Brazil | |
| Instituto Nacional de Cardiologia | |
| Rio de Janeiro, RH, Brazil, 22240-006 | |
| Principal Investigator: | Paulo R Benchimol-Barbosa, MD, DSc | Universidade Gama Filho | |
| Principal Investigator: | Priscilla Campos | Universidade Gama Filho | |
| Study Chair: | José Barbosa-Filho, MD, DSc | Universidade Gama Filho | |
| Study Chair: | Ivan Cordovil, MD | Instituto Nacional de Cardiologia, Rio de Janeiro |
| Responsible Party: | Paulo Roberto Benchimol Barbosa, Head Researcher, Universidade Gama Filho |
| ClinicalTrials.gov Identifier: | NCT01173029 |
| Other Study ID Numbers: |
0204/21.07.08 |
| First Posted: | July 30, 2010 Key Record Dates |
| Results First Posted: | March 6, 2013 |
| Last Update Posted: | April 22, 2013 |
| Last Verified: | April 2013 |
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Systemic arterial hypertension Hypertension Resistant to Conventional Therapy Genetic polymorphisms Renin-angiotensin-aldosterone system genetic polymorphism |
Risk markers Adverse events Acute myocardial infarction Stroke |
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Hypertension Myocardial Infarction Coronary Vasospasm Infarction Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Coronary Disease Antihypertensive Agents Calcium Channel Blockers Diuretics |
Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Sodium Chloride Symporter Inhibitors Mineralocorticoid Receptor Antagonists Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Natriuretic Agents Molecular Mechanisms of Pharmacological Action Protease Inhibitors Enzyme Inhibitors Membrane Transport Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Diuretics, Potassium Sparing |