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Renin-angiotensin-aldosterone System Polymorphisms in Resistant Hypertension and Adverse Cardiovascular Events (GENHART)

This study has been completed.
Sponsor:
Collaborator:
Instituto Nacional de Cardiologia de Laranjeiras
Information provided by (Responsible Party):
Paulo Roberto Benchimol Barbosa, Universidade Gama Filho
ClinicalTrials.gov Identifier:
NCT01173029
First received: July 29, 2010
Last updated: April 13, 2013
Last verified: April 2013

July 29, 2010
April 13, 2013
June 2001
November 2009   (final data collection date for primary outcome measure)
Strokes, Either Fatal or Nonfatal [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

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.

Stroke, either fatal or nonfatal [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational CT.

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 patents or relatives and review of medical records.

Complete list of historical versions of study NCT01173029 on ClinicalTrials.gov Archive Site
Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

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.

Composite of acute myocardial infarction and/or stroke either fatal or nonfatal [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational.

Evidence of clinically definite acute myocardial infarction (prolonged > 20min chest pain, not relieved by SL nitrate, ST-T 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 patents or relatives and review of medical records.

Not Provided
Not Provided
 
Renin-angiotensin-aldosterone System Polymorphisms in Resistant Hypertension and Adverse Cardiovascular Events
Observational Study of the Polymorphisms of the Renin-angiotensin-aldosterone System and Their Relation to Resistant Systemic Arterial Hypertension and Adverse Cardiovascular Events

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects of both genders in investigation for resistant systemic arterial hypertension at the Hypertension Unit, whose arterial pressure control was not achieved by primary care assistance despite regular use of three anti-hypertensive drugs, including one diuretic. All subjects received standard drug therapy, aiming at achieving outpatients clinics pressure <140/90mmHg and were re-evaluated up to four weeks later, including 24h ambulatory arterial pressure monitoring.

  • Systemic Arterial Hypertension
  • Hypertension Resistant to Conventional Therapy
  • Myocardial Infarction
  • Stroke
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:
  • Thiazide Diuretics
  • Aldosterone receptor antagonist
  • Beta-blockers
  • ACE inhibitors
  • Angiotensin receptor blockers
  • Calcium channel blockers
  • 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.
    Intervention: Drug: Anti-hypertensive drug treatment
  • 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.
    Intervention: Drug: Anti-hypertensive drug treatment
Benchimol-Barbosa PR, Silva PC, Cordovil I, Barbosa-Filho J. Renin-angiotensin-aldosterone system polymorphisms in resistant arterial hypertension: a genetic risk score for adverse cardiovascular events - GENHART-RIO study. Eur Heart J (2011) 32 (suppl 1): 103-103.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
December 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01173029
0204/21.07.08
No
Paulo Roberto Benchimol Barbosa, Universidade Gama Filho
Universidade Gama Filho
Instituto Nacional de Cardiologia de Laranjeiras
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
Universidade Gama Filho
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP