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Completed

NCT Number: NCT01173029

Renin-angiotensin-aldosterone System Polymorphisms in Resistant 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).

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Key information

Conditions

Systemic Arterial Hypertension Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hypertension Hypertension Resistant to Conventional Therapy Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Cardiologia

Rio de Janeiro, RH, 22240-006, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-hypertensive drug treatment

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidade Gama Filho

Other

Collaborators

  • Instituto Nacional de Cardiologia de Laranjeiras

Registry information

Official study title

Observational Study of the Polymorphisms of the Renin-angiotensin-aldosterone System and Their Relation to Resistant Systemic Arterial Hypertension and Adverse Cardiovascular Events

Acronym: GENHART

Important dates

Study start
2001
Primary completion
2009
Study completion
2010
First posted
Jul 30, 2010
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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