N/A
N=92
Renin-angiotensin-aldosterone System Polymorphisms in Resistant Hypertension and Adverse Cardiovascular Events
Systemic Arterial Hypertension · Hypertension Resistant to Conventional Therapy · Myocardial Infarction · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01173029 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Strokes, Either Fatal or Nonfatal — 24; 7 participants — p=0.19
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Anti-hypertensive drug treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidade Gama Filho
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Strokes, Either Fatal or Nonfatal |
24; 7 | 0.19 |
| SECONDARY Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal |
34; 9 | 0.01 sig |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01173029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.