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
Results First Received: April 21, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Systemic Arterial Hypertension
Hypertension Resistant to Conventional Therapy
Myocardial Infarction
Stroke
Intervention: Drug: Anti-hypertensive drug treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was carried out in outpatient clinics at Instituto Nacional de Cardiologia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who have been diagnosed as secondary hypertension were excluded from the trial before assignment to resistant and pseudo-resistant groups.

Reporting Groups
  Description
Resistant Arterial Hypertension Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h 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.
Pseudo-resistant Arterial Hypertension Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h 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.

Participant Flow:   Overall Study
    Resistant Arterial Hypertension     Pseudo-resistant Arterial Hypertension  
STARTED     61     31  
COMPLETED     61     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Subjects referred from primary care with diagnosis of resistant arterial hypertension. Each one had a clinical visit scheduled in the center within one week of referral. All were taking two AH drugs plus diuretic.

ABP was measured in seated position, after 5 min of rest. If the highest average of two measures was >140/90mmHg, subject was admitted.


Reporting Groups
  Description
Resistant Arterial Hypertension Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h 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.
Pseudo-resistant Arterial Hypertension Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h 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.
Total Total of all reporting groups

Baseline Measures
    Resistant Arterial Hypertension     Pseudo-resistant Arterial Hypertension     Total  
Number of Participants  
[units: participants]
  61     31     92  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     50     20     70  
>=65 years     11     11     22  
Age  
[units: years]
Mean ± Standard Deviation
  52.3  ± 9.6     56.8  ± 9.0     54.4  ± 9.4  
Gender  
[units: participants]
     
Female     40     20     60  
Male     21     11     32  
Region of Enrollment  
[units: participants]
     
Brazil     61     31     92  
Renin-Angiotensin-Aldosterone System Polymorphism [1]
[units: participants]
     
Renin (G1051A) GG     22     10     32  
Renin (G1051A) GA     24     6     30  
Renin (G1051A) AA     15     15     30  
Renin-Angiotensin-Aldosterone System Polymorphism [1]
[units: participants]
     
ACE (I/D) II     12     7     19  
ACE (I/D) ID     29     13     42  
ACE (I/D) DD     20     11     31  
Renin-Angiotensin-Aldosterone System Polymorphism [2]
[units: participants]
     
Angiotensin II type 1 receptor (A1166C) AA     36     26     62  
Angiotensin II type 1 receptor (A1166C) AC     24     5     29  
Angiotensin II type 1 receptor (A1166C) CC     1     0     1  
Renin-Angiotensin-Aldosterone System Polymorphism [3]
[units: participants]
     
aldosterone synthase (C344T) CC     24     9     33  
aldosterone synthase (C344T) TC     30     15     45  
aldosterone synthase (C344T) TT     7     7     14  
Renin-Angiotensin-Aldosterone System Polymorphism [1]
[units: participants]
     
Angiotensinogen (M235T) TT     24     6     30  
Angiotensinogen (M235T) MT     25     15     40  
Angiotensinogen (M235T) MM     12     10     22  
Anti-hypertensive treatment [4]
[units: participants]
  61     31     92  
[1] Genetic assessment was carried out using polymerase chain reaction assay amplification. The following single nucleotide polymorphisms were analyzed: renin (G1051A), angiotensinogen (M235T), ACE (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and mineralocorticoid receptor (G3514C)
[2] Genetic assessment carried out using polymerase chain reaction assay amplification. The following single nucleotide polymorphisms were analyzed: renin (G1051A), angiotensinogen (M235T), ACE (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and mineralocorticoid receptor (G3514C)
[3] Genetic assessment was carried out using polymerase chain reaction assay amplification. The following single nucleotide polymorphisms were analyzed: renin (G1051A), angiotensinogen (M235T), ACE (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and mineralocorticoid receptor (G3514C).
[4] Anti-hypertensive treatment, including regimen, drug and the number of drugs prescribed, was left at discrtion of the physician who carried primary assiatnce.



  Outcome Measures
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1.  Primary:   Strokes, Either Fatal or Nonfatal   [ Time Frame: up to 10 years ]

2.  Secondary:   Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal   [ Time Frame: up to 10 years ]

3.  Post-Hoc:   Polygenic Risk Score   [ Time Frame: up to 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Drugs prescribed were at the discretion of attending physician. The impact of anti-hypertensive drugs on the outcomes was not assessed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paulo Robeto Benchimol Barbosa
Organization: Universidade Gama Filho
phone: +55-21-95320182
e-mail: ecgar@yahoo.com


Publications of Results:
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.


Responsible Party: Paulo Roberto Benchimol Barbosa, Universidade Gama Filho
ClinicalTrials.gov Identifier: NCT01173029     History of Changes
Other Study ID Numbers: 0204/21.07.08
Study First Received: July 29, 2010
Results First Received: April 21, 2011
Last Updated: April 13, 2013
Health Authority: Brazil: Ethics Committee