Genetic Epidemiology of Responses to Antihypertensives (GERA)

Mayo Clinic

Status: Completed

Conditions: Hypertension; Cardiovascular Diseases; Heart Diseases

Treatments: Drug: Hydrochlorothiazide; Drug: Candesartan

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00005520

R01HL053330 (U.S. NIH Grant/Contract)

R01HL074735 (U.S. NIH Grant/Contract)

05-004017

Details and patient eligibility

About

To determine whether measured variation in genes coding for components of vasoconstriction and volume regulating systems predict interindividual differences in blood pressure response to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin II receptor blocker, candesartan, in hypertensive African-Americans (N=300 treated with each drug) and in hypertensive European Americans (N=300 treated with each drug).

Full description

BACKGROUND:

Essential hypertension is a common disorder that contributes to morbidity, mortality, and cost of health care, especially among African-Americans. Although a single-drug therapy is commonly prescribed for treatment of hypertension, blood pressure levels are controlled in some individuals but not in others. The study has the potential to identify genes contributing to the etiology of interindividual differences in blood pressure response to diuretic therapy in African-Americans and European Americans.

DESIGN NARRATIVE:

Hypertensive adults were treated with the diuretic hydrochlorothiazide, 25 mg/day, for four weeks; or with the angiotensin II receptor blocker candesartan, 16 mg/day for 2 weeks followed by 32 mg/day for 4 weeks. Interindividual variations in blood pressure responses and in candidate genes coding for components of systems regulating vasoconstriction and volume were measured. In addition, a panel of 500,000 single nucleotide polymorphisms genome-wide was measured in subsets of the most extreme responders and nonresponders to each drug for genome-wide association of analyses.

Enrollment: 1,200 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary (essential) hypertension

Trial design

1,200 participants in 4 patient groups

African American hydrochlorothiazide

Description:

300 African American hypertensives were treated with hydrochlorothiazide 25 mg daily for 4 weeks.

Treatment:

Drug: Hydrochlorothiazide

European American hydrochlorothiazide

Description:

300 European American hypertensives were treated with hydrochlorothiazide 25 mg daily for 4 weeks

Treatment:

Drug: Hydrochlorothiazide

African American candesartan

Description:

300 African American hypertensives were treated with candesartan 16 mg daily for 2 weeks followed by 32 mg daily for 4 weeks

Treatment:

Drug: Candesartan

European American candesartan

Description:

300 European American hypertensives were treated with candesartan 16 mg daily for 2 weeks followed by 32 mg daily for 4 weeks

Treatment:

Drug: Candesartan