Study of Hispanics to Assess Risk Prevention in Prehypertension

Stopped early · Not applicable

Conditions studied: Pre-Hypertension

In brief

The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.

Key facts

Study ID

NCT01025323

Run by

Florida Heart Research Institute

People needed

58

Starts

2007-12-01

Expected to finish

2013-03-01

Last updated by the study team

2013-03-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hispanic men and women age 18 or older
• Mean baseline SBP 130-139 mmHg and DBP 85-89 mmHg on screening visits 1\&2
• Subjects who have access to a telephone
• Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study
• Subjects who are willing and capable of complying with the requirements of the study

You may not qualify if…

• BMI > 35
• Pregnant or breast feeding
• Currently taking any anti-hypertensive medications
• History of cardiovascular disease (Stroke, MI, PCI, CABG)
• Current symptoms of angina or peripheral vascular disease by Rose questionnaire
• Fasting glucose ≥ 126mg/dl) or a history of diabetes and use of antidiabetic medication
• Use of oral corticosteroids > 5days/month on average
• Consumption of more than 21 alcoholic drinks per week or consumption of 6 or more drinks on one occasion twice or more per week in the past 3 months prior to screening visit
• Use of weight loss medications (prescription or over the counter) in the past 3 months prior to screening visit 1 or body weight change > 15 pounds in the 3 months prior to screening visit
• Currently undergoing or planning to undergo treatment for a neoplastic disease
• Clinical significant laboratory test results that are indicative of a serious medical condition
• Renal Insufficiency (GFR<60ml/min as estimated using Cockcroft -Gault formula)
• Any orthopedic or rheumatologic problems that might limit a subject's ability to participate in the physical activity component of the intervention
• Any medical condition which in the judgment of the Investigator places the subject at risk due to his/her participation in the study, is likely to prevent the subject from complying with the requirements of the study or completing the study or which may jeopardize the evaluation of efficacy or safety
• Planning to leave area prior to the anticipated end of participation
• Current participation in another research study

Where it is running

• Florida Heart Research Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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