Status:
COMPLETED
INVEST: INternational VErapamil SR Trandolapril STudy
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Abbott
Conditions:
Hypertension
Coronary Artery Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and ...
Detailed Description
INVEST is an investigator initiated international, prospective, randomized study comparing two pharmacotherapy strategies to control hypertension in ambulatory patients with coronary artery disease (C...
Eligibility Criteria
Inclusion
- Male or female
- Age 50 to no upper limit
- Hypertension documented according to the 6th report of the Joint National Committee on Detection and Evaluation of the treatment of high BP (JNC VI) and the need for drug therapy (previously documented hypertension in patients currently taking antihypertensive agents is acceptable)
- Documented CAD (e.g., classic angina pectoris (stable angina pectoris; Heberden angina pectoris), myocardial infarction three or more months ago, abnormal coronary angiography, or concordant abnormalities on two different types of stress tests)
- Willingness to sign informed consent
Exclusion
- Unstable angina, angioplasty, coronary artery bypass graft surgery (CABG) or stroke within one month. Patients taking beta blockers after myocardial infarction are excluded if study enrollment is planned within 12 months of myocardial infarction. No time limitation if not taking beta-blocker.
- Use of a ß-blocker within past two weeks
- Patients without a pacemaker and any of the following:
- Sinus bradycardia (\< 50 beats/min.)
- Sick sinus syndrome
- Atrioventricular (AV)-block of more than 1st degree
- Documented contraindication to verapamil; documented contraindication to both atenolol and hydrochlorothiazide
- Atrial fibrillation/flutter with Wolff-Parkinson-White (WPW)-Syndrome
- Severe heart failure (New York Heart Association \[NYHA\] IV).
- Concomitant illnesses (e.g., severe renal failure \[Serum creatinine ≥4.0 mg/dl\], severe hepatic failure or known cirrhosis, etc.) which may affect outcome variables or where life expectancy is two years or less or which are likely to require frequent hospitalizations and/or treatment adjustments.
- Patients with psychiatric, cognitive, or social (e.g., alcoholism, etc.) conditions that would interfere with giving consent or cooperating or remaining available for follow-up for two years.
Key Trial Info
Start Date :
September 1 1997
Trial Type :
INTERVENTIONAL
End Date :
February 1 2003
Estimated Enrollment :
22000 Patients enrolled
Trial Details
Trial ID
NCT00133692
Start Date
September 1 1997
End Date
February 1 2003
Last Update
September 20 2011
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610-0277