NCT00313547TerminatedPhase 4
Impact of High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine on Autonomic Regulation and on Sympathetic Activation in Response to Cold Exposure in Hypertensive Patients With Impaired Glucose Tolerance, Diabetes or Coronary Artery Disease
Montreal Heart Institute2 sites in 1 country40 target enrollmentStarted: April 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Heart rate variability
Study Overview
Brief Summary
The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a documented history of hypertension defined as: SBP > or = 140 mmHg or DBP > or = 90 mmHg if hypertension untreated or patients currently treated for hypertension.
- •Documented CAD or diabetes or impaired glucose tolerance
- •Sinus rhythm
Exclusion Criteria
- •Previous intolerance or allergic reaction to an ACE inhibitor, an ARB or dihydropyridine calcium channel blocker
- •History of angioedema or cough related to previous ACE inhibitor use.
- •Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg in untreated patients
- •Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg in patients currently treated by an ACE inhibitor or an ARB
- •Creatinine clearance < 30 ml/min
- •Significant liver dysfunction
- •Current serum potassium > or = 5 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia resulting in either a serum potassium > or = 5.5 mmol/L or a life-threatening adverse event.
- •History of HF or known LVEF < or = 45%
- •Bilateral renal artery stenosis (or unilateral if only one kidney)
- •Unstable angina, myocardial infarction or coronary revascularization within the last 3 months.
- •Connective tissue disease or chronic inflammatory condition
- •Active malignancy
- •Active infection in the last 2 weeks
- •Inability or any contraindication to perform an exercise test.
Outcomes
Primary Outcomes
Heart rate variability
Secondary Outcomes
- Tolerability
- Renin, aldosterone
- MMPs
- Oxidative stress
- Norepinephrine
- Lactate
- Exercise tolerance at 20 and -8 degree celsius
- Blood pressure
- Impact of selected pharmacogenetic polymorphisms
Investigators
Study Sites (2)
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