Official Title: “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”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: April 2007

Intervention(s) in this Clinical Trial

• Drug: Quinapril 40 mg
• Drug: Quinapril 10 mg and amlodipine 5 mg

Primary Measures

• Heart rate variability

Secondary Measures

• Tolerability
• Renin, aldosterone
• MMPs
• Oxidative stress
• Norepinephrine
• Lactate
• Exercise tolerance at 20 and -8 degree celsius
• Blood pressure
• Impact of selected pharmacogenetic polymorphisms

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

Principal 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Montreal Heart Institute

Overall Clinical Trial Officials and Contacts

Michel White, MD Principal Investigator Montreal Heart Institute  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00313547

Study ID Number: MHI 05740

ClinicalTrials.gov Identifier: NCT00313547

Health Authority: Canada: Health Canada