Clinical trial NCT00313547: High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: Blood pressure
Hypertension
Renin
Aldosterone
Heart rate variability
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Heart rate variability
Secondary outcomes:
measure: Tolerability
measure: Renin, aldosterone
measure: MMPs
measure: Oxidative stress
measure: Norepinephrine
measure: Lactate
measure: Exercise tolerance at 20 and -8 degree celsius
measure: Blood pressure
measure: Impact of selected pharmacogenetic polymorphisms
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Michel White, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy, University of Montreal/Montreal Heart Institute
name: Simon de Denus, B. Pharm, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Montreal
name: Jacques de Champlain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: