High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients

Condition(s) targeted: Hypertension

Intervention: Quinapril 40 mg (Drug); Quinapril 10 mg and amlodipine 5 mg (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Montreal Heart Institute

Official(s) and/or principal investigator(s):
Michel White, MD, Principal Investigator, Affiliation: Montreal Heart Institute
Simon de Denus, B. Pharm, MSc, Principal Investigator, Affiliation: Faculty of Pharmacy, University of Montreal/Montreal Heart Institute
Jacques de Champlain, MD, PhD, Principal Investigator, Affiliation: Faculty of Medicine, University of Montreal

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.

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

Primary outcome: Heart rate variability

Secondary outcome:

Tolerability

Renin, aldosterone

MMPs

Oxidative stress

Norepinephrine

Lactate

Exercise tolerance at 20 and -8 degree celsius

Blood pressure

Impact of selected pharmacogenetic polymorphisms

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada

Starting date: April 2006
Ending date: March 2008
Last updated: May 2, 2008