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

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.

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

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Quinapril 40 mg
* Drug: Quinapril 10 mg and amlodipine 5 mg


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quinapril 40 mg|nan|
|Drug: Quinapril 10 mg and amlodipine 5 mg|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Renin, aldosterone |  |  | 
| MMPs |  |  | 
| Oxidative stress |  |  | 
| Norepinephrine |  |  | 
| Lactate |  |  | 
| Exercise tolerance at 20 and -8 degree celsius |  |  | 
| Blood pressure |  |  | 
| Impact of selected pharmacogenetic polymorphisms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood pressure, Hypertension, Renin, Aldosterone, Heart rate variability