A double-blinded, randomised, placebo-controlled, crossover study to assess the efficacy of morning or bed-time Perindopril (10mg) to treat hypertension in adult patients with Obstructive Sleep Apnoea

Dr C Phillips - Principle Investigator0 个研究点目标入组 85 人开始时间: 2011年2月28日最近更新: 2022年8月9日

适应症

试验速览

暂无简介。

•The maximum age is 65 years as stated below. This amendment was approved by the ethics committee on 01/06/2011.

•Abnormal renal function or chronic kidney disease indicated by any of
•1. raised creatinine (>110umol/L)
•2. raised potassium (>5.0 mmol/L)
•3. low eGFR (<60ml/min/1.73m2)
•Severe hypertension (SBP>=180 and/or DBP>=110)
•Drug resistant hypertension defined as taking more than 3 classes of BP medication
•Normal Office BP (< 140/90 mmHg) whilst taking anti-hypertensive medication that does not include an ACE or ARB.
•ACE Inhibitor intolerance (based on the opinion of participants and study physicians) indicated by the development of new cough or symptoms of hypotension (dizziness).
•Unwilling to undergo washout of ACE or ARB medication.
•Shift workers who rotate to night shift.
•Poorly controlled diabetes defined as Glycosolated Haemoglobin (HbA1c) >=8.
•Unstable Angina / Heart Failure (NYHA Class III and IV)/ Stroke.
•Recent (< 6 months) AMI or Revascularisation Procedure.
•Significant Arrhythmia or Atrial Fibrillation.
•Cognitive impairment / Psychiatric disorder / Physically unable to participate.
•Recent OSA treatment with Mandibular Advancement Splint or CPAP exposure (within 3 months of screening) or prior refusal of CPAP treatment.
•Severe OSA (minimum oxygen saturation < 65% or RDI > 80) or excessively sleepy patients at increased risk for driving-related accidents requiring immediate treatment.
•More than 20% of AHI with central apnoeas.

发起方

Dr C Phillips - Principle Investigator