RAS Peptide Profiles in Patients With Arterial Hypertension

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, open-label, parallel-group study conducted at a single center in Switzerland.

Patients diagnosed with primary arterial hypertension requiring antihypertensive drug Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension. Treatment-naive patients will be started on an intermediate dose monotherapy (treatment period 1). In all patients who do not reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles, measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will be done. A control group with 20 age and gender matched, healthy and normotensive subjects will be recruited to establish the characteristics of the RAS peptide profiles in a comparable but normotensive population.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne; University Hospital, Basel, Switzerland
• Treatments: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil; Perindopril

Criteria

Inclusion Criteria:

• Male or female outpatients with previously untreated non-secondary arterial hypertension, defined as: office-systolic blood pressure ≥ 140 mmHg and ≤ 180 mmHg and office-diastolic blood pressure ≥ 90 mmHg and ≤110 mmHg (ESH grade I and II hypertension).

• Male or female outpatients with previously treated non-secondary arterial Hypertension after a wash out period of 4 weeks (Amendment 07/2016)

• Evaluation of 24h blood pressure measurement fulfills criteria of hypertension: mean systolic blood pressure / diastolic blood pressure ≥ 130/80 on average, ≥ 135/85 during the day, or ≥ 120/70 during the night.

• Age ≥ 18 years

• Body mass index between 18 and 35 kg/m²

• Body weight at least 50 kg

• Ability to understand study procedures and to provide written informed consent

• Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.

• 12-lead ECG without clinically relevant abnormalities (Exception: signs of left ventricular hypertrophy with Sokolow index >3.5mV).

• Female study participants less than one year post-menopausal must, be non-pregnant and non-lactating, and willing to use an adequate and highly effective method of contraception throughout the study and for 1 week after the last dose. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as, implants, injectables, combined oral contraceptives, some intrauterine devices (IUD) (hormonal) in combination with a condom or sterilisation, sexual abstinence or vasectomised partner.

Exclusion Criteria:

• Pregnant or lactating women

• Clinical chemistry results indicating secondary arterial hypertension.

• History of or clinically evident cardiovascular disease (other than arterial hypertension), namely myocardial infarction and valvular heart disease or heart failure.

• Ventricular or dual pacemaker wearers

• Uni- or bilateral renal artery stenosis

• Renal dysfunction, defined as estimated creatinine-clearance < 60 ml/min

• Recipient of kidney transplant

• Moderate or severe hepatic impairment

• Clinically relevant lung disease (e.g. uncontrolled bronchial asthma, chronic obstructive pulmonary disease (COPD))

• History of alcohol abuse

• Loss of ≥ 250 ml of blood within 3 months prior to screening.

• Known hypersensitivity to any of the four antihypertensive drugs or any excipients of the drug formulations

• History or clinical evidence of any disease and / or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.

• Participation in another clinical trial within past 30 days

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.