Effects of 6 months intensive vasodilating treatment on vascular resistance and coronary flow reserve in hypertensive patients - VASOMORE

Conditions: MedDRA version: 12.1Level: LLTClassification code 10020772Term: Hypertension
Essential Hypertension and changes in the vasculature related to high blood pressure.
MedDRA version: 12.1Level: LLTClassification code 10015489Term: Essential hypertension, benign
MedDRA version: 12.1Level: LLTClassification code 10015488Term: Essential hypertension
MedDRA version: 12.1Level: LLTClassification code 10015491Term: Essential hypertension, unspecified
MedDRA version: 12.1Level: LLTClassification code 10020775Term: Hypertension arterial

Registration Number: EUCTR2009-017831-16-DK

Lead Sponsor: Institute of pharmacology, Aarhus university

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Alder [25 – 80] år.
-Igangværende stabil antihypertensiv behandling gennem mindst 3 måneder. Blodtryk =120/75 på behandlingen.
-Ejection fraction (bestemt ved biplanemetri med ekkokardiografi) over 45 % ved inklusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Blodtryk = 160/100 ved inklusion
-Graviditet, laktation eller mangelfuld antikonception hos menstruerende kvinder
- Verificeret sekundær hypertension
-Andre sygdomme: betydende hjerteklapsygdom, leversygdom, nyresygdom, diabetes, svær neurologisk sygdom, betydende psykisk sygdom, eller noncompliant personlighed i øvrigt.
-Fastende blodsukker > 6,9 mmol/l.
-Elektrolytforstyrrelser i stabil tilstand.
-Forhøjet s-creatinin > 100 mikromol/l
-Klinisk betydende leverpåvirkning.
-Makroskopisk proteinuri eller hæmaturi ved fravær af nitrit (U-stix).
-BMI > 35 kg/m².
-Allergi overfor projektmedicin.
- Antihypertensiv behandling med kombineret calcium kanal blokker + ACE-hæmmer

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of vasodilatation on the coronary perfusion in patients with essential hypertension;Secondary Objective: To investigate the effect of vasodilatation on minimum forearm resistance, left ventricular mass, systolic and diastolic function;Primary end point(s): Primært endepunkt: CFR, coronar og underarms minimums modstand<br>

Secondary Outcome Measures