NCT01180413

Brief Summary

The purpose of this study is to determine whether add-on of intensive vasodilator therapy can improve the coronary perfusion and reduce the total peripheral resistance in patients with ongoing treatment for essential hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

August 11, 2010

Last Update Submit

April 18, 2012

Conditions

Essential HypertensionHigh Blood Pressure

Keywords

Inward eutrophic remodelling

Outcome Measures

Primary Outcomes (1)

  • Coronary Flow Reserve

    Determined by echocardiography

    6 months

Secondary Outcomes (5)

  • Puls Wave Velocity

    6 months

  • Left ventricular mass

    6 months

  • Blood Pressure

    6 months

  • Peripheral Vascular Resistance

    6 months

  • Minimal forearm vascular resistance

    6 months

Study Arms (1)

Vasodilatory

EXPERIMENTAL

Patients in this arm will receive intensive vasodilatory treatment

Drug: AmlodipineDrug: RamiprilDrug: LercanidipineDrug: Losartan

Interventions

AmlodipineDRUG

5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Also known as: Amlodipin
Vasodilatory
RamiprilDRUG

5 mg per day for the first to weeks as add-on to original ongoing antihypertensive treatment. Then upward adjustment to 10 mg per day for 6 months if no intolerable side effects are experienced.

Vasodilatory
LercanidipineDRUG

Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Vasodilatory
LosartanDRUG

Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Vasodilatory

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ongoing antihypertensive treatment for \>3 months
  • Blood pressure \>120/75 during antihypertensive treatment
  • Ejection fraction \> 45%

You may not qualify if:

  • Blood pressure \>160/100
  • Pregnancy
  • fertile women not using safe contraceptives
  • known secondary hypertension
  • valvular disease of haemodynamic significance
  • known endocrine disease, nephropathy or hepatic disease
  • present malignant disease
  • known psychiatric disease
  • abnormal lab tests of clinical significance
  • known allergy to any study medication
  • body mass index \> 35
  • Ongoing antihypertensive treatment with a combination of ACE-inhibitor and Calcium antagonist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital - dept. cardiology (A)

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

AmlodipineRamiprillercanidipineLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesTetrazoles

Study Officials

  • Morten Engholm Pedersen, MD

    Aarhus University and Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Ole Norling Mathiasen, MD, PhD

    Aarhus University and Aarhus University Hospital

    STUDY DIRECTOR

  • Niels Henrik Buus, DMSc

    Aarhus University and Aarhus University Hospital

    STUDY DIRECTOR

  • Ashkan Eftekhari, MD, PhD

    Aarhus University and Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD/PhD-Student

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 12, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

DK(1)