NCT00424801

Brief Summary

The purpose of this study is to determine if long-term vasodilatory treatment is more effective than the standard treatment in hypertensive patients with microvascular angina pectoris

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

January 19, 2007

Last Update Submit

May 5, 2009

Conditions

Microvascular AnginaHypertension

Outcome Measures

Primary Outcomes (1)

  • Minimal coronary resistance

    8 months

Secondary Outcomes (3)

  • Peripheral vascular resistance

    8 months

  • Work capacity

    8 months

  • Ischemia threshold

    8 months

Study Arms (1)

Vasodilatory

EXPERIMENTAL

Patients in this arm will receive intensive vasodilatory treatment to lower blood pressure

Drug: LercanidipineDrug: ValsartanDrug: NicorandilDrug: DoxazosinDrug: MoxonidinDrug: PindololDrug: Amiloride, hydrochlorothiazide

Interventions

LercanidipineDRUG

Individual titration, max. dose 20 mg OD for 8 months

Also known as: Zanidip
Vasodilatory
ValsartanDRUG

Individual titration, max. dose 160 mg OD for 8 months

Also known as: Diovan
Vasodilatory
NicorandilDRUG

Individual titration, max. dose 20 mg BD for 8 months

Also known as: Angicor
Vasodilatory
DoxazosinDRUG

Individual titration, max. dose 4 mg OD for 8 months

Also known as: Doxazosin "Stada"
Vasodilatory
MoxonidinDRUG

Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 0,2 mg OD for 8 months

Also known as: Moxonidin "Alpharma"
Vasodilatory
PindololDRUG

Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 10 mg OD for 8 months

Also known as: Visken
Vasodilatory
Amiloride, hydrochlorothiazideDRUG

Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 1 tbl. OD for 8 months

Also known as: Sparkal
Vasodilatory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertension
  • angina pectoris CCS class II-IV
  • objective signs of ischemia on exercise-ECG or myocardial SPECT
  • no significant stenosis on angiography (minimal lumen diameter \>50% of relevant reference segment)

You may not qualify if:

  • known allergy to any study medication
  • abnormal lab tests of clinical significance
  • valvular disease of haemodynamic significance
  • known secondary hypertension
  • atrial fibrillation or other significant arrythmias
  • known endocrine disease, nephropathy or hepatic disease
  • present malignant disease
  • pregnancy
  • body mass index \> 30
  • significant chronic obstructive lung disease (FEV1 \< 1.5 l)
  • participant in another study including test medicine
  • present treatment with dipyridamole
  • present treatment with phosphodiesterase-5-inhibitors that the patient does not want to discontinue during the study period
  • heart transplanted patients
  • patients with magnetizable metallic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Microvascular AnginaHypertension

Interventions

lercanidipineValsartanNicorandilDoxazosinmoxonidinePindololamiloride, hydrochlorothiazide drug combination

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialNitratesOrganic ChemicalsNiacinamideNicotinic AcidsAcids, HeterocyclicPyridinesPrazosinQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAmines

Study Officials

  • Michael N Præstholm, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

  • Kent L Christensen, MD, DrMSc

    Aarhus Hospital, medical-cardiologic dept. A

    STUDY DIRECTOR

  • Won Yong Kim, MD, DrMSc

    Skejby Hospital, cardiologic dept. B

    STUDY DIRECTOR

  • Hans Erik Bøtker, MD, DrMSc

    Skejby Hospital, cardiologic dept. B

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations

DK(1)