Condition category
Circulatory System
Date applied
13/09/2005
Date assigned
04/11/2005
Last edited
20/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paolo Camici

ORCID ID

Contact details

MRC CSC
Hammersmith Campus
London
W12 0NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VER240/1/01

Study information

Scientific title

Comparison of the effect of anti-hypertensive treatment with verapamil and amlodipine on the coronary vasodilator reserve and the transmural distribution of myocardial blood flow in hypertensive patients with left ventricular hypertrophy

Acronym

Study hypothesis

Beneficial effect of calcium antagonists on coronary vasodilator reserve and transmural distribution of flow in hypertensive patients with left ventricular hypertrophy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hypertension

Intervention

The study will enrol hypertensive patients with a left ventricular septum thickness of 13 mm measured with 2D echocardiogram. The overall duration of the study will be of 13 weeks. The first week will consist of a wash-out/run-in phase, when only diuretic therapy will be allowed.

Thereafter the patients will be assigned following the randomisation list to the double-blinded treatment (group 1: verapamil or matching placebo; group 2: amlodipine or matching placebo).

After a period of 6 weeks of treatment the first positron emission tomography (PET) scan will be performed.

Afterwards, within each group, patients will change double-blind treatment from active drug to matching placebo or vice-versa, for 6 additional weeks at the end of which the second and final PET scan will be performed.

The primary parameter under study i.e. myocardial blood flow, will be measured at rest and after the dipyridamole stress test at the end of each treatment period. Briefly, a radioisotope of water (H2^15O) will be infused through a peripheral vein, subsequently, with the patient lying flat, the scan will be acquired. Once this is completed, dipyridamole is infused via the same catheter for 4 minutes. At the end of the infusion, a further scan with H2^15O will be undertaken. The whole procedure will last approximately 90 minutes. Any treatment for hypertension, except for thiazidic diuretics and phtalimidine derivatives, will not be allowed.

Intervention type

Drug

Phase

Not Specified

Drug names

Verapamil, amlodipine

Primary outcome measures

The primary objective of the study is to compare the Coronary Vasodilator Reserve corrected after treatment with verapamil, placebo and amlodipine in hypertensive subjects with left ventricular hypertrophy. With two treatments, two measurements and a within-subject control.

Secondary outcome measures

Reduction of left ventricular mass

Overall trial start date

01/03/1998

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Blood pressure (measured after 5 minutes in the supine position) 160/100 mmHg based on the mean of 3 recordings within a 1 minute interval
2. Left ventricular septum thickness >=13 mm or left ventricular mass index (LVMI) >=130 g/m2 (men), >=100 g/m2 (women). The measurements will be recorded by echocardiography.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Women of childbearing age without adequate contraception
2. Any documented disease of any of the following systems will be a contraindication to entry into the study: respiratory, renal, digestive, nervous central or peripheral, musculoskeletal, haemolymphopoietic, immune, metabolism
3. Subjects with drug or alcohol addiction

Recruitment start date

01/03/1998

Recruitment end date

31/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC CSC
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Abbott (Germany)

Sponsor details

Knollstrasse 50
Ludwigshafen
67061
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/05/2016: No publications found, study status unverified.