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
| ISRCTN | ISRCTN35563487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35563487 |
| Secondary identifying numbers | VER240/1/01 |
- Submission date
- 13/09/2005
- Registration date
- 04/11/2005
- Last edited
- 20/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Paolo Camici
Scientific
Scientific
MRC CSC
Hammersmith Campus
London
W12 0NN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Verapamil, amlodipine |
| Primary outcome measure | 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 study start date | 01/03/1998 |
| Overall study end date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| 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 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
- England
- United Kingdom
Study participating centre
MRC CSC
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Sponsor information
Abbott (Germany)
Industry
Industry
Knollstrasse 50
Ludwigshafen
67061
Germany
"ROR" |
https://ror.org/02x2gk324 |
|---|
Funders
Funder type
Industry
Abbott (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/05/2016: No publications found, study status unverified.
