The HOPE-3 trial will evaluate the effects of lipid modification with rosuvastatin and of blood pressure lowering with candesartan/hydrochlorothiazide (HCT) and their combination in a wide range of middle aged people, who are at average risk for…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Arteriële vaatziekten (atherosclerotisch vaatlijden)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The composite of CV death, non-fatal MI, non-fatal stroke, resuscitated cardiac
arrest, heart failure and coronary arterial revascularizations with objective
evidence of ischemia.
Secondary outcome
Secondary Efficacy Outcomes:
· The composite of CV death, non-fatal MI and non-fatal stroke;
· Total mortality
Tertiary Efficacy Outcome:
· Renal dysfunction (end-stage renal disease requiring dialysis or
transplantation, doubling of serum creatinine, development of microalbuminuria
or proteinuria).
Other Efficacy Outcomes:
· New diagnosis of diabetes mellitus;
· Other ischemic events (transient ischemic attack, intermittent claudication,
non-coronary revascularization).
· Cognitive decline will be evaluated in participants ³ 70 years
· Erectile dysfunction in men.
Background summary
Cardiovascular disease (CVD) is the major cause of death and disability
worldwide and most events are potentially preventable. Most previous studies
have evaluated therapies in high-risk patient subsets, such as those with
existent CVD and/or those with substantial elevations in risk factors. Clinical
trials have demonstrated that cholesterol and blood pressure levels can be
effectively and safely lowered with statins and combination blood pressure
lowering drugs and that these therapies can lower CV risk in high-risk people.
However, there are only limited data in people at average risk.
The approach to CV prevention in people at average risk, who constitute the
majority of individuals who develop CVD, remains uncertain. Epidemiological
studies indicate that elevated cholesterol and blood pressure are major risk
factors and account for a substantial proportion (>70%) of the population
attributable risk for CVD. The relationships between cholesterol and blood
pressure respectively to CV risk are continuous, extending well below average
(*normal*) levels.
Study objective
The HOPE-3 trial will evaluate the effects of lipid modification with
rosuvastatin and of blood pressure lowering with
candesartan/hydrochlorothiazide (HCT) and their combination in a wide range of
middle aged people, who are at average risk for vascular events.
Study design
During a 4-week run-in phase, eligible study participants will receive
single-blind therapy with rosuvastatin 10 mg and candesartan/HCT 16/12.5 mg
daily. Individuals with high adherence, who tolerate these therapies will be
randomized to double blind study therapy consisting of rosuvastatin 10 mg/day
vs. rosuvastatin placebo and to candesartan/HCT 16/12.5 mg/day vs.
candesartan/HCT placebo utilizing a 2 x 2 factorial design. Follow-up will
occur 6 weeks after randomization, at 6 months and thereafter every 6 months
for an average of at least 5 years.
Intervention
see study design
Study burden and risks
The patients will visit their general practioner max. 15 times (+ one telephone
call between visit 2 and 3). After the study the patients will be followed for
another 10 years ( one yearly contact for major clinical events).
Venipuncture will be done 9-times. Bruises may evolve.
The study is expected to identify safe and effective CV prevention strategies
which could substantially reduce the risk of CVD in large proportions of the
adult population worldwide.
237 Barton Street, East
L8L 2X2 Hamilton Ontario
CA
237 Barton Street, East
L8L 2X2 Hamilton Ontario
CA
Listed location countries
Age
Inclusion criteria
Women aged >60 with at least two additional CV risk factors and men > 55 with
at least one additional CV risk factor:
-Waist/hip ratio > 0.9 in men and > 0.85 in women
-History of current or recent smoking (regular tobacco use within 5 years)
-Low HDL cholesterol (<1 mmol/L in men and <1.3 mmol/L in women)
-Dysglycemia
-Renal dysfunction
-Family history of premature CHD in first degree relatives;Provision of Informed Consent;Also see page 16 of the Study Protocol
Exclusion criteria
-Documented clinically manifest atherothrombotic CVD
-Clear indication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy
-Clear contra indication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy
-Symptomatic hypotension
-Other safety/contra-indications: i.e.: Chronic liver disease; inflammatory muscle disease; severe renal impairment; concurrent treatment with cyclosporine or a condition likely to result in organ tranplantation and the need for cyclosporine
-concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ACE nhibitor or a thiazide diuretic
-Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
-mental disturbances, which could impair the ability to provide informed consent and to adhere to the trial procedures
-concurrent us of an experimental pharmacological agent;Also see page 16 and 17 of the Study Protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001493-91-NL |
| CCMO | NL18820.018.07 |