The objective of this study is to evaluate the safety and performance of the ROX Coupler in subjects with resistant hypertension.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints:
- Change in 24-hour ABPM mean systolic blood pressure (SBP) at six
months as compared to baseline
- Change in mean office SBP at six months as compared to baseline
Secondary outcome
Secondary Endpoints:
- Change in 24-hour ABPM mean diastolic blood pressure (DBP) at six
months as compared to baseline
- Change in mean office DBP at six months as compared to baseline
- Change in mean home SBP and DBP at six months as compared to baseline
- Incidence of complications directly associated with delivery and/or
use of the ROX Coupler
Background summary
Hypertension is a disease that affects more than 76 million adults in the
United States >= 20 years of age1 and approximately one billion individuals
worldwide. According to a 2011 report from the American Heart Association
(AHA) based on NHANES/NCHS data through 2008, one in three adults has high
blood pressure, and 71% of these subjects were undergoing treatment for
hypertension. The AHA further reports that only 47.8% of patients had their
hypertension under control and 52.2% did not have it controlled. A lowering of
blood pressure by even modest amounts has the potential to substantially reduce
morbidity and mortality. A meta-analysis of 61 prospective studies on one
million adult patients indicated that a 10 mmHg reduction in systolic blood
pressure lowered risk of stroke mortality by 40% and lowered risk of ischemic
heart disease mortality by 30%. Furthermore, it is estimated that lowering
diastolic blood pressure by 5 mmHg reduces the risk of stroke by 34% and
reduces the risk of ischemic heart disease by 21%.
When hypertension becomes severe and resistant to medication the patient is no
longer able to maintain goal blood pressure, <140/90 mmHg. The prevalence of
resistant hypertension is projected to increase due to the aging population,
increasing trends in obesity, sleep apnea, and chronic kidney disease.
Resistant hypertension is associated with significant cardiovascular disease
and patients have an increased risk of stroke, dissecting aortic aneurysm,
myocardial infarction, congestive heart failure and renal failure compared to
other hypertensive patients. In many cases, no clinically meaningful
decrease in blood pressure is obtained despite adherence to a recommended
treatment plan. Alternative therapies, such as the ROX Coupler, may address
the significant unmet clinical needs of patients with resistant hypertension
who are unable to control their blood pressure using standard medical
treatment.
Study objective
The objective of this study is to evaluate the safety and performance of the
ROX Coupler in subjects with resistant hypertension.
Study design
This is a prospective, randomized, open-label, multicenter study to evaluate
the safety and performance of the ROX Coupler in patients with resistant
hypertension. Safety and performance of the ROX Coupler will be evaluated in
up to 100 subjects at up to 15 study sites. Patients with documented resistant
hypertension who are interested in participating in the study will provide
informed consent prior to baseline to determine eligibility. Baseline tests
should be performed within 45 days prior to Day 0. Eligible patients will be
enrolled in the study and these patients will be randomized in a 1:1 ratio to
Treatment Group A (ROX Coupler implantation + continuing standard
antihypertensive medication as prescribed by physician) or Control Group B
(continuing standard antihypertensive medications as prescribed by physician).
Randomization will be stratified by study site and previous treatment with
renal denervation. Patients will return for clinical examination at 1 month, 3
month, 6 months, 9 months and 12 months. At 24 and 36 months, the subjects
will be contacted via telephone to assess for home blood pressure and adverse
events. At 6 months, for patients randomized to Control Group B, study
physicians will discuss with patients the possibility to cross-over to
Treatment Group A, if they still meet the protocol eligibility criteria.
Study burden and risks
Risks of the right heart catheterization and/or placement of the ROX Coupler
include, but are not limited to, pain relating to the procedure, swelling in
the leg, bleeding or bruising around the insertion site, blood infections,
damage to your blood vessels, or changes in heart function.
The ROX Coupler may cause swelling in the leg because the vein, close to where
the ROX coupler has been positioned, has narrowed. This narrowed vein could
increase the risk of blood clots.
See Protocol Section 6.1.4 for Anticipated Adverse Events and Appendix IV for
definitions of
150 Calle Iglesia Suite A
San Clemente, CA 92672
US
150 Calle Iglesia Suite A
San Clemente, CA 92672
US
Listed location countries
Age
Inclusion criteria
1. Office Systolic blood pressure >= 140 mmHg based on an average of 3 blood pressure readings;2. Ambulatory Blood Pressure Monitoring (ABPM) daytime average:
• Systolic blood pressure (SBP) >= 135 mmHg;
AND
• Diastolic blood pressure (DBP) >= 85 mmHg ;See Protocol Section 4.4.1 for complete Inclusion Criteria
Exclusion criteria
1. Secondary hypertension attributable to a cause other than sleep apnea
2. Type I diabetes
See Protocol Section 4.4.2 for complete Exclusion Criteria
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 |
|---|---|
| Other | 01642498 |
| CCMO | NL41910.100.12 |