Hypertension Clinical Trial
— EnligHTN-IOfficial title:
Ablation-induced Renal Sympathetic Denervation Trial
Verified date | February 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
Status | Completed |
Enrollment | 47 |
Est. completion date | July 2014 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Office systolic blood pressure that remains =160 mmHg (=150 mmHg for patient with type 2 diabetes) despite the stable use of =3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment - Age =18 and =80 years old - Able and willing to provide written informed consent to participate in the study - Able and willing to comply with the required follow-up schedule Exclusion Criteria: - Prior renal artery intervention (balloon angioplasty or stenting) - Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery - Multiple main renal arteries in either kidney - Main renal arteries <4 mm in diameter or <20 mm in length - eGFR of <45 mL/min per 1.73 m2 using the MDRD formula - Type 1 diabetes - Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure) - Others |
Country | Name | City | State |
---|---|---|---|
Australia | Flinders Medical Centre | Adelaide | South Australia |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Monash Medical Centre | Melbourne | Victoria |
Greece | Hippokration Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Australia, Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Office Diastolic BP Change | Baseline to 6M | ||
Other | Office Systolic BP Change | Baseline to 12M | ||
Other | Office Systolic BP Change | Baseline to 18 months | ||
Other | Office Systolic BP Change | Baseline to 24 months | ||
Other | Office Diastolic BP Change | Baseline to 12 months | ||
Other | Office Diastolic BP Change | Baseline to 18 months | ||
Other | Office Diastolic BP Change | Baseline to 24 months | ||
Other | 24hr Ambulatory Systolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | Baseline to 6 months | |
Other | 24hr Ambulatory Systolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | Baseline to 12 months | |
Other | 24hr Ambulatory Systolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | Baseline to 24 months | |
Other | 24hr Ambulatory Diastolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | Baseline to 6 months | |
Other | 24hr Ambulatory Diastolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | Baseline to 12 months | |
Other | 24hr Ambulatory Diastolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | Baseline to 24 months | |
Other | Urine Albumin to Creatinine Ratio | Baseline | ||
Other | Urine Albumin to Creatinine Ratio | 6 months | ||
Other | Urine Albumin to Creatinine Ratio | 12 months | ||
Other | Urine Albumin to Creatinine Ratio | 18 months | ||
Other | Urine Albumin to Creatinine Ratio | 24 months | ||
Other | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) |
Baseline | |
Other | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) |
6 months | |
Other | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) |
12 months | |
Other | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) |
18 months | |
Other | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) |
24 months | |
Other | Cystatin C | Baseline | ||
Other | Cystatin C | 6 months | ||
Other | Cystatin C | 12 months | ||
Other | Cystatin C | 18 months | ||
Other | Cystatin C | 24 months | ||
Primary | Adverse Events | All device or procedure related adverse events | 24 months | |
Primary | Office Systolic Blood Pressure Change | Baseline to 6 months |
Status | Clinical Trial | Phase | |
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