Hypertension Clinical Trial
Official title:
Low-intensity Extracorporeal Shockwave Therapy With the Nephrospec TM Device for the Treatment of Hypertension in Patients Diagnosed With Chronic Kidney Disease (CKD) : a Randomized, Double-blind Sham-controlled Monocentric Trial
This is a randomized, double-blind sham-controlled monocentric trial. 30 patients that are diagnosed with hypertension and with moderate to severe chronic kidney disease are included in this trial. 20 of them are randomized into the active treatment arm, 10 into the sham arm. Low-intensity extracorporal shock wave (Li-ESWT) sessions (arm1) or sham sessions (arm2), will be administered with a dedicated probe within three consecutive weeks to the kidneys of patients.The study will add data to the effects of the shock wave treatment on blood pressure and will assess whether this treatment improves renal function, perfusion and oxygenation. The study includes a third arm (arm3) in which treatment sessions are administered to patients that were in the placebo group in the first phase of the study (arm2).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2026 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age: 18 years to 80 years. - Patient is diagnosed with Hypertension, i.e. office systolic blood pressure =140 mmHg (as per AHA/ACC guidelines, 2017), currently on stable (over 60 days) medical therapy as prescribed by a physician, of none, one, or more antihypertensive medication classes. Patients will be considered stable if no relevant medication change for over 60 days or for 30 days if there were no previous changes 90 days before the current change. - Patients diagnosed with moderate to severe chronic renal failure (eGFR 20-60 mL/min/1.73m2) who are currently on stable medical therapy as prescribed by a physician. - Patient is able and willing to comply with the required follow-up schedule. - Patient is capable of giving an informed consent. Exclusion Criteria: - Hypertension: Individual's systolic BP is over 180mmHg when receiving stable medical medication regimen as prescribed by a physician, of none, one, or more antihypertensive medication classes at maximally tolerated dose. Hypertension secondary to an identifiable and treatable cause, other than Renal artery stenosis or CKD, or is prescribed a medication that may raise BP. - History of previous renal artery stent. Stent or other intervention involving renal arteries including but not limited to renal denervation procedures. - Kidney conditions non compatible with the study: Patient has an eGFR <20 ml/min/1.73m², is on Dialysis or has had a kidney transplant performed. Active pyelonephritis. History of or current kidney stones. Patients with polycystic kidney disease or a known complicated renal cyst (Bosniak III or higher). - Symptomatic patients (Macrohematuria) with a decrease of over 2 grams in Hb. - Hemoglobin (Hb) = 9 grams per deciliter (blood). - Coagulation issues: Bleeding tendency resulting from hematologic disease. Subjects having INR > 2.5 and PT, PTT and platelet count which deviates from the clinical laboratory normal reference range. - Diseases non compatible with the study: Recent (less than 6 months) history of myocardial infarction, PCI, stroke or hospitalization for HFrEF (heart failure with reduced ejection fraction). Individual has type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c > 10%). - Active Cancer - primary tumor or metastatic, such as liver, renal, testicular, abdominal tumor or local tumor at treatment area.. - Treatment non compatible with the study: Patients that have been treated with immunosuppression in the last 3 months. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. No change in dosing of RAS inhibitors in the month prior to the procedure is required. - Technical impossibility to participate: Local infection of the skin at the area to be in contact with the applicator. - Known allergy to Sonovue® contrast product (hypersensibility to sulfur hexyfluoride or another component). - No other contraindication to SonoVue, ie. patients with right-to-left shunts, severe pulmonary hypertension (pulmonary arterial pressure > 90 mm Hg), uncontrolled systemic hypertension and in adult patients with respiratory distress syndrome (ARDS). - Contraindication to undergo MR-imaging such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia. - Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject/ Unable to obtain consent - Known or suspected non-compliance, drug or alcohol abuse - Individual works night shifts. - Individual is pregnant, breast feeding or planning to become pregnant. - Individual does not want to be informed in case of accidental finding related to individual's health discovered during imaging or other study-related exams. - Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation, - Previous enrolment into the current investigation, - Enrolment of the PI, his/her family members, employees, and other dependent persons |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Nephrology, Centre Hospitalier Universitaire Vaudois | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Menno Pruijm |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic 24-hour ambulatory blood pressure (ABPM) | Assess the Systolic 24-hour ambulatory blood pressure depending on the particpant's arm affiliation | Baseline to 12-weeks (-1/+3weeks) Follow-up post last treatment. | |
Secondary | attended Automatic Office Blood Pressure | Assess the attended Automatic Office Blood Pressure depending on the particpant's arm | baseline to 4 weeks (+3 weeks), 24 weeks (±3 weeks) and 48 weeks (±3 weeks) post last treatment | |
Secondary | unattended Automatic Office Blood Pressure | Assess the unattended Automatic Office Blood Pressure depending on the particpant's arm | from baseline to 4 weeks (+3 weeks), 24 weeks (±3 weeks) and 48 weeks (±3 weeks) post last treatment | |
Secondary | Number, dose or number of medications to maintain blood pressure control | Assess the number, dose or number of medications to maintain blood pressure control depending on the particpant's arm | baseline to 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment | |
Secondary | Serum creatinine levels / eGFR - calculated by CKD - EPI | Assess the serum creatinine levels / eGFR (calculated by CKD - EPI) depending on the particpant's arm | baseline to 4 weeks (+3 weeks), 12 weeks (-1/+3 weeks), 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment. | |
Secondary | Albumin/creatinine ratio (ACR) | Assess the albumin/creatinine ratio (ACR) depending on the particpant's arm | baseline to 4 weeks (+3 weeks), 12 weeks (-1/+3 weeks), 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment. | |
Secondary | CEUS-assessed Perfusion Index (PI) | Assess the CEUS-assessed Perfusion Index (PI) depending on the particpant's arm | baseline to 12 weeks (±3 weeks) | |
Secondary | MRI-assessed oxygenation (R2*), fibrosis (ADC) and Phase-contrast | Assess the MRI-assessed oxygenation (R2*), fibrosis (ADC) and Phase-contrast depending on the particpant's arm | baseline to 12 weeks (±3 weeks) | |
Secondary | Plasma renin activity | Assess the plasma renin activity depending on the particpant's arm | baseline to 12 weeks (±3 weeks) | |
Secondary | Plasma aldosterone levels | Assess the plasma aldosterone levels depending on the particpant's arm | baseline to 12 weeks (±3 weeks) | |
Secondary | Cystatin C levels | Assess the cystatin C levels depending on the particpant's arm | baseline to 12 weeks (±3 weeks) |
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