NCT04321044Befejeződött
Genetic Based Analysis in Hypertensive Patients
Genetic Based Analysis of Identifying Predictors of Blood Pressure Response in Hypertensive Patients After Renal Denervation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 13.
Rövid összefoglaló (regiszter, angolul)
Many attempts to identify predictors of blood pressure response after renal denervation failed to identify a meaningful determination of blood pressure response. These attempts have been based on demographic parameters, clinical parameters, endocrine inflammatory and other biochemical variables, comorbidities and disease factors. So far the only predictor of blood pressure response is the pre-treatment blood pressure. According to Wilder's law the pre-treatment baseline value is always a determinant for any change due to an intervention, irrespective which biological variable is examined. The investigators propose a genetic approach to identify predictors of blood pressure response after renal denervation. Genetic factors are not subject to changes of clinical parameters, previous or current antihypertensive therapy, hypertension associated organ damages, comorbidities and other potential clinical variables.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 300 (tényleges)
- Első benyújtás
- 2020. febr. 17.
- Kezdés
- 2019. jan. 1.
- Elsődleges befejezés
- 2020. júl. 23.
- Fő szponzor
- University of Erlangen-Nürnberg Medical School
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT04321044
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 300
- 2019. jan. 1. és az elsődleges befejezés (2020. júl. 23.) között
- 3 helyszín, 2 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Individual has renal artery anatomy that is ineligible for treatment including:
- Main renal arteries < 4 mm in diameter or < 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal
- A history of prior renal artery intervention including balloon angioplasty or stenting.
- Multiple main renal arteries in either kidney.
- Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI).
- Individual is currently enrolled in another investigational drug or device trial
Más betegség
- Individual has type 1 diabetes mellitus.
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Laborértékek
- Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD calculation.
- Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.]
Kiket keres a vizsgálat
- Individual is ≥ 18 and ≤ 85 years of age.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
- Renal denervation ≥ 6 months
- 24-h ABPM
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg | Erlangen | Németország | Ismeretlen állapot |
| Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University | Homburg | Németország | Ismeretlen állapot |
| Institute of Cardiovascular and Medical Science | Glasgow | Egyesült Királyság | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.