Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension (RSD4CKD)

30 novembre 2012 aggiornato da: Qijun Shan, The First Affiliated Hospital with Nanjing Medical University

Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension

To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Chronic kidney disease(CKD) is a global and growing public health problem, and its frequency increases with age. The major complications of CKD involve losing renal function and cardiovascular disease, which result in significant morbidity, mortality, and cost. The main measures for treatment of CKD are optimizing drug therapy and renal replacement therapy. Optimizing drug therapy, including vascular angiotensin-converting enzyme inhibitors, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on. However, the situation for treatment of CKD is not satisfying. Sympathetic overactivity plays a key role in the development and progression of CKD. Sympathetic nerve activity was increased in patients with all stages of CKD, which was associated with cardiovascular events and all-cause mortality. At the same time, hypertension and proteinuria become the most important risk factor for progression of CKD. Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce muscle and whole-body sympathetic-nerve activity (MSNA) and whole-body norepinephrine spillover. Simultaneously, a marked reduction in blood pressure, sleep apnea severity and urine micro albumin level is apparent, with a improvement glucose tolerance. Sympathetic activation, high norepinephrine level, hypertension, glucose tolerance abnormity, proteinuria and obstructive sleep apnea are all recognized as independent risk factors for the development and progression of CKD. So, we design this randomized parallel control clinical study to demonstrate whether RSD can slow the progression of CKD and reduce the rate of all-cause mortality effectively and securely.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210000
        • Reclutamento
        • First Affiliated Hospital of Nanjing Medical University
        • Contatto:
        • Investigatore principale:
          • Shan Qi Jun, Professor
        • Investigatore principale:
          • Xing Ch Ying, Professor
        • Investigatore principale:
          • Chen Chun, Professor
        • Sub-investigatore:
          • Zhou X Juan, Professor
        • Sub-investigatore:
          • Qian W Chong, Professor
        • Sub-investigatore:
          • Liu Jia, Professor
        • Sub-investigatore:
          • Yu X Bao, Professor
        • Sub-investigatore:
          • Mao H Juan, Professor
        • Sub-investigatore:
          • Yao Jing, Doctor
        • Sub-investigatore:
          • Xu X Qiang, Doctor
        • Sub-investigatore:
          • Wang X Mei, Nurse
        • Sub-investigatore:
          • Duan X Yan, Master
        • Sub-investigatore:
          • Qiu Min, Master
        • Sub-investigatore:
          • Geng Jie, Master

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Subject is ≥ 18 and ≤75 years of age.
  2. A serum creatinine level of 1.5 to 5.0 mg per deciliter (133 to 442 μmol per liter), a creatinine clearance of 20 to 70 ml per minute per 1.73 m2, with variations of less than 30 percent in the three months before randomization.
  3. Persistent proteinuria (defined by urinary protein excretion of more than 0.3 g per day for three or more months which can evacuate urinary tract infection and overt heart failure [a New York Heart Association class of III or IV]).
  4. Resistant hypertension.
  5. Nondiabetic renal disease.
  6. Subject is willing and able to comply with the protocol
  7. Subject is expected to remain available for follow-up visits at the study center
  8. Subject Informed Consent.

Exclusion Criteria:

  1. Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs.
  2. Connective-tissue disease.
  3. Obstructive uropathy.
  4. Congestive heart failure (New York Heart Association class III or IV).
  5. Subject has significant renovascular abnormalities (a history of prior renal artery intervention, including balloon angioplasty or stenting; double renal artery on one side, distortion, and extension ), measured by abdominal ultrasound or renal angiograms.
  6. Subject has a history of myocardial infarction, unstable angina, cerebrovascular accident or alimentary tract hemorrhage in the previous 3 months.
  7. Subject with sick sinus syndrome.
  8. Subject has a history of allergy to contrast media; psychiatric disorders; drug or alcohol abuse; and pregnancy.
  9. Enrolled in a concurrent study that may confound the results of this study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: RSD+Medicine
The investigators will recruit 50 randomised CKD patients who meet the inclusion criteria. First undergo renal artery angiography procedure to confirm anatomy. If renal artery meet the inclusion criteria, give the renal sympathetic denervation. At the same time, we will use optimal medication to protect renal function. Then we will conduct a clinic follow-up and a telephone follow-up e(Total 36 months).
Procedura: RSD
Contrast renal angiography(iodixanol) was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
Altri nomi:
  • denervazione simpatica renale
  • denervazione renale
  • ablazione renale
Comparatore placebo: Medicine
The investigators aslo will recruit 50 randomised CKD patients who meet the inclusion criteria. There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups. In this group we will use optimal medication just like the RSD+Medicine group. Third we will conduct a clinic and a telephone follow-up(Total 36 months).
Droga: medicine
Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
Altri nomi:
  • farmaco

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
Lasso di tempo: 36 months
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality,doubling of the serum creatinine level or end-stage renal disease in patients with chronic kidney disease and resistant hypertension.
36 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Urinary protein excretion and renal function
Lasso di tempo: 36 months
To evaluation of urinary protein excretion and renal function over time, by the reciprocal of the serum and urinary creatinine level, creatinine clearance and the glomerular filtration rate.
36 months
Blood pressure
Lasso di tempo: 36 months
To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension, which can be measured by ambulatory blood pressure and home blood pressure monitoring.
36 months
Blood sugar
Lasso di tempo: 36 months
In order to study whether RSD can reduce the blood sugar level and insulin resistance of diabetic patients. It will be measured by fasting blood glucose, glycated hemoglobin, fasting insulin .
36 months
Cardiac function and structure
Lasso di tempo: 36 months
The effect of renal sympathetic denervation(RSD) on cardiac function and structure can be measured by echocardiographic(include the degree of cardiac pachynesis, left ventricular ejection fraction，left ventricular end diastolic diameter, ventricular septal thickness and so on).
36 months
Arrhythmia
Lasso di tempo: 36 months
If a new arrhythmia is discovered during the follow-up, it will be recorded. Patients may have symptoms of flustered, palpitations, dizziness, amaurosis, syncope and so on, which can be diagnosed by ECG and Holter.
36 months
Pulse wave velocity
Lasso di tempo: 36 months
So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
36 months
Life quality
Lasso di tempo: 36 months
Life quality on 36-item short-form(SF-36),HRQoL and PRODISQ Health Survey Questionnaire will be carried out during the follow-up to study the patients' life quality.
36 months
Rehospitalization rate
Lasso di tempo: 36 months
To study whether RSD can reduce the patients' rehospitalization rate, which will be measured by questionnaire and telephone follow-ups.
36 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Dialysis
Lasso di tempo: 36 months
In order to study the effect of renal sympathetic denervation on renal function in patients with dialysis, which can be measured by the proportion of patients who do not need dialysis anymore.
36 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigatori

  • Cattedra di studio: Shan Qi Jun, professor, The First Affiliated Hospital with Nanjing Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2012

Completamento primario (Anticipato)

1 agosto 2017

Completamento dello studio (Anticipato)

1 aprile 2018

Date di iscrizione allo studio

Primo inviato

27 novembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

27 novembre 2012

Primo Inserito (Stima)

29 novembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 dicembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 novembre 2012

Ultimo verificato

1 novembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2012-SR-142

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Malattia renale cronica

Prove cliniche su RSD

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Liberia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi