Chronic Kidney Disease Clinical Trial
Official title:
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high
risk for stroke. The use of blood thinking medication in dialysis patients is controversial
and warfarin carries a serious risk for major bleeding.
The Watchman device may be an ideal therapy for this population as after implantation it
allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.
An estimated 25 million North American's have chronic kidney disease (CKD) including 600,000
that require dialysis for end-stage renal disease.The importance of CKD is underscored by the
poor survival, frequent hospitalizations and impaired health related quality of life of
patients with CKD.
Stroke is an important cause of morbidity, mortality and suffering for patients with CKD.
Stroke is approximately 5 to 10 times more common in patients with advanced CKD compared to
non-CKD patients. Atrial fibrillation (AF), the most important risk factor for stroke, occurs
in up to 20.4% of patients with advanced CKD. Observational studies suggest anywhere from an
approximate 56% relative risk reduction to a 2-fold increase in the risk of stroke with
warfarin. Furthermore, the risk of bleeding in patients with advanced CKD is roughly 5-fold
higher than patients without CKD. Although OAC may not prevent strokes in patients with
advanced CKD, it still increases the risk of major bleeding by 1.4 fold.
New stroke prevention strategies in patients with CKD and AF are urgently needed. An
effective strategy must reduce the risk of thromboembolic events while not increasing the
risk of bleeding substantially. Left atrial appendage occlusion (LAAO) with devices such as
the Watchman, represent a unique opportunity to accomplish effective stroke prevention while
mitigating the risk of bleeding in this patient population.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
| Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
| Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
| Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
| Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
| Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
| Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
| Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
| Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
| Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
| Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
| Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
| Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT02208674 -
Early Identification and Action in CKD
|
N/A |