Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

Study Overview
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Brief Summary
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Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time and the reverse dipping is associated with increased target organ damage and adverse cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is critical. Chronotherapy has been shown to be effective in halting progression in patients with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence and management of nocturnal HTN in transplant patients, which is the object of this study.

Official Title
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Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Chronotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal transplant more than 1 year ago and not on dialysis. Age between 18 years to 70 years. Known history of HTN on one or more anti-hypertensive medication. Stable anti-hypertensive regimen for past 2 months One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker. Stable immunosuppressive regimen with no dose changes in past 3 months. No hospitalizations for previous 2 months Exclusion Criteria: Inability to consent History of falls Presence of AVF or AVG in both the arms Inability to follow up in renal transplant clinic. History of Atrial fibrillation. Pregnant Women Parkinson's Disease Severe orthostatic Hypotension Severe autonomic dysfunction History of other transplanted organs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chronotherapy<br>Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing | Drug: Chronotherapy<br>* Patients identified with nocturnal hypertension while treated with blood pressure medications will have one medication switched from daytime to night time dosing in the following preference: ACE or ARB Calcium Channel Blockers Alpha Blocker Beta Blocker If patient is on only one daytime BP medication, it will be switched to night time dosing. No dose adjustments will be made nor any new medications will be added. Only timing of BP medication will be changed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent drop in mean SBP at night time compared to mean SBP at day time |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Microalbumin to creatinine ratio |  | 2 months | 
| Change in Glomerular filtration rate as measured by MDRD equation. | Serum creatinine as a measure of kidney function will be measured at the begining and end of intervention. | 2 months | 
| 24 hour mean systolic Blood Pressure (SBP) Control | Ambulatory Blood pressure monitoring at the end of intervention will be used to assess 24 hour ( day and nighttime) blood pressure control We hypothesize that night time dosing of medication ( chronotherapy) will not only improve nocturnal hypertension but also improve awake blood pressure and overall 24 hour average SBP control. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturnal Hypertension, Nondipping, Renal Transplant, Chronotherapy