Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

N/AWithdrawnNCT01120613

Northwell Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hypertension

Interventions

ChronotherapyDRUG

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: 1. ACE or ARB 2. Calcium Channel Blockers 3. Alpha Blocker 4. 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Renal transplant more than 1 year ago and not on dialysis. 2. Age between 18 years to 70 years. 3. Known history of HTN on one or more anti-hypertensive medication. 4. Stable anti-hypertensive regimen for past 2 months 5. One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker. 6. Stable immunosuppressive regimen with no dose changes in past 3 months. 7. No hospitalizations for previous 2 months Exclusion Criteria: 1. Inability to consent 2. History of falls 3. Presence of AVF or AVG in both the arms 4. Inability to follow up in renal transplant clinic. 5. History of Atrial fibrillation. 6. Pregnant Women 7. Parkinson's Disease 8. Severe orthostatic Hypotension 9. Severe autonomic dysfunction 10. History of other transplanted organs

Locations (1)

North Shore Long Island Jewish Hospital

Great Neck, New York, United States

Outcomes

Primary Outcomes

Percent drop in mean SBP at night time compared to mean SBP at day time

Time frame: 2 months

Secondary Outcomes

Urine Microalbumin to creatinine ratio

Time frame: 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.

Time frame: 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.

Time frame: 2 months

Data from ClinicalTrials.gov

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