Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: Chronotherapy

• Registration Number: NCT01120613
• Lead Sponsor: Northwell Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-11
• Primary Completion: 2010-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chronotherapy	Chronotherapy	Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing

Primary Outcome Measures

Name	Time	Method
Percent drop in mean SBP at night time compared to mean SBP at day time	2 months

Secondary Outcome Measures

Name	Time	Method
Urine Microalbumin to creatinine ratio	2 months
Change in Glomerular filtration rate as measured by MDRD equation.	2 months	Serum creatinine as a measure of kidney function will be measured at the begining and end of intervention.
24 hour mean systolic Blood Pressure (SBP) Control	2 months	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.

Trial Locations

Locations (1)

North Shore Long Island Jewish Hospital; 🇺🇸 Great Neck, New York, United States