Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

Northwell Health

Status: Withdrawn

Conditions: Hypertension

Treatments: Drug: Chronotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01120613

10-015A

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

chronotherapy

Experimental group

Description:

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

Treatment:

Drug: Chronotherapy