Hypertension
Conditions
Keywords
Nocturnal Hypertension, Nondipping, Renal Transplant, Chronotherapy
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.
Interventions
DRUGChronotherapy
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.
Sponsors
Northwell Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent drop in mean SBP at night time compared to mean SBP at day time | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed