Effect of Night Time Antihypertensive on Blood Pressure pattern in CKD III-IV: A Randomized Controlled Trial

Completed

• Conditions: chronic kidney disease patient

• Registration Number: CTRI/2018/01/011581
• Lead Sponsor: IPGMER snd SSKM Hospital

Brief Summary

the present study was conducted in the dept. of Nephrology at IPGMER. The aim was to study the effect of night time dosing of antihypertensives on BP profile of CKD III and IV patients. cardiovascular and renal outcome was evaluated at the end of 1 year. 96 patients were assessed eligibility. All patients underwent ABPM at baseline, 11 patients were excluded due to uncontrolled hypertension, 10 patients had dipping pattern. 75 were randomized into 2 groups. 36 patients were grouped as Awakening group who continue to take their medication as previously prescribed. 39 patients were grouped as Bedtime group who either split their antihypertensive to the night time or add additional antihypertensive at the night time. All patients underwent repeat ABPM at 3 months. final analysis was done at end of 1 year. In results there was significant GFR decline noted in awakening group as compared to bedtime group.10 patients reverted to dipping pattern in bedtime group. the percentage decrease of ACR showed favourable trend in bedtime group. cardiovascular outcomes were similar in both the groups. in conclusion, night time antihypertensive medication provides better renal protection with slowing of eGFR decline

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-26
• Study Completion: 2017-12-29
• Last Update Posted: 2018-01-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.MDRD eGFR ≤ 60 ml/min/1.73 m2, irrespective of underlying NKD 2.Patients of either sex who were 18 years of age or older are eligible.
• 3.Patients on antihypertensives taking ≥ 1 drug(s) of which at least 1 dose is being taken in morning or afternoon 4.Patients should be ambulatory.

Exclusion Criteria

• 1.Suspicion of secondary hypertension, other than CKD.
• 2.Recent stroke (occurring within the previous 3 months).
• 3.Recent acute myocardial infarction.
• 4.Recent hospitalization for heart failure 5.Recent revascularization or planned cardiovascular intervention 6.MDRD eGFR <15 ml/min/1.73 m2 or dialysis requiring 7.Uncontrolled Hypertension (systolic BP>150 mmHg or diastolic BP>90mmHg) 8.Pregnancy 9.Atrial fibrillation Refusal to undergo repeated follow up visits and ambulatory blood pressure monitoring.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. Change in cardiac structure like LV Mass Index and LV ejection fraction	Conversion to dipper from non dipper at 3 months | Change in eGFR and Cardiac structure at 1 year
1. Conversion to dipper pattern from non dipper in two groups	Conversion to dipper from non dipper at 3 months | Change in eGFR and Cardiac structure at 1 year
2. Rate of fall of eGFR in two groups	Conversion to dipper from non dipper at 3 months | Change in eGFR and Cardiac structure at 1 year

Secondary Outcome Measures

Name	Time	Method
Changes in 24 hour proteinuria	1 year

Trial Locations

Locations (1)

SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

SSKM Hospital

🇮🇳Kolkata, WEST BENGAL, India

Vaibhav Tiwari

Principal investigator

9740352874

drvt87@gmail.com