Effects of Angiotensin Converting Enzyme Inhibitors on Patency of Arterio-Venous Fistulas: A Randomized Controlled Trial
Primary Purpose
Vascular Access Complication
Status
Recruiting
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Losartan Potassium
multi-vitamins
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Access Complication
Eligibility Criteria
Inclusion Criteria:
All patients who were undergoing Hemodialysis or were intended to start HD within three months between the age of 20 years to 70 years were included in the study
Exclusion Criteria:
- Age less than 20 years or more than 79 years
- In patients who are not expected to start dialysis in next 3 months
- Non-consenting patients
- Patients with diagnosed carcinoma whose life expectancy is less than a year.
- Patients with un-controlled hypertension on multiple regimes of antihypertensive
- Patients allergic to ACE inhibitors
Sites / Locations
- Anas Bin SaifRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Use of ACE inhibitor
placebo group
Arm Description
losartan potassium will be administered 25 mg daily
matched for age and gender
Outcomes
Primary Outcome Measures
primary patency at one year
Secondary Outcome Measures
graft complications
maturation time of fistula
Full Information
NCT ID
NCT05132712
First Posted
November 22, 2021
Last Updated
November 22, 2021
Sponsor
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
1. Study Identification
Unique Protocol Identification Number
NCT05132712
Brief Title
Effects of Angiotensin Converting Enzyme Inhibitors on Patency of Arterio-Venous Fistulas: A Randomized Controlled Trial
Official Title
Effects of Angiotensin Converting Enzyme Inhibitors on Patency of Arterio-Venous Fistulas: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic kidney disease (CKD) is one of the leading health problems imbibing a major portion of health budget worldwide. The global prevalence of CKD is estimated to be 13.4% with approximately 5 to 7 million people needing renal replacement therapy. There is lack of epidemiological surveys regarding CKD but it is estimated to be around 5% and nearly half of them are diabetic. In Pakistan most of the patients undergo hemodialysis as mode of renal replacement as renal transplant centers are few and over burdened. Therefore, a good vascular access for hemodialysis is vital for CKD patients. A functioning arterio-venous fistula (AVF) improves quality of life and morbidity. However, access failure remains a major problem in patients of CKD accounting for third most common cause of admission. There are various options for attaining vascular access but AVF remains the most reliable with less morbidity and better overall patency rate. However, the AVF has its own limitation and has overall patency rate of 50-70% at 1 year and 30-40% at 2 years. This outcome indicates that strategies to prevent occlusion by altering modifiable risk factors are suboptimal and warrant further research.
Patients of CKD often have associated cardiovascular diseases as Ischemic heart disease, left ventricular failure and angina. They are often taking cardio-protective medicines as antiplatelets, angiotensin converting enzymes and calcium channel blockers. Intimal hyperplasia has been shown to be the most important cause of AVF failures.2 Angiotensin II promotes vascular smooth muscle proliferation through various growth factors. Various experimental models have clearly depicted that ACE inhibitors effectively stop smooth muscle growth and intimal hyperplasia in vessel walls. Literature review shows conflicting results in terms of AVF patency when ACE inhibitors are used in conjunction. A study by Jackson RS and colleagues showed that ACE inhibitor were associated with reduced hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.16-0.76; P = .008). Whereas, another study showed no role of ACE inhibitors in preventing graft failure. The possible explanation can be study designs as most studies were retrospective and effects of possible confounders. Moreover, there is lack of research in Pakistan to see the effects of pharmacological drugs on primary patency of AVF among CKD patients.
The rationale of this study is to effectively establish the role of ACE inhibitors in achieving primary patency of AV fistulas while reducing the number of confounders. This will be the first randomized controlled trial conducted in Pakistan. The primary outcome is AVF patency at one year. Secondary outcomes will include graft complications and graft maturation time after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Use of ACE inhibitor
Arm Type
Experimental
Arm Description
losartan potassium will be administered 25 mg daily
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
matched for age and gender
Intervention Type
Drug
Intervention Name(s)
Losartan Potassium
Intervention Description
ACE inhibitor
Intervention Type
Drug
Intervention Name(s)
multi-vitamins
Intervention Description
placebo drug
Primary Outcome Measure Information:
Title
primary patency at one year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
graft complications
Time Frame
1 year
Title
maturation time of fistula
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who were undergoing Hemodialysis or were intended to start HD within three months between the age of 20 years to 70 years were included in the study
Exclusion Criteria:
Age less than 20 years or more than 79 years
In patients who are not expected to start dialysis in next 3 months
Non-consenting patients
Patients with diagnosed carcinoma whose life expectancy is less than a year.
Patients with un-controlled hypertension on multiple regimes of antihypertensive
Patients allergic to ACE inhibitors
Facility Information:
Facility Name
Anas Bin Saif
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anas Saif
Phone
00923341115343
Email
anasbinsaif02@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Angiotensin Converting Enzyme Inhibitors on Patency of Arterio-Venous Fistulas: A Randomized Controlled Trial
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