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Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial (RICH)

Primary Purpose

Acute Kidney Injury, Heart Failure, Contrast Induced Nephropathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham remote ischemic conditioning
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Contrast-induced acute kidney injury, Congestive heart failure, Contrast induced nephropathy, Coronary angiography, Percutaneous coronary intervention, Coronary artery disease, Remote ischemic conditioning, acute coronary syndrome, Acute kidney injury, Major adverse kidney events, Ischemic preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years
  • Diagnosis of heart failure with reduced LVEF <50%
  • Pre-procedure intravenous normal saline fluid restriction status
  • Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (>1%)
  • Referral for coronary angiogram and/or PCI
  • Suspected stable coronary artery disease or acute coronary syndrome

Exclusion Criteria:

  • Inability to give informed consent
  • Unstable BP (SBP > 200 or <80 mmHg) at the time of enrolment
  • Upper limb peripheral arterial disease
  • Unavailability of at least one arm for RIPC/Sham-RIPC application
  • Kidney transplant
  • Renal disease requiring dialysis
  • Prior exposure to contrast media within 72hrs preceding coronary angiography
  • Pregnancy
  • Prisoner

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting
  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Remote ischemic preconditioning

Sham remote ischemic preconditioning

Arm Description

3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Outcomes

Primary Outcome Measures

Contrast-associated acute kidney injury
The investigators define contrast-associated acute kidney injury as a relative increase in serum creatinine of 0.3mg/dl compared with initial creatinine at 48 hours time point after coronary angiography and/or PCI. The will obtain levels of serum creatinine at baseline, then at 24 and 48 hours time points.

Secondary Outcome Measures

6 minute walk distance
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
Major adverse kidney events
Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90).
Brain Natriuretic Peptide (BNP)
BNP is a hormone that is primarily secreted from the ventricular myocardium in response to hemodynamic stimuli such as ventricular volume expansion and pressure overload. The investigators will obtain levels of serum BNP at baseline, then at 24 and 48 hours.

Full Information

First Posted
July 26, 2021
Last Updated
November 2, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04982419
Brief Title
Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
Acronym
RICH
Official Title
Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
Detailed Description
The RICH Trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Heart Failure, Contrast Induced Nephropathy, Coronary Angiography, Percutaneous Coronary Intervention
Keywords
Contrast-induced acute kidney injury, Congestive heart failure, Contrast induced nephropathy, Coronary angiography, Percutaneous coronary intervention, Coronary artery disease, Remote ischemic conditioning, acute coronary syndrome, Acute kidney injury, Major adverse kidney events, Ischemic preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomized to RIPC or sham-RIPC.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic preconditioning
Arm Type
Active Comparator
Arm Description
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Arm Title
Sham remote ischemic preconditioning
Arm Type
Sham Comparator
Arm Description
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Intervention Type
Device
Intervention Name(s)
Remote ischemic preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Intervention Type
Device
Intervention Name(s)
Sham remote ischemic conditioning
Other Intervention Name(s)
Sham-RIPC
Intervention Description
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Primary Outcome Measure Information:
Title
Contrast-associated acute kidney injury
Description
The investigators define contrast-associated acute kidney injury as a relative increase in serum creatinine of 0.3mg/dl compared with initial creatinine at 48 hours time point after coronary angiography and/or PCI. The will obtain levels of serum creatinine at baseline, then at 24 and 48 hours time points.
Time Frame
24 and 48 hours time points
Secondary Outcome Measure Information:
Title
6 minute walk distance
Description
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
Time Frame
1 month
Title
Major adverse kidney events
Description
Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90).
Time Frame
3 months
Title
Brain Natriuretic Peptide (BNP)
Description
BNP is a hormone that is primarily secreted from the ventricular myocardium in response to hemodynamic stimuli such as ventricular volume expansion and pressure overload. The investigators will obtain levels of serum BNP at baseline, then at 24 and 48 hours.
Time Frame
24 and 48 hours time points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years Diagnosis of heart failure with reduced LVEF <50% Pre-procedure intravenous normal saline fluid restriction status Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (>1%) Referral for coronary angiogram and/or PCI Suspected stable coronary artery disease or acute coronary syndrome Exclusion Criteria: Inability to give informed consent Unstable BP (SBP > 200 or <80 mmHg) at the time of enrolment Upper limb peripheral arterial disease Unavailability of at least one arm for RIPC/Sham-RIPC application Kidney transplant Renal disease requiring dialysis Prior exposure to contrast media within 72hrs preceding coronary angiography Pregnancy Prisoner
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oladipupo Olafiranye, MD
Phone
(412) 688-6000
Email
Oladipupo.Olafiranye@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Oussama Khalifa, MD
Phone
(412) 360-6191
Email
oussama.khalifa@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oladipupo Olafiranye, MD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oladipupo Olafiranye, MD
Phone
412-688-6000
Email
Oladipupo.Olafiranye@va.gov
First Name & Middle Initial & Last Name & Degree
Oussama Khalifa, MD
Phone
(412) 360-6191
Email
oussama.khalifa@va.gov
First Name & Middle Initial & Last Name & Degree
Oladipupo Olafiranye, MD
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ion Jovin
Phone
804-675-5419
Email
ion.jovin@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial

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