Acute Kidney InjuryPhase 2/3RICHNCT04982419
Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
A Phase 2/3 study testing Remote ischemic preconditioning in people with Acute Kidney Injury and Heart Failure, run by VA Office of Research and Development at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Heart Failure, Contrast Induced Nephropathy
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2021to 31 Mar 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Prior exposure to contrast media within 72hrs preceding coronary angiography
- Pregnancy
- Prisoner
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Oladipupo Olafiranye, MD MS, (214) 857-2923, Oladipupo.Olafiranye@va.gov
Oladipupo Olafiranye, MD MS
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Ning Feng, 412-360-6191, ning.feng@va.gov
- Recruiting
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
Ion Jovin, 804-675-5419, ion.jovin@va.gov
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Heart Failure, Contrast Induced Nephropathy, Coronary Angiography, Percutaneous Coronary Intervention
- Being tested
- Remote ischemic preconditioning, Sham remote ischemic conditioning
- 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
- Medical subject headings
- Acute Kidney Injury, Heart Failure, Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningDevice
Also called RIPC
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Sham remote ischemic conditioningDevice
Also called Sham-RIPC
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes Receives: Device: Remote ischemic preconditioning |
| Sham remote ischemic preconditioning | Sham comparator | 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) Receives: Device: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 and 48 hours time points
Secondary outcomes (3)
6 minute walk distance
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
Measured: 1 month
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).
Measured: 3 months
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.
Measured: 24 and 48 hours time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Nov 2021
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized to RIPC or sham-RIPC.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Oladipupo Olafiranye, MD MS, Principal investigator, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982419
- Sponsor's protocol ID
- NEPH-019-20S
- Other IDs
- 1I01CX002045-01
- Acronym
- RICH
- Status last verified
- Dec 2025
- First submitted
- 26 Jul 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
- ClinicalTrials.gov ID
- NCT04982419
- Acronym / sponsor ID
- RICH / NEPH-019-20S
- Conditions
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized to RIPC or sham-RIPC.
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Device: Remote ischemic preconditioning3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes |
| Sham remote ischemic preconditioning | Sham comparator | Device: Sham remote ischemic conditioning3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningAlso: RIPC3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes | Device | Remote ischemic preconditioning |
| Sham remote ischemic conditioningAlso: Sham-RIPC3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) | Device | Sham remote ischemic preconditioning |
Primary outcome
Contrast-associated acute kidney injury
Time frame: 24 and 48 hours time points
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.
3 secondary outcomes
6 minute walk distance
Time frame: 1 month
Major adverse kidney events
Time frame: 3 months
Brain Natriuretic Peptide (BNP)
Time frame: 24 and 48 hours time points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oladipupo Olafiranye, MD MS principal investigator
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Remote ischemic preconditioning in people with Acute Kidney Injury and Heart Failure, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oladipupo Olafiranye, MD MS ((214) 857-2923, Oladipupo.Olafiranye@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-associated acute kidney injury (time frame: 24 and 48 hours time points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.