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Direct Sodium Removal Treatment for Heart Failure (MOJAVE Trial)
Phase 1 & 2
Recruiting
Led By Jeffrey Turner, MD
Research Sponsored by Sequana Medical N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving maximally tolerated stable doses of guideline-directed medical therapy (GDMT)
Aged ≥18 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 28 (treatment period)
Awards & highlights
MOJAVE Trial Summary
This trial tests a new solution to help heart failure patients who don't respond to traditional treatments.
Who is the study for?
Adults over 18 with heart failure and fluid overload who are resistant to diuretics, weigh at least 110 lbs, have a certain level of kidney function, and experience persistent swelling or elevated heart pressures. They must be on stable heart medications and not pregnant or planning pregnancy without using effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Direct Sodium Removal (DSR) therapy using Infusate 2.0 in patients with stubborn fluid overload despite taking diuretics. Participants will either receive this new treatment or continue their usual care.See study design
What are the potential side effects?
Potential side effects may include reactions related to peritoneal dialysis such as abdominal pain, infection risk at the catheter site, changes in blood sugar levels due to dextrose content, and possible allergic reactions to icodextrin.
MOJAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on the highest safe dose of my prescribed treatment.
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I am 18 years old or older.
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My kidney function, based on a creatinine test, is adequate.
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My body excreted less sodium than expected after a diuretic test.
MOJAVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 to day 28 (treatment period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 28 (treatment period)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse event rate through end of treatment period
Serious adverse event rate through end of treatment period
Secondary outcome measures
Change in Urine sodium output from baseline to end of treatment period
MOJAVE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Direct Sodium Removal (DSR) Infusate 2.0Experimental Treatment1 Intervention
Participants will receive a peritoneal dialysis catheter implant. DSR is to be started 14 days after catheter implantation (= D1) for a period of 4 weeks (D28) on top of optimized usual care for HF, while loop diuretic treatment is suspended. Participants then enter enter a 3 month safety follow-up period (D29-D120) until the end of study (D120).
Group II: Optimized Usual Care for HFActive Control1 Intervention
IV loop diuretic treatment is to be started (or continued) after a 14 days observation period (= D1) and can be continued for up to 4 weeks (D28). Participants then enter enter a 3 month safety follow-up period (D29-D120) until the end of study (D120).
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Who is running the clinical trial?
Sequana Medical N.V.Lead Sponsor
15 Previous Clinical Trials
791 Total Patients Enrolled
3 Trials studying Heart Failure
32 Patients Enrolled for Heart Failure
Jeffrey Turner, MDPrincipal InvestigatorYale Universtiry
Marath Fudim, MD MHSPrincipal InvestigatorDuke University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on blood thinners that cannot be stopped for the trial.You weigh at least 110 pounds at the screening.I haven't had any major heart or stroke events in the last 3 months.Your systolic blood pressure should be between 90 and 180 mmHg.I have had severe high potassium levels in the past 6 months.I have severe liver disease or a history of significant fluid buildup in my abdomen.I have had or am planning to have a heart transplant or get a heart support device.I do not have severe heart failure or major untreated heart valve issues.I do not have any serious health issues that could shorten my life to under a year or affect my safety in the study.I haven't taken part in other clinical trials within the last 30 days.I have or might have low output heart failure.You have a high level of albumin in your urine.I have severe weight loss due to heart disease.I cannot use icodextrin due to health reasons.I am allergic or cannot tolerate SGLT2 inhibitors.I am on the highest safe dose of my prescribed treatment.I am 18 years old or older.I am currently using or have used kidney replacement therapy in the past 6 months.Your hemoglobin level is less than 8 grams per deciliter.Your blood sodium levels are less than 130 mEq/L.I have swelling and more than 5 lbs of extra fluid in my body.My kidney function, based on a creatinine test, is adequate.My body excreted less sodium than expected after a diuretic test.I have diabetes with severe sugar level issues in the last 6 months.I have severe problems with my bladder function.I have severe heart failure, take high doses of diuretics, and had recent hospital visits for it.I cannot undergo peritoneal dialysis or have a PD catheter placed due to health reasons.My heart or kidney condition can improve with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Direct Sodium Removal (DSR) Infusate 2.0
- Group 2: Optimized Usual Care for HF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for subjects in this exploration?
"Clinicaltrials.gov currently lists this trial as actively searching for patients. This study was initially submitted on July 7th of 2023 and has been updated most recently on July 25th of the same year."
Answered by AI
What is the upper limit for enrollees in this clinical trial?
"Affirmative. According to the data on clinicaltrials.gov, this scientific trial is actively enrolling patients. It was initially posted on July 7th 2023 and has been updated as recently as July 25th 23. The research necessitates 33 volunteers from a single site for participation in their endeavour."
Answered by AI
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