NCT05498181 Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation
| NCT ID | NCT05498181 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-11 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2022-10-11 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years initiating HD (within 90 days of first HD session) * Thrice-weekly HD * Informed consent * Hemodynamically Stable: Sitting pre-dialysis SBP ≥110 mmHg averaged over prior two weeks or at the baseline visit; no symptomatic hypotension in prior two weeks; no use of midodrine. * Has not taken an ACEi for 36 hours prior to randomization Exclusion Criteria: * Anuria (daily urine volume \<100 mL/day) * Current or any use of sacubitril/valsartan within the past 30 days * History of hypersensitivity or intolerance to any of the study drugs, including ARBs or sacubitril/valsartan * Angioedema related to previous ACE inhibitor, ARB, or ARNI therapy * Serum potassium \>5.5 mEq/L at screening (pre-HD if already on HD) * Acute coronary syndrome, stroke, TIA, major CV surgery, percutaneous coronary intervention or carotid angioplasty within one month * Intended coronary or carotid revascularization within 4 months * Implantation of a cardiac resynchronization therapy device (CRTD) within 3 months or intent to implant a CRTD * History of heart transplant, or planned heart transplant, or with left ventricular assist device * Planned renal transplant within 4 months * Documented untreated ventricular arrhythmia with syncopal episodes within 3 months * Symptomatic bradycardia or 2nd or 3rd degree heart block without a pacemaker * Presence of hemodynamically significant valvular disease or hypertrophic cardiomyopathy or infiltrative cardiomyopathy including suspected or confirmed amyloid heart disease (amyloidosis) * History of malignancy of any organ system within the past year (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence) * Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis with evidence of portal hypertension); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease * Pregnant (positive hCG test) or lactating women * Enrollment in another interventional trial * Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline * Does not have capacity to consent (Folstein mini-mental score of 23 or less) * Any condition that in the opinion of the investigator would make participation not in the best interest of the subject * Women of child-bearing age, unless using two birth control methods. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug and for 7 days off of study drug.
Contact & Investigator
Finnian Mc Causland, MBBCh, MMSc
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05498181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05498181 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05498181 currently recruiting?
Yes, NCT05498181 is actively recruiting participants. Contact the research team at fmccausland@bwh.harvard.edu for enrollment information.
Where is the NCT05498181 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05498181 clinical trial?
NCT05498181 is sponsored by Brigham and Women's Hospital. The principal investigator is Finnian Mc Causland, MBBCh, MMSc at Brigham and Women's Hospital. The trial plans to enroll 100 participants.