MANP + Sacubitril/Valsartan for Heart Failure
Trial Summary
What is the purpose of this trial?
This trial tests two drugs, Sacubatril/Valsartan and MANP, in people with a challenging type of heart failure and kidney disease. Sacubatril/Valsartan helps relax blood vessels, while MANP may help the heart and kidneys by removing extra salt and water. The goal is to see if these treatments can improve symptoms and heart function.
Will I have to stop taking my current medications?
The trial requires participants to stay on a stable dose of their current diuretic medication for at least 4 weeks before the study and throughout its duration. The protocol does not specify other medication changes, so it's best to discuss your specific medications with the study team.
Is the combination of MANP and Sacubitril/Valsartan safe for heart failure treatment?
Sacubitril/Valsartan is generally considered safe for treating heart failure, with side effects similar to other heart failure medications. However, there is a potential risk of angioedema (swelling under the skin) and possible cognitive effects, which need further study, especially in certain populations.12345
What makes the drug MANP + Sacubitril/Valsartan unique for treating heart failure?
The drug MANP + Sacubitril/Valsartan is unique because it combines the effects of sacubitril/valsartan, which enhances natriuretic peptides (hormones that help regulate blood pressure and fluid balance), with MANP, potentially offering a novel approach to managing heart failure by targeting multiple pathways involved in heart function.678910
Research Team
Paul M McKie
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for adults with heart failure that still have a normal amount of blood pumped from the heart (HFpEF) and also have chronic kidney disease, but not diabetes or severe obesity. They must be on stable diuretic medication and have certain levels of kidney function and symptoms according to NYHA class.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Diet Compliance and Medication Adjustment
Participants receive diet instructions and medication adjustments prior to the active study phase
Crossover Treatment
Participants undergo three crossover treatment visits with different drug/placebo combinations, each followed by a washout period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MANP
- Sacubitril/Valsartan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Horng Chen
Lead Sponsor