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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group 1: HFpEF-CKD-will consist of 30 subjects with:
Ejection fraction of equal or greater than 55%
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24 hours
Awards & highlights
Study Summary
This trial is studying how two drugs affect people with different types of heart failure.
Eligible Conditions
- Diastolic Heart Failure
- Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Composite Score of cGMP, sodium excretion, GFR, and Anx-A1 Plasma cGMP, urinary cGMP, urinary sodium excretion, GFR, ANX-A1acute VE with MANP
Body Weight Changes
Secondary outcome measures
Change in Plasma NT-pro BNP
Change in Plasma cGMP
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: HFpEF-EI with Sacbitril/Valsartan with an injected placeboExperimental Treatment2 Interventions
Subjects with with HFpEF with exercise induced dyspnea (difficult or labored breathing) without clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug Sacbitril/Valsartan and an injected placebo followed by a 1 week washout period.
Group II: HFpEF-EI with MANP and oral placeboExperimental Treatment2 Interventions
Subjects with with HFpEF with exercise induced dyspnea (difficult or labored breathing) without clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug MANP and an oral placebo followed by a 1 week washout period.
Group III: HFpEF-CKD with Sacbitril/Valsartan with an injected placeboExperimental Treatment2 Interventions
Subjects with with HFpEF volume overload in the presence of chronic kidney diseases and clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug Sacbitril/Valsartan and an injected placebo followed by a 1 week washout period.
Group IV: HFpEF-CKD with MANP and oral placeboExperimental Treatment2 Interventions
Subjects with with HFpEF volume overload in the presence of chronic kidney diseases and clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug MANP and an oral placebo followed by a 1 week washout period.
Group V: HFpEF-CKD with an oral and injected placeboPlacebo Group2 Interventions
Subjects with with HFpEF volume overload in the presence of chronic kidney diseases and clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive an oral and injected placebo followed by a 1 week washout period.
Group VI: HFpEF-EI with an oral and injected placeboPlacebo Group2 Interventions
Subjects with with HFpEF with exercise induced dyspnea (difficult or labored breathing) without clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive an oral and injected placebo followed by a 1 week washout period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MANP
2017
Completed Phase 1
~60
Sacubitril/Valsartan
2018
Completed Phase 4
~8060
Oral Placebo
2017
Completed Phase 4
~3500
Find a Location
Who is running the clinical trial?
Horng ChenLead Sponsor
3 Previous Clinical Trials
107 Total Patients Enrolled
2 Trials studying Heart Failure
103 Patients Enrolled for Heart Failure
Paul M McKiePrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Heart Failure
60 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart is working well with an ejection fraction of over 55%.Your heart has difficulty filling with blood, which can be detected by two out of the following: a ratio called average septal-lateral E/e' greater than 15, or tricuspid regurgitation peak velocity greater than 2.8 meters per second.Your kidneys are not functioning normally, which is determined by a blood test called the eGFR. You are taking a type of medication called a loop diuretic for a condition related to your kidneys, and you have been taking it at a stable dose for at least 4 weeks before the study. You will need to continue taking the same dose of medication for the entire duration of the study.An ultrasound test showed that your left atrial volume index is too high, which means your heart may not be working properly.You have been diagnosed with heart failure and have symptoms classified as II-III by the New York Heart Association. You are currently taking medication called loop diuretics to treat it.
Research Study Groups:
This trial has the following groups:- Group 1: HFpEF-CKD with MANP and oral placebo
- Group 2: HFpEF-EI with MANP and oral placebo
- Group 3: HFpEF-CKD with Sacbitril/Valsartan with an injected placebo
- Group 4: HFpEF-EI with Sacbitril/Valsartan with an injected placebo
- Group 5: HFpEF-CKD with an oral and injected placebo
- Group 6: HFpEF-EI with an oral and injected placebo
Awards:
This trial has 0 awards, including: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 any more room for participants in this research project?
"The clinical trial you are inquiring about is not currently recruiting patients. Although this may be the case, it is important to know that there are 567 other trials which are actively seeking participants."
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