NCT05279742
Enhancing the Natriuretic Peptide System in HFpEF
Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatmentHorng ChenInvestigator-initiated
~60 participants
Updated 2025-10-09 on ClinicalTrials.gov
What's tested:MANPSacubitril/ValsartanOral PlaceboInjection Placebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Plasma ANP
Measured over 24 hours
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Paul M McKie · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Ejection fraction of equal or greater than 55%; and
Evidence of increased LV filling pressures, including at least 2 of the following: average septal-lateral E/e' ratio ≥ 15; tricuspid regurgitation (TR) peak velocity \> 2:8 m/s;
Left atrial volume index \>34mL/m\^2 assessed by echocardiography; and
Previous diagnosis of HF with New York Heart Association (NYHA) functional class II-III symptoms on chronic diuretic therapy; and
Exclusion
Ejection fraction of equal or greater than 55%; and
Previous invasive determination of normal pulmonary capillary wedge pressure ≤ 15 mmHg) at rest and ≥ 25 mmHg during exercise; and
New York Heart Association (NYHA) functional class II-III symptoms; and
Body mass index \> 35.
Blood pressure \< 100/60 or \> 180/100 mmHg.
Diabetes.
Myocardial infarction within 6 months of screening.
Unstable angina within 6 months of screening, or any evidence of myocardial ischemia.
Significant valvular heart diseases.
Hypertrophic, restrictive or obstructive cardiomyopathy.
Constrictive pericarditis.
Primary pulmonary hypertension.
Biopsy proven active myocarditis.
Severe congenital heart diseases.
Cardiac amyloidosis.
Fabry disease.
Sarcoidosis.
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening.
Second or third degree heart block without a permanent cardiac pacemaker.
Stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
Hemoglobin \< 9 g/dl
ALT \> 2 times the upper limit of normal;
Serum sodium of \< 135 mEq/dL or \> 150 mEq/dL
Serum potassium of \< 3.5 mEq/dL or \> 5.7 mEq/dL.
Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data.
Received an investigational drug within 1 month prior to dosing.
Patients with an allergy to iodine;
female subject who is pregnant or breastfeeding.
In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.
What this trial measures
- Change in Plasma ANP24 hours
Change in Plasma ANP (pg/ml) level after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD.
- Change in Composite Score of cGMP, sodium excretion, GFR, and Anx-A1 Plasma cGMP, urinary cGMP, urinary sodium excretion, GFR, ANX-A1acute VE with MANP24 hours
A composite score of change in urinary cGMP (pmol/min), sodium excretion (mEq/min), GFR (ml/min), and Anx-A1 (pg/ml) after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD within each treatment group.