New drug combo tested for stubborn heart failure
NCT ID NCT05279742
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how two drugs, Sacubitril/Valsartan (Entresto) and MANP, affect people with a type of heart failure called HFpEF, which also involves chronic kidney disease or shortness of breath during exercise. Researchers will measure changes in body chemicals and kidney function after giving the drugs or a placebo. The goal is to understand how these drugs work in different patient groups, not to cure the condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Group 1: HFpEF-CKD-will consist of 30 subjects with: * 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 * CKD defined as glomerular filtration rate (eGFR) of 15-80 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease equation. Subject needs to be on stable dose of chronic diuretic for at least 4 weeks prior to study and maintained on the same dose for the duration of the study. In addition to the exclusion criteria listed below, to ensure a more homogenous group of subjects, we will exclude subjects with Diabetes or BMI \> 35 (because endogenous natriuretic peptide levels are low in obese subjects). Group 2: HFpEF-EI-will consist of 30 subjects with: * 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 * Glomerular filtration rate (eGFR) of \> 50 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease equation. In addition to the exclusion criteria listed below, to ensure a more homogenous group of subjects, we will exclude subjects with Diabetes or BMI\>35 (because endogenous natriuretic peptide levels are low in obese subjects). Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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