Heart Failure With Preserved Ejection FractionPhase 1/2NCT05279742
Enhancing the Natriuretic Peptide System in HFpEF
A Phase 1/2 study testing MANP and Sacubitril/Valsartan in people with Heart Failure With Preserved Ejection Fraction and Chronic Kidney Diseases, run by Horng Chen at 1 site in United States.
Trial summary
The purpose of this study is to look at the differences in how individuals with heart failure with preserved ejection fraction in the presence of chronic kidney disease (HFpEF-CKD) and exercise induced dyspnea without objective findings of fluid retention (HFpEF-EI) bodies function using drugs Sacubatril/Valsartan… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Chronic Kidney Diseases
- What is being tested?
- MANP and Sacubitril/Valsartan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Enhancing the Natriuretic Peptide System in HFpEF: A Randomized Double-Blind Placebo-Controlled Triple Crossover Study
The purpose of this study is to look at the differences in how individuals with heart failure with preserved ejection fraction in the presence of chronic kidney disease (HFpEF-CKD) and exercise induced dyspnea without objective findings of fluid retention (HFpEF-EI) bodies function using drugs Sacubatril/Valsartan (Entresto) and MANP.
Read the detailed description
Visit 1
Consent Visit: Possible study participants will meet with study coordinator to review consent form. After enrollment into the study. Diet instructions will be given by a dietician about a no added salt diet, 120 mEq Na/day, which will be maintained throughout the study period. Comprehensive metabolic panel and complete blood count with differential and uring pregnancy test (for premenopausal women) will be obtained as well as a brief physical exam or nursing assessment. Visit 2 will be scheduled at least one week out from consent visit to accommodate diet compliance, unless participant is already compliant with salt intake parameter. Instructions for completing a 24-hour urine collection, and container for Study Visit 2, will be given.
Subjects who are taking angiotensin converting enzyme inhibitors (ACEI) will be switched over to an equivalent dose of Valsartan or Losartan which will be maintained for the rest of the study period.
Visit 2
Participants will start a twenty-four hour urine collection one day prior to the active study day.
Subjects will be admitted to the CRU. First urine void after admission collected (Visit 2 Study Day only). A physical exam or nursing assessment will be done as well as a urine pregnancy test (for premenopausal women). On the active study day, subjects will withhold their usual dose of medications and will be placed in the supine position for 1 hour. During the first 15 minutes, two standard intravenous (IV) catheters will be placed (one in each arm). One catheter will be used for infusion and the other (in the contralateral arm) for blood sampling. A bladder ultrasound will be completed after the participant's first void after admitting to assess for urine retention. Subjects will be asked to drink 10ml/Kg of water to insure sufficient urinary flow. A priming dose (calculated according to body size) of Iohexol, to measure glomerular filtration rate (GFR), is infused, followed by a constant rate IV sustaining dose (calculated according to estimated kidney function) of Iohexol. The subjects will be asked to empty their bladder spontaneously every thirty minutes (if subjects are unable to void every thirty minutes, a urinary catheter will be used upon consent). Throughout the study, at the end of each 30-minute clearance period, subjects will be asked to drink an amount of water equivalent to the sum of the blood losses and the urinary flow.
Blood pressure will be measured at 20-minute intervals by using an automatic blood pressure cuff, and heart rate will be continuously monitored by electrocardiography. Echocardiography will be performed during these baseline clearances to determine left atrial (LA) and LV volumes and systolic and diastolic function.
After the baseline clearance, the subjects will be randomized to receive either a) double placebo (oral and SQ) or b) Oral Sacubatril/valsartan (Entresto 97/103 mg) + SQ placebo or c) SQ MANP (5 µg/Kg) + oral placebo. One hour after the administration of the oral medication, the SQ injection will be administered. Thirty minutes after the administration of SQ injection, the acute saline load will be administered (normal saline 0.9% 0.25 ml/kg/min for 1 hour). Two 30-minute clearances (as outlined above) will be repeated with the subjects in a supine position during the saline infusion. As above, blood samples are collected midway during each clearance and urine samples are obtained every 30 minutes. Echocardiography will be repeated immediately after the end of the saline infusion, after which subjects will be allowed to eat a meal and be dismissed.
The subjects will return after at least 1 week of washout for the second crossover study
Visit 3
Visit 3 will take place the same as described in Visit 2, receiving one of the 2 medication administrations not received on Visit 2: (a) double placebo (oral and SQ) or b) Oral Sacubatril/valsartan (Entresto 97/103 mg) + SQ placebo or c) SQ MANP (5 µg/Kg) + oral placebo).
The subjects will return again after at least 1 week of washout for the third crossover study.
Visit 4
Visit 4 will take place the same as described in Visit 2, receiving the remaining of the medication administrations not received on Visit 2 or Visit 3: (a) double placebo (oral and SQ) or b) Ora Sacubatril/valsartan (Entresto 97/103 mg) + SQ placebo or c) SQ MANP (5 µg/Kg) + oral placebo).
At the end of Visit 4, study participation is complete.
- Being tested
- MANP, Sacubitril/Valsartan, Oral Placebo, Injection Placebo
- Keywords
- Exercise Induced Dyspnea
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANPDrug
Single subcutaneous injection 5 µg/Kg
Sacubitril/ValsartanDrug
Also called Entresto
Oral single dose 97/103 mg
Oral PlaceboDrug
Oral single dose that contains no active ingredient
Injection PlaceboDrug
Single subcutaneous injection that contains no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| HFpEF-CKD with MANP and oral placebo | Experimental | 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. Receives: Drug: MANP; Drug: Oral Placebo |
| HFpEF-EI with MANP and oral placebo | Experimental | 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. Receives: Drug: MANP; Drug: Oral Placebo |
| HFpEF-CKD with Sacbitril/Valsartan with an injected placebo | Experimental | 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. Receives: Drug: Sacubitril/Valsartan; Drug: Injection Placebo |
| HFpEF-EI with Sacbitril/Valsartan with an injected placebo | Experimental | 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. Receives: Drug: Sacubitril/Valsartan; Drug: Injection Placebo |
| HFpEF-CKD with an oral and injected placebo | Placebo comparator | 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. Receives: Drug: Oral Placebo; Drug: Injection Placebo |
| HFpEF-EI with an oral and injected placebo | Placebo comparator | 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. Receives: Drug: Oral Placebo; Drug: Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma ANP
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.
Measured: 24 hours
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
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.
Measured: 24 hours
Secondary outcomes (2)
Change in Plasma NT-pro BNP
Change in Plasma NT-pro BNP (pg/ml) after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD.
Measured: 24 hours
Change in Plasma cGMP
Change in plasma cGMP (pmol/ml) after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start4 Nov 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Horng Chen, Mayo Clinic
- Investigators
- Paul M McKie, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279742
- Sponsor's protocol ID
- 21-008978
- Status last verified
- Oct 2025
- First submitted
- 4 Mar 2022
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Natriuretic Peptide System in HFpEF: A Randomized Double-Blind Placebo-Controlled Triple Crossover Study
- ClinicalTrials.gov ID
- NCT05279742
- Acronym / sponsor ID
- 21-008978
- Keywords
- Exercise Induced Dyspnea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Horng ChenUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the differences in how individuals with heart failure with preserved ejection fraction in the presence of chronic kidney disease (HFpEF-CKD) and exercise induced dyspnea without objective findings of fluid retention (HFpEF-EI) bodies function using drugs Sacubatril/Valsartan (Entresto) and MANP.
Detailed description
Visit 1
Consent Visit: Possible study participants will meet with study coordinator to review consent form. After enrollment into the study. Diet instructions will be given by a dietician about a no added salt diet, 120 mEq Na/day, which will be maintained throughout the study period. Comprehensive metabolic panel and complete blood count with differential and uring pregnancy test (for premenopausal women) will be obtained as well as a brief physical exam or nursing assessment. Visit 2 will be scheduled at least one week out from consent visit to accommodate diet compliance, unless participant is already compliant with salt intake parameter. Instructions for completing a 24-hour urine collection, and container for Study Visit 2, will be given.
Subjects who are taking angiotensin converting enzyme inhibitors (ACEI) will be switched over to an equivalent dose of Valsartan or Losartan which will be maintained for the rest of the study period.
Visit 2
Participants will start a twenty-four hour urine collection one day prior to the active study day.
Subjects will be admitted to the CRU. First urine void after admission collected (Visit 2 Study Day only). A physical exam or nursing assessment will be done as well as a urine pregnancy test (for premenopausal women). On the active study day, subjects will withhold their usual dose of medications and will be placed in the supine position for 1 hour. During the first 15 minutes, two standard intravenous (IV) catheters will be placed (one in each arm). One catheter will be used for infusion and the other (in the contralateral arm) for blood sampling. A bladder ultrasound will be completed after the participant's first void after admitting to assess for urine retention. Subjects will be asked to drink 10ml/Kg of water to insure sufficient urinary flow. A priming dose (calculated according to body size) of Iohexol, to measure glomerular filtration rate (GFR), is infused, followed by a constant rate IV sustaining dose (calculated according to estimated kidney function) of Iohexol. The subjects will be asked to empty their bladder spontaneously every thirty minutes (if subjects are unable to void every thirty minutes, a urinary catheter will be used upon consent). Throughout the study, at the end of each 30-minute clearance period, subjects will be asked to drink an amount of water equivalent to the sum of the blood losses and the urinary flow.
Blood pressure will be measured at 20-minute intervals by using an automatic blood pressure cuff, and heart rate will be continuously monitored by electrocardiography. Echocardiography will be performed during these baseline clearances to determine left atrial (LA) and LV volumes and systolic and diastolic function.
After the baseline clearance, the subjects will be randomized to receive either a) double placebo (oral and SQ) or b) Oral Sacubatril/valsartan (Entresto 97/103 mg) + SQ placebo or c) SQ MANP (5 µg/Kg) + oral placebo. One hour after the administration of the oral medication, the SQ injection will be administered. Thirty minutes after the administration of SQ injection, the acute saline load will be administered (normal saline 0.9% 0.25 ml/kg/min for 1 hour). Two 30-minute clearances (as outlined above) will be repeated with the subjects in a supine position during the saline infusion. As above, blood samples are collected midway during each clearance and urine samples are obtained every 30 minutes. Echocardiography will be repeated immediately after the end of the saline infusion, after which subjects will be allowed to eat a meal and be dismissed.
The subjects will return after at least 1 week of washout for the second crossover study
Visit 3
Visit 3 will take place the same as described in Visit 2, receiving one of the 2 medication administrations not received on Visit 2: (a) double placebo (oral and SQ) or b) Oral Sacubatril/valsartan (Entresto 97/103 mg) + SQ placebo or c) SQ MANP (5 µg/Kg) + oral placebo).
The subjects will return again after at least 1 week of washout for the third crossover study.
Visit 4
Visit 4 will take place the same as described in Visit 2, receiving the remaining of the medication administrations not received on Visit 2 or Visit 3: (a) double placebo (oral and SQ) or b) Ora Sacubatril/valsartan (Entresto 97/103 mg) + SQ placebo or c) SQ MANP (5 µg/Kg) + oral placebo).
At the end of Visit 4, study participation is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HFpEF-CKD with MANP and oral placebo | Experimental | Drug: MANP, Drug: Oral PlaceboSubjects 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. |
| HFpEF-EI with MANP and oral placebo | Experimental | Drug: MANP, Drug: Oral PlaceboSubjects 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. |
| HFpEF-CKD with Sacbitril/Valsartan with an injected placebo | Experimental | Drug: Sacubitril/Valsartan, Drug: Injection PlaceboSubjects 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. |
| HFpEF-EI with Sacbitril/Valsartan with an injected placebo | Experimental | Drug: Sacubitril/Valsartan, Drug: Injection PlaceboSubjects 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. |
| HFpEF-CKD with an oral and injected placebo | Placebo comparator | Drug: Oral Placebo, Drug: Injection PlaceboSubjects 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. |
| HFpEF-EI with an oral and injected placebo | Placebo comparator | Drug: Oral Placebo, Drug: Injection PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MANPSingle subcutaneous injection 5 µg/Kg | Drug | HFpEF-CKD with MANP and oral placebo, HFpEF-EI with MANP and oral placebo |
| Sacubitril/ValsartanAlso: EntrestoOral single dose 97/103 mg | Drug | HFpEF-CKD with Sacbitril/Valsartan with an injected placebo, HFpEF-EI with Sacbitril/Valsartan with an injected placebo |
| Oral PlaceboOral single dose that contains no active ingredient | Drug | HFpEF-CKD with MANP and oral placebo, HFpEF-CKD with an oral and injected placebo, HFpEF-EI with MANP and oral placebo, HFpEF-EI with an oral and injected placebo |
| Injection PlaceboSingle subcutaneous injection that contains no active ingredient | Drug | HFpEF-CKD with Sacbitril/Valsartan with an injected placebo, HFpEF-CKD with an oral and injected placebo, HFpEF-EI with Sacbitril/Valsartan with an injected placebo, HFpEF-EI with an oral and injected placebo |
Primary outcome
Change in Plasma ANP
Time frame: 24 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 MANP
Time frame: 24 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.
2 secondary outcomes
Change in Plasma NT-pro BNP
Time frame: 24 hours
Change in Plasma cGMP
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul M McKie principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MANP and Sacubitril/Valsartan in people with Heart Failure With Preserved Ejection Fraction and Chronic Kidney Diseases, run by Horng Chen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma ANP (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.