Status:
ENROLLING_BY_INVITATION
Enhancing the Natriuretic Peptide System in HFpEF
Lead Sponsor:
Horng Chen
Conditions:
Heart Failure With Preserved Ejection Fraction
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 induce...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05279742
Start Date
November 4 2022
End Date
April 1 2027
Last Update
October 9 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905