Status:
WITHDRAWN
Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Cardurion Pharmaceuticals, Inc.
Collaborating Sponsors:
Imara, Inc.
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate whether 16 weeks of treatment with IMR-687 is a safe and effective treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The primary objective i...
Eligibility Criteria
Inclusion
- Males or females ≥45 years
- Weight 60 to 160 kg, inclusive
- LVEF ≥45% by echo within 6 months prior to Screening Visit
- Symptoms of HFpEF requiring treatment with a diuretic(s) for at least 30 days prior to Screening
- NYHA class II to IV at the time of Screening
- LV hypertrophy, by echo within 6 months of screening, defined by either LV mass/BSA \>95 g/m² for females and 115 g/m² for males or LV mass/m² for males \>44 g/m2.7 for females and 48 g/m2.7 for males
- NT-proBNP criteria either ≥300 pg/mL if in sinus rhythm or ≥700 pg/mL if in atrial fibrillation at screening
- Elevated LV filling pressure criteria are defined as ONE OR MORE of the following:
- HF hospitalization within 12 months prior to screening
- LA enlargement (LA width (diameter) ≥3.8 cm, LA length ≥5.0 cm, LA area ≥20 cm² , LA volume ≥55 mL, or LA volume index \>29 mL/m²) within 6 months of screening for a participant in sinus rhythm
- Cardiac catheterization with at least one of the following in the 12 months prior to screening: rest LVEDP or PCWP ≥15 mm Hg, exercise PCWP ≥25 mm Hg, or fluid challenge PCWP ≥18 mm Hg
- Echocardiogram criteria of one or more within 6 months of screening for a participant in sinus rhythm: E/e' (mean of lateral and septal) \>13, E/e' lateral \>12, or E/e' septal \>14; or for a participant in atrial fibrillation: E/e' septal \>11
- For WOCBP: Two negative pregnancy tests and the use of highly effective contraception up to 3 months following end of study
Exclusion
- Any prior echocardiographic imaging measurement of LVEF \<40%
- Six-minute walk test (6MWT) distance \<100 m or \>450 m at Screening Visit
- Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of \>80
- Major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to Screening Visit, or an elective PCI within 30 days prior to Screening Visit
- Any clinical event within 6 months prior to Screening Visit that could have reduced the LVEF (eg, myocardial infarction, coronary artery bypass graft) unless an echocardiographic measurement was performed at least 1 month after the event confirming the LVEF to be ≥45%
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05312021
Start Date
April 1 2022
End Date
November 1 2023
Last Update
May 15 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.