Loading clinical trials...

Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction

Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction: a Safety and Efficacy Phase 2 Randomized Clinical Study (SP9In-HFpEF)

NCT05312021•Cardurion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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 is to evaluate whether IMR-687 reduces NT-proBNP compared to placebo in these patients.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. HF hospitalization within 12 months prior to screening
•2. 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
+3 more criteria

Exclusion Criteria

•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 Dates

Start Date

April 1, 2022

Primary Completion Date

September 1, 2023

Completion Date

November 1, 2023

Last Updated

May 15, 2025

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

IMR-687

DRUG

IMR-687 Placebo

OTHER

Prospective Evaluation of AI-ECG for SHD Detection

NCT07057466

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Pulmonary Hypertension (Diagnosis)+2 more

View study

RECRUITING

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

NCT07093528

Heart Failure With Preserved Ejection FractionCoronary Microvascular Dysfunction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of AI-ECG for SHD Detection

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Assessment of CCM in HF With Higher Ejection Fraction