CRD-740 for Heart Failure

(CARDINAL-HF Trial)

No longer recruiting at 108 trial locations

Overseen By Pirouz Shamszad, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cardurion Pharmaceuticals, Inc.

Must be taking: Heart failure therapy

Disqualifiers: Recent HF exacerbation, planned interventions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, CRD-740, can aid individuals with heart failure, particularly those with impaired heart pumping or filling. Participants will receive either CRD-740 or a placebo (a non-active treatment) for 12 weeks to assess improvements in heart function. This trial may suit individuals who have experienced heart failure symptoms for at least six months and maintain stable heart medication routines. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on stable doses of heart failure therapy for at least 4 weeks before screening, suggesting you may need to continue your current treatment.

Is there any evidence suggesting that CRD-740 is likely to be safe for humans?

Research has shown that CRD-740 is generally safe for people with heart failure. In a previous study, most participants did not experience serious side effects. The study found that CRD-740 increased levels of cGMP, a molecule important for heart health, without causing major problems. While some side effects might occur, the treatment has demonstrated a good safety record so far. Based on the available data, CRD-740 appears safe for people with heart failure. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about CRD-740 because it offers a novel approach to treating heart failure, potentially setting it apart from existing options such as ACE inhibitors, beta-blockers, and diuretics. Unlike these standard treatments, which primarily work by managing symptoms and preventing disease progression, CRD-740 is designed to target the underlying mechanisms of heart failure more directly. This experimental drug works by enhancing cardiac function at a cellular level, which could lead to improved heart performance and better patient outcomes. If successful, CRD-740 might offer a more effective solution for heart failure patients, particularly those who have not responded well to the current standard of care.

What evidence suggests that CRD-740 might be an effective treatment for heart failure?

Research shows that CRD-740, which participants in this trial may receive, may help treat heart failure, particularly in patients with Heart Failure with Reduced Ejection Fraction (HFrEF). Studies found that patients generally tolerated CRD-740 well and experienced increased levels of cGMP, a molecule important for heart health. This increase occurred even when patients took other heart failure medications. Earlier trials confirmed that CRD-740 achieved its main goals in improving patient outcomes. These findings suggest that CRD-740 could be an effective treatment option for people with heart failure. ^{1 3 4 6 7}

Who Is on the Research Team?

Howard Surks, MD

Principal Investigator

Chief Medical and Scientific Officer

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥500 pg/mL at screening.

For Part A: Ejection Fraction ≤40% by echocardiography at screening. NT-proBNP level ≥600 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥1000 pg/mL at screening.

You have echocardiographic evidence of left atrial enlargement.

Exclusion Criteria

Presence of or plan for mechanical circulatory support

Documented EF≥60% within 6 months of screening

Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CRD-740 or placebo at two ascending dose levels over 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CRD-740
• Placebo

How Is the Trial Designed?

Group I: CRD-740 Experimental Treatment 1 Intervention

Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.

Group II: Placebo Placebo Group 1 Intervention

Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.

Who Is Running the Clinical Trial?

Cardurion Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

740+

Citations

1. cardurion.com cardurion.com/cardurion-pharmaceuticals-presents-positive-clinical-results-from-cardinal-hf-phase-2a-clinical-trial-of-pde9-inhibitor-in-patients-with-heart-failure/

Cardurion Pharmaceuticals Presents Positive Clinical ... CRD-740 was generally well-tolerated in patients with HFrEF, a disease representing approximately one-half of patients with chronic heart ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05409183

NCT05409183 | Effectiveness of CRD-740 in Heart Failure Study Overview. This is a study evaluating the effectiveness of CRD-740 in patients with either Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart ...

3. synapse.patsnap.com synapse.patsnap.com/blog/promising-phase-2a-results-for-cardurions-heart-failure-treatment

Promising Phase 2a Results for Cardurion's Heart Failure ... In the CARDINAL-HF Phase 2a trial, CRD-740 successfully met its primary goal among patients suffering from heart failure with reduced ejection fraction.

4. ctv.veeva.com ctv.veeva.com/study/effectiveness-of-crd-740-in-heart-failure

Effectiveness of CRD-740 in Heart Failure (CARDINAL-HF) This is a study evaluating the effectiveness of CRD-740 in patients with either Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/ardurion-success-proof-concept-trial/

Cardurion's PDE9 inhibitor increases cGMP in Phase IIa ... Increases in plasma and urinary cGMP were observed in patients who received CRD‑740 with and without background treatment with sacubitril/ ...

6. cardurion.com cardurion.com/wp-content/uploads/2025/03/Udelson-ESC-Heart-Failure-5.11.24-FINAL.pdf

Diapositive 1 – To assess the safety and tolerability of CRD-740 in pts with HFrEF. – To assess the effect of CRD-740 compared to placebo on plasma cGMP at Week 4.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/83/NCT05409183/SAP_001.pdf

Statistical Analysis Plan The Safety population will consist of all subjects who received at least one dose of CRD-740 or placebo. Subjects will be analyzed according to ...