Heart FailurePhase 2CARDINAL-HFNCT05409183
Effectiveness of CRD-740 in Heart Failure
A Phase 2 study testing CRD-740 in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Cardurion Pharmaceuticals, Inc. at 34 sites in 4 countries.
Trial summary
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 Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- CRD-740
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 34 sitesin 4 countries
- Study dates
- 26 May 2022to 25 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or Females ≥18 years of age, at screening.
- Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to 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.
- 5. Stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening.
Who cannot join
- 2. Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.
- 3. Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
- 4. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
- 5. Subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.
- 6. Prior or planned orthotopic heart transplantation.
- 7. Presence of or plan for mechanical circulatory support.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States17 sites
Cardurion Investigative Site
Alexander City, Alabama, 35010
Cardurion Investigative Site
Alexandria, Louisiana, 71301
Cardurion Investigative Site
Allen, Texas, 75013
Cardurion Investigative Site
Atlanta, Georgia, 30303
Cardurion Investigative Site
Birmingham, Alabama, 35211
Cardurion Investigative Site
Fairhope, Alabama, 36532
Cardurion Investigative Site
Greensboro, North Carolina, 27408
Cardurion Investigative Site
Hazel Crest, Illinois, 60429
Cardurion Investigative Site
Hialeah, Florida, 33016
Cardurion Investigative Site
Miami, Florida, 33133
Cardurion Investigative Site
Miami, Florida, 33169
Cardurion Investigative Site
Minneapolis, Minnesota, 55415
Cardurion Investigative Site
Naples, Florida, 34102
Cardurion Investigative Site
Norfolk, Virginia, 23504
Cardurion Investigative Site
Tampa, Florida, 33612
Cardurion Investigative Site
Torrance, California, 90502
Cardurion Investigative Site
Tullahoma, Tennessee, 37388
United Kingdom9 sites
Cardurion Investigative Site
Airdrie, Lanarkshire, ML6 8LL
Cardurion Investigative Site
Clydebank, G81 4DY
Cardurion Investigative Site
Dundee, DD1 4HN
Cardurion Investigative Site
Glasgow, G4 0SF
Cardurion Investigative Site
Harrow, HA1 3UJ
Cardurion Investigative Site
High Wycombe, Buckinghamshire, HP11 2TT
Cardurion Investigative Site
Isleworth, Middlesex, TW7 6AF
Cardurion Investigative Site
Newcastle upon Tyne, NE1 4LP
Cardurion Investigative Site
Stockton-on-Tees, TS19 8PE
Israel7 sites
Cardurion Investigative Site
Ashkelon, 7830604
Cardurion Investigative Site
Be’er Ya‘aqov, 70300
Cardurion Investigative Site
Haifa, 31096
Cardurion Investigative Site
Haifa, 31999
Cardurion Investigative Site
Nahariya, 2210001
Cardurion Investigative Site
Rehovot, 76100
Cardurion Investigative Site
Tiberias, 15208
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects With Chronic 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 Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. The primary objective in Part A is to assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in HFrEF.
Part B of the study was not conducted in favor of redesigned new studies.
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Cardiovascular Diseases, Heart Diseases
- Being tested
- CRD-740, Placebo
- Keywords
- PDE9, Heart Failure, CRD-740, HFpEF, HFrEF
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD-740Drug
Tablets administered orally.
PlaceboDrug
Tablets administered orally.
| Study group | Role | What they receive |
|---|---|---|
| CRD-740 | Experimental | Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks. Receives: Drug: CRD-740 |
| Placebo | Placebo comparator | Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
Efficacy: To assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in subjects with CHFrEF.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start26 May 2022
- Primary completion2 May 2023
- Study completion25 Jul 2023
Why it stopped: Part A of the study was successfully concluded. Part B of the study was not conducted in favor of redesigned new studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Surks, MD, Study director, Chief Medical and Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409183
- Sponsor's protocol ID
- CRD-740-201
- Acronym
- CARDINAL-HF
- Status last verified
- Nov 2024
- First submitted
- 3 Jun 2022
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Udelson JE, Belohlavek J, Dukat A, Ezekowitz J, Goland S, Merkely B, O'Meara E, Petrie MC, Ponikowski P, Senni M, Tokmakova M, Vardeny O, Claggett B, Moore E, Savard M, McKellar H, Surks HK, Solomon SD, McMurray JJV. Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CRD-740, a PDE9 Inhibitor, in Chronic Heart Failure. JACC Heart Fail. 2026 Jan;14(1):102706. doi: 10.1016/j.jchf.2025.102706. Epub 2025 Oct 31.
PubMed 41171251
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects With Chronic Heart Failure (CARDINAL-HF)
- ClinicalTrials.gov ID
- NCT05409183
- Acronym / sponsor ID
- CARDINAL-HF / CRD-740-201
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Cardiovascular Diseases, Heart Diseases
- Keywords
- PDE9, Heart Failure, CRD-740, HFpEF, HFrEF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part A of the study was successfully concluded. Part B of the study was not conducted in favor of redesigned new studies.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. The primary objective in Part A is to assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in HFrEF.
Part B of the study was not conducted in favor of redesigned new studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRD-740 | Experimental | Drug: CRD-740Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPart A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or Females ≥18 years of age, at screening.
- Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to screening
- For Part A:
- 5. Stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening.
Key exclusion criteria (7 listed)
- 2. Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.
- 3. Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
- 4. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
- 5. Subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.
- 6. Prior or planned orthotopic heart transplantation.
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 |
|---|---|---|
| CRD-740Tablets administered orally. | Drug | CRD-740 |
| PlaceboTablets administered orally. | Drug | Placebo |
Primary outcome
Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
Time frame: Baseline to Week 4
Efficacy: To assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in subjects with CHFrEF.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41171251Udelson JE, Belohlavek J, Dukat A, Ezekowitz J, Goland S, Merkely B, O'Meara E, Petrie MC, Ponikowski P, Senni M, Tokmakova M, Vardeny O, Claggett B, Moore E, Savard M, McKellar H, Surks HK, Solomon SD, McMurray JJV. Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CRD-740, a PDE9 Inhibitor, in Chronic Heart Failure. JACC Heart Fail. 2026 Jan;14(1):102706. doi: 10.1016/j.jchf.2025.102706. Epub 2025 Oct 31.
- 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. This study is not recruiting at the moment.
Howard Surks, MD study director
Chief Medical and Scientific Officer
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRD-740 in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Cardurion Pharmaceuticals, Inc. at 34 sites in 4 countries.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, United Kingdom, Israel, Canada. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4. (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409183, which also lists 1 linked publication.
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 19 Dec 2024.