Heart Failure Clinical Trial

Effectiveness of CRD-740 in Heart Failure

Summary

This is a two-part 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. The primary objective in Part B is to determine whether CRD-740 reduces NT-proBNP compared to placebo at Week 12.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

For Part B:

For subjects with EF ≤40%:

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.

For subjects with EF >40%:

EF >40% and left atrial enlargement by echocardiography at screening.
NT-proBNP level ≥300 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥500 pg/mL at screening.
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.

Exclusion Criteria:

Documented EF≥60% within 6 months of screening.
Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.
Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
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.
Prior or planned orthotopic heart transplantation.
Presence of or plan for mechanical circulatory support.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

660

Study ID:

NCT05409183

Recruitment Status:

Active, not recruiting

Sponsor:

Cardurion Pharmaceuticals, Inc.

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There are 122 Locations for this study

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Cardurion Investigative Site
Alexander City Alabama, 35010, United States
Cardurion Investigative Site
Birmingham Alabama, 35211, United States
Cardurion Investigative Site
Fairhope Alabama, 36532, United States
Cardurion Investigative Site
Torrance California, 90502, United States
Cardurion Investigative Site
West Hills California, 91307, United States
Cardurion Investigative Site
Washington District of Columbia, 20010, United States
Cardurion Investigative Site
Hialeah Florida, 33016, United States
Cardurion Investigative Site
Miami Florida, 33133, United States
Cardurion Investigative Site
Miami Florida, 33169, United States
Cardurion Investigative Site
Naples Florida, 34102, United States
Cardurion Investigative Site
Naples Florida, 34109, United States
Cardurion Investigative Site
Tampa Florida, 33612, United States
Cardurion Investigative Site
Zephyrhills Florida, 33541, United States
Cardurion Investigative Site
Atlanta Georgia, 30303, United States
Cardurion Investigative Site
Eatonton Georgia, 31024, United States
Cardurion Investigative Site
Hazel Crest Illinois, 60429, United States
Cardurion Investigative Site
Winfield Illinois, 60190, United States
Cardurion Investigative Site
Wichita Kansas, 67207, United States
Cardurion Investigative Site
Alexandria Louisiana, 71301, United States
Cardurion Investigative Site
Bossier City Louisiana, 71111, United States
Cardurion Investigative Site
Detroit Michigan, 48202, United States
Cardurion Investigative Site
Minneapolis Minnesota, 55417, United States
Cardurion Investigative Site
Jackson Mississippi, 39216, United States
Cardurion Investigative Site
New York New York, 10029, United States
Cardurion Investigative Site
Chapel Hill North Carolina, 27599, United States
Cardurion Investigative Site
Greensboro North Carolina, 27405, United States
Cardurion Investigative Site
Cleveland Ohio, 44195, United States
Cardurion Investigative Site
Portland Oregon, 97239, United States
Cardurion Investigative Site
Pittsburgh Pennsylvania, 15212, United States
Cardurion Investigative Site
Sioux Falls South Dakota, 57105, United States
Cardurion Investigative Site
Germantown Tennessee, 38138, United States
Cardurion Investigative Site
Tullahoma Tennessee, 37388, United States
Cardurion Investigative Site
Allen Texas, 75013, United States
Cardurion Investigative Site
Dallas Texas, 75390, United States
Cardurion Investigative Site
Norfolk Virginia, 23510, United States
Cardurion Investigative Site
Madison Wisconsin, 53792, United States
Cardurion Investigative Site
Blagoevgrad , 2700, Bulgaria
Cardurion Investigative Site
Haskovo , 6300, Bulgaria
Cardurion Investigative Site
Haskovo , 6304, Bulgaria
Cardurion Investigative Site
Kyustendil , 2500, Bulgaria
Cardurion Investigative Site
Pleven , 5806, Bulgaria
Cardurion Investigative Site
Plovdiv , 4002, Bulgaria
Cardurion Investigative Site
Plovdiv , 4003, Bulgaria
Cardurion Investigative Site
Smolyan , 4700, Bulgaria
Cardurion Investigative Site
Sofia , 1202, Bulgaria
Cardurion Investigative Site
Sofia , 1407, Bulgaria
Cardurion Investigative Site
Sofia , 1510, Bulgaria
Cardurion Investigative Site
Sofia , 1527, Bulgaria
Cardurion Investigative Site
Sofia , 1606, Bulgaria
Cardurion Investigative Site
Sofia , 1709, Bulgaria
Cardurion Investigative Site
Edmonton Alberta, T6G 2, Canada
Cardurion Investigative Site
Vancouver British Columbia, V5Z 1, Canada
Cardurion Investigative Site
Victoria British Columbia, V8R 1, Canada
Cardurion Investigative Site
Winnipeg Manitoba, R2H 2, Canada
Cardurion Investigative Site
Saint John's Newfoundland and Labrador, A1B 3, Canada
Cardurion Investigative Site
Halifax Nova Scotia, B3H 3, Canada
Cardurion Investigative Site
Brampton Ontario, L6Z 4, Canada
Cardurion Investigative Site
Oshawa Ontario, L1J 2, Canada
Cardurion Investigative Site
Montréal Quebec, H1T 1, Canada
Cardurion Investigative Site
Montréal Quebec, H3G 1, Canada
Cardurion Investigative Site
Québec Quebec, G1V 4, Canada
Cardurion Investigative Site
Sherbrooke Quebec, J1G 2, Canada
Cardurion Investigative Site
Brandýs Nad Labem-Stará Boleslav , 25001, Czechia
Cardurion Investigative Site
Prague , 12800, Czechia
Cardurion Investigative Site
Prague , 15030, Czechia
Cardurion Investigative Site
Příbram , 26101, Czechia
Cardurion Investigative Site
Balatonfüred , 8230, Hungary
Cardurion Investigative Site
Budapest , 1051, Hungary
Cardurion Investigative Site
Budapest , 1122, Hungary
Cardurion Investigative Site
Budapest , 1134, Hungary
Cardurion Investigative Site
Debrecen , 4032, Hungary
Cardurion Investigative Site
Gyöngyös , 3200, Hungary
Cardurion Investigative Site
Kaposvár , 7400, Hungary
Cardurion Investigative Site
Kistarcsa , 2143, Hungary
Cardurion Investigative Site
Nyíregyháza , 4400, Hungary
Cardurion Investigative Site
Zalaegerszeg , 8900, Hungary
Cardurion Investigative Site
Ashkelon , 78306, Israel
Cardurion Investigative Site
Be'er Ya'aqov , 70300, Israel
Cardurion Investigative Site
Hadera , 38100, Israel
Cardurion Investigative Site
Haifa , 31096, Israel
Cardurion Investigative Site
Haifa , 31999, Israel
Cardurion Investigative Site
Jerusalem , 9000, Israel
Cardurion Investigative Site
Kfar Sava , 44281, Israel
Cardurion Investigative Site
Nahariya , 22100, Israel
Cardurion Investigative Site
Petah Tikva , 49100, Israel
Cardurion Investigative Site
Reẖovot , 76100, Israel
Cardurion Investigative Site
Tiberias , 15208, Israel
Cardurion Investigative Site
Pozzilli Isernia, 86077, Italy
Cardurion Investigative Site
Rozzano Milan, 20089, Italy
Cardurion Investigative Site
Bergamo , 24127, Italy
Cardurion Investigative Site
Milan , 20138, Italy
Cardurion Investigative Site
Palermo , 90127, Italy
Cardurion Investigative Site
Pavia , 27100, Italy
Cardurion Investigative Site
Sassari , 07100, Italy
Cardurion Investigative Site
Wrocław Dolnoslaskie, 50-55, Poland
Cardurion Investigative Site
Chrzanów Malopolskie, 32-50, Poland
Cardurion Investigative Site
Krakow Malopolskie, 30-07, Poland
Cardurion Investigative Site
Grodzisk Mazowiecki Mazowieckie, 30-07, Poland
Cardurion Investigative Site
Tychy Silesia, 43-10, Poland
Cardurion Investigative Site
Jasło Woj. Podkarpackie, 38-20, Poland
Cardurion Investigative Site
Kraków , 30-36, Poland
Cardurion Investigative Site
Lublin , 20078, Poland
Cardurion Investigative Site
Poznań , 61-14, Poland
Cardurion Investigative Site
Wrocław , 50-98, Poland
Cardurion Investigative Site
Wrocław , 51-16, Poland
Cardurion Investigative Site
Łódź , 92-21, Poland
Cardurion Investigative Site
Łódź , 93-51, Poland
Cardurion Investigative Site
Brezno Banskobystricky, 97701, Slovakia
Cardurion Investigative Site
Lučenec Banskobystricky, 98401, Slovakia
Cardurion Investigative Site
Lučenec Banskobystricky, 98439, Slovakia
Cardurion Investigative Site
Trebišov Kosice, 07501, Slovakia
Cardurion Investigative Site
Prešov Presovsky, 08001, Slovakia
Cardurion Investigative Site
Svidník Presovsky, 08901, Slovakia
Cardurion Investigative Site
Bardejov , 08501, Slovakia
Cardurion Investigative Site
High Wycombe Buckinghamshire, HP11 , United Kingdom
Cardurion Investigative Site
Airdrie Lanarkshire, ML6 8, United Kingdom
Cardurion Investigative Site
Isleworth Middlesex, TW7 6, United Kingdom
Cardurion Investigative Site
Clydebank , G81 4, United Kingdom
Cardurion Investigative Site
Dundee , DD1 4, United Kingdom
Cardurion Investigative Site
Glasgow , G4 0S, United Kingdom
Cardurion Investigative Site
Harrow , HA1 3, United Kingdom
Cardurion Investigative Site
Newcastle Upon Tyne , NE1 4, United Kingdom
Cardurion Investigative Site
Stockton-on-Tees , TS19 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

660

Study ID:

NCT05409183

Recruitment Status:

Active, not recruiting

Sponsor:


Cardurion Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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